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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
September 2014

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on October 13, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/02/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #018681		 SUPPL-27 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
09/02/2014 SODIUM ACETATE
NDA #018893		 SUPPL-25 SODIUM ACETATE HOSPIRA Manufacturing (CMC) Approval
09/02/2014 DOXYCYCLINE HYCLATE
ANDA #062337		 SUPPL-24 DOXYCYCLINE HYCLATE STRIDES PHARMA Labeling Approval
09/02/2014 DOXYCYCLINE HYCLATE
ANDA #062432		 SUPPL-24 DOXYCYCLINE HYCLATE MYLAN Labeling Approval
09/02/2014 CLARITHROMYCIN
ANDA #065137		 SUPPL-5 CLARITHROMYCIN IVAX SUB TEVA PHARMS Labeling Approval
09/02/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075292		 SUPPL-18 FLUOXETINE HYDROCHLORIDE SOLIS PHARMS Labeling Approval
09/02/2014 IBANDRONATE SODIUM
ANDA #202235		 ORIG-1 IBANDRONATE SODIUM CHEMI SPA Approval
09/02/2014 IBANDRONATE SODIUM
ANDA #202671		 ORIG-1 IBANDRONATE SODIUM PHARMOBEDIENT Approval
09/02/2014 IBANDRONATE SODIUM
ANDA #203987		 ORIG-1 IBANDRONATE SODIUM AVET LIFESCIENCES Approval
09/03/2014 ARTHROTEC
NDA #020607		 SUPPL-28 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Labeling Approval
09/03/2014 DIGOXIN
ANDA #040282		 SUPPL-13 DIGOXIN RISING Manufacturing (CMC) Approval
09/03/2014 LOVASTATIN
ANDA #075451		 SUPPL-14 LOVASTATIN AUROBINDO PHARMA USA Labeling Approval
09/03/2014 OMEPRAZOLE
ANDA #075876		 SUPPL-32 OMEPRAZOLE STRIDES PHARMA Manufacturing (CMC) Approval
09/03/2014 MELOXICAM
ANDA #077921		 SUPPL-9 MELOXICAM ZYDUS PHARMS USA Labeling Approval
09/03/2014 GRANISETRON HYDROCHLORIDE
ANDA #078808		 SUPPL-7 GRANISETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/03/2014 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #202054		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE REGCON HOLDINGS Approval
09/03/2014 GATIFLOXACIN
ANDA #203189		 ORIG-1 GATIFLOXACIN HIKMA Approval
09/03/2014 MILRINONE LACTATE
ANDA #203280		 ORIG-1 MILRINONE LACTATE HOSPIRA Approval
09/04/2014 ARISTOCORT
NDA #012802		 SUPPL-32 TRIAMCINOLONE DIACETATE FOSUN PHARMA Manufacturing (CMC) Approval
09/04/2014 ARISTOSPAN
NDA #016466		 SUPPL-45 TRIAMCINOLONE HEXACETONIDE ETHYPHARM Manufacturing (CMC) Approval
09/04/2014 BETAMETHASONE DIPROPIONATE
NDA #019137		 SUPPL-14 BETAMETHASONE DIPROPIONATE FOUGERA Manufacturing (CMC) Approval
09/04/2014 BUSULFEX
NDA #020954		 SUPPL-13 BUSULFAN OTSUKA PHARM Manufacturing (CMC) Approval
09/04/2014 NOVOLOG
BLA #020986		 SUPPL-76 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG
BLA #020986		 SUPPL-77 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-76 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-77 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-76 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-77 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG INNOLET
BLA #020986		 SUPPL-76 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG INNOLET
BLA #020986		 SUPPL-77 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG PENFILL
BLA #020986		 SUPPL-76 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG PENFILL
BLA #020986		 SUPPL-77 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 INFUVITE ADULT
NDA #021163		 SUPPL-29 ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K SANDOZ CANADA INC Manufacturing (CMC) Approval
09/04/2014 NOVOLOG MIX 70/30
BLA #021172		 SUPPL-61 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172		 SUPPL-61 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 NOVOLOG MIX 70/30 PENFILL
BLA #021172		 SUPPL-61 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 INFUVITE PEDIATRIC
NDA #021265		 SUPPL-25 ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K SANDOZ CANADA INC Manufacturing (CMC) Approval
09/04/2014 INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
NDA #021265		 SUPPL-25 ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K SANDOZ CANADA INC Manufacturing (CMC) Approval
09/04/2014 ANTARA (MICRONIZED)
NDA #021695		 SUPPL-11 FENOFIBRATE LUPIN Manufacturing (CMC) Approval
09/04/2014 METROGEL
NDA #021789		 SUPPL-5 METRONIDAZOLE GALDERMA LABS LP Manufacturing (CMC) Approval
09/04/2014 NOVOLOG MIX 50/50
BLA #021810		 SUPPL-8 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
09/04/2014 LATISSE
NDA #022369		 SUPPL-8 BIMATOPROST ABBVIE Labeling Approval
09/04/2014 LATISSE
NDA #022369		 SUPPL-10 BIMATOPROST ABBVIE Efficacy Approval
09/04/2014 PRADAXA
NDA #022512		 SUPPL-25 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
09/04/2014 SOTALOL HYDROCHLORIDE
ANDA #075429		 SUPPL-14 SOTALOL HYDROCHLORIDE TEVA Labeling Approval
09/04/2014 TRANDOLAPRIL
ANDA #078508		 SUPPL-2 TRANDOLAPRIL EPIC PHARMA Manufacturing (CMC) Approval
09/04/2014 KEYTRUDA
BLA #125514		 ORIG-1 PEMBROLIZUMAB MERCK SHARP DOHME Approval
09/04/2014 DOXERCALCIFEROL
ANDA #200926		 SUPPL-1 DOXERCALCIFEROL CAPLIN Manufacturing (CMC) Approval
09/04/2014 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202867		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE LUPIN Approval
09/04/2014 ZOLEDRONIC ACID
ANDA #202923		 ORIG-1 ZOLEDRONIC ACID USV Approval
09/04/2014 OXYCODONE HYDROCHLORIDE
ANDA #203208		 SUPPL-1 OXYCODONE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
09/04/2014 OXYCODONE HYDROCHLORIDE
ANDA #204037		 SUPPL-2 OXYCODONE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
09/04/2014 EPANED KIT
NDA #204308		 SUPPL-2 ENALAPRIL MALEATE AZURITY Efficacy Approval
09/04/2014 EPANED KIT
NDA #204308		 SUPPL-3 ENALAPRIL MALEATE AZURITY Efficacy Approval
09/04/2014 LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ
NDA #206040		 ORIG-1 LAMIVUDINE;ZIDOVUDINE;EFAVIRENZ MYLAN LABS LTD Type 4 - New Combination Tentative Approval
09/04/2014 ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE
NDA #206041		 ORIG-1 ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE MYLAN LABS LTD Type 4 - New Combination Tentative Approval
09/05/2014 CEREZYME
BLA #020367		 SUPPL-91 IMIGLUCERASE GENZYME Approval
09/05/2014 LANTUS
BLA #021081		 SUPPL-61 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
09/05/2014 LANTUS SOLOSTAR
BLA #021081		 SUPPL-61 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
09/05/2014 MUCINEX DM
NDA #021620		 SUPPL-36 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN RECKITT BENCKISER Manufacturing (CMC) Approval
09/05/2014 BESIVANCE
NDA #022308		 SUPPL-9 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
09/05/2014 FENTANYL-100
ANDA #076709		 SUPPL-21 FENTANYL ACTAVIS LABS UT INC Manufacturing (CMC) Approval
09/05/2014 FENTANYL-25
ANDA #076709		 SUPPL-21 FENTANYL ACTAVIS LABS UT INC Manufacturing (CMC) Approval
09/05/2014 FENTANYL-50
ANDA #076709		 SUPPL-21 FENTANYL ACTAVIS LABS UT INC Manufacturing (CMC) Approval
09/05/2014 FENTANYL-75
ANDA #076709		 SUPPL-21 FENTANYL ACTAVIS LABS UT INC Manufacturing (CMC) Approval
09/05/2014 CAMPATH
BLA #103948		 SUPPL-5150 ALEMTUZUMAB GENZYME Approval
09/05/2014 LEMTRADA
BLA #103948		 SUPPL-5150 ALEMTUZUMAB GENZYME Approval
09/05/2014 PEGASYS
BLA #103964		 SUPPL-5261 PEGINTERFERON ALFA-2A Pharmaand GmbH Approval
09/05/2014 MIRVASO
NDA #204708		 SUPPL-1 BRIMONIDINE TARTRATE GALDERMA LABS LP Manufacturing (CMC) Approval
09/05/2014 OLYSIO
NDA #205123		 SUPPL-3 SIMEPREVIR SODIUM JANSSEN PRODS Labeling Approval
09/05/2014 AURYXIA
NDA #205874		 ORIG-1 FERRIC CITRATE KERYX BIOPHARMS Type 5 - New Formulation or New Manufacturer Approval
09/06/2014 SOLU-CORTEF
NDA #009866		 SUPPL-92 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
09/08/2014 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016366		 SUPPL-212 SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017585		 SUPPL-140 DEXTROSE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #017607		 SUPPL-153 DEXTROSE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #017608		 SUPPL-137 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017610		 SUPPL-119 DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #017641		 SUPPL-159 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #018080		 SUPPL-115 DEXTROSE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018090		 SUPPL-114 SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 RINGER'S IN PLASTIC CONTAINER
NDA #018251		 SUPPL-89 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018362		 SUPPL-95 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018362		 SUPPL-95 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018362		 SUPPL-95 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018362		 SUPPL-95 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018362		 SUPPL-95 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018362		 SUPPL-95 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018371		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018371		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018371		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-35 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/08/2014 SODIUM CHLORIDE 0.9%
NDA #019635		 SUPPL-35 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/08/2014 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-35 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/08/2014 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-35 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/08/2014 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-35 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019686		 SUPPL-29 POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019686		 SUPPL-29 POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019691		 SUPPL-34 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019691		 SUPPL-34 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019691		 SUPPL-34 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019691		 SUPPL-34 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019691		 SUPPL-34 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019691		 SUPPL-34 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/08/2014 VELCADE
NDA #021602		 SUPPL-39 BORTEZOMIB TAKEDA PHARMS USA Manufacturing (CMC) Approval
09/08/2014 BONIVA
NDA #021858		 SUPPL-17 IBANDRONATE SODIUM ROCHE Manufacturing (CMC) Approval
09/08/2014 PRIMSOL
NDA #074973		 SUPPL-7 TRIMETHOPRIM HYDROCHLORIDE PANGEA Manufacturing (CMC) Approval
09/08/2014 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA Approval
09/08/2014 KALBITOR
BLA #125277		 SUPPL-71 ECALLANTIDE DYAX CORP. Approval
09/08/2014 NITROFURANTOIN
ANDA #201693		 ORIG-1 NITROFURANTOIN NOVEL LABS INC Approval
09/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #203711		 ORIG-1 ONDANSETRON HYDROCHLORIDE QILU PHARM HAINAN Approval
09/08/2014 TRINTELLIX
NDA #204447		 SUPPL-4 VORTIOXETINE HYDROBROMIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
09/09/2014 ULTRATAG
NDA #019981		 SUPPL-9 TECHNETIUM TC-99M RED BLOOD CELL KIT CURIUM Manufacturing (CMC) Approval
09/09/2014 UNITHROID
NDA #021210		 SUPPL-9 LEVOTHYROXINE SODIUM STEVENS J Manufacturing (CMC) Approval
09/09/2014 ARGATROBAN IN SODIUM CHLORIDE
NDA #022434		 SUPPL-6 ARGATROBAN CIPLA Labeling Approval
09/09/2014 NAMENDA XR
NDA #022525		 SUPPL-7 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
09/09/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-3 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ACS DOBFAR SPA Labeling Approval
09/09/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-4 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ACS DOBFAR SPA Labeling Approval
09/09/2014 LOVASTATIN
ANDA #075828		 SUPPL-24 LOVASTATIN ACTAVIS ELIZABETH Labeling Approval
09/09/2014 RISPERIDONE
ANDA #076904		 SUPPL-5 RISPERIDONE HIKMA Labeling Approval
09/09/2014 RISPERIDONE
ANDA #076904		 SUPPL-6 RISPERIDONE HIKMA Labeling Approval
09/09/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #090498		 SUPPL-5 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ACS DOBFAR SPA Labeling Approval
09/09/2014 TACROLIMUS
ANDA #200744		 ORIG-1 TACROLIMUS FOUGERA PHARMS INC Approval
09/09/2014 ICLUSIG
NDA #203469		 SUPPL-12 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
09/09/2014 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE SCIEGEN PHARMS Approval
09/10/2014 OXYTOCIN
NDA #018248		 SUPPL-42 OXYTOCIN FRESENIUS KABI USA Manufacturing (CMC) Approval
09/10/2014 MUCINEX
NDA #021282		 SUPPL-44 GUAIFENESIN RECKITT BENCKISER Manufacturing (CMC) Approval
09/10/2014 EMSAM
NDA #021336		 SUPPL-5 SELEGILINE SOMERSET Labeling Approval
09/10/2014 EMSAM
NDA #021336		 SUPPL-10 SELEGILINE SOMERSET Efficacy Approval
09/10/2014 NIFEDIPINE
ANDA #077899		 SUPPL-9 NIFEDIPINE PH HEALTH Labeling Approval
09/10/2014 CONTRAVE
NDA #200063		 ORIG-1 BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE AZURITY Type 4 - New Combination Approval
09/10/2014 FAMCICLOVIR
ANDA #202438		 ORIG-1 FAMCICLOVIR HETERO LABS LTD V Approval
09/10/2014 MONTELUKAST SODIUM
ANDA #202843		 ORIG-1 MONTELUKAST SODIUM HETERO LABS LTD V Approval
09/10/2014 PANTOPRAZOLE SODIUM
ANDA #202882		 ORIG-1 PANTOPRAZOLE SODIUM HETERO LABS LTD V Approval
09/10/2014 XTANDI
NDA #203415		 SUPPL-3 ENZALUTAMIDE ASTELLAS Efficacy Approval
09/10/2014 OXYCODONE HYDROCHLORIDE
ANDA #204085		 ORIG-1 OXYCODONE HYDROCHLORIDE CHARTWELL MOLECULAR Approval
09/11/2014 MICRONOR
NDA #016954		 SUPPL-107 NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
09/11/2014 MODICON 28
NDA #017735		 SUPPL-116 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
09/11/2014 ORTHO-NOVUM 1/35-28
NDA #017919		 SUPPL-98 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
09/11/2014 ORTHO-NOVUM 7/7/7-21
NDA #018985		 SUPPL-62 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
09/11/2014 ORTHO-NOVUM 7/7/7-28
NDA #018985		 SUPPL-62 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
09/11/2014 HECTOROL
NDA #021027		 SUPPL-30 DOXERCALCIFEROL SANOFI Manufacturing (CMC) Approval
09/11/2014 ARGATROBAN IN SODIUM CHLORIDE
NDA #022485		 SUPPL-2 ARGATROBAN PLANO PHARMS Manufacturing (CMC) Approval
09/11/2014 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070765		 SUPPL-21 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE TP ANDA HOLDINGS Labeling Approval
09/11/2014 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070766		 SUPPL-17 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE TP ANDA HOLDINGS Labeling Approval
09/11/2014 TRAZODONE HYDROCHLORIDE
ANDA #071196		 SUPPL-64 TRAZODONE HYDROCHLORIDE APOTEX INC Labeling Approval
09/11/2014 TRAZODONE HYDROCHLORIDE
ANDA #071258		 SUPPL-41 TRAZODONE HYDROCHLORIDE APOTEX Labeling Approval
09/11/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075525		 SUPPL-1 FLUOXETINE HYDROCHLORIDE SCIEGEN PHARMS Labeling Approval
09/11/2014 DOXEPIN HYDROCHLORIDE
ANDA #075924		 SUPPL-2 DOXEPIN HYDROCHLORIDE PHARM ASSOC Labeling Approval
09/11/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076015		 SUPPL-11 FLUOXETINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
09/11/2014 RIBAVIRIN
ANDA #077094		 SUPPL-7 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
09/11/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #081048		 SUPPL-31 IMIPRAMINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
09/11/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #081049		 SUPPL-34 IMIPRAMINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
09/11/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #081050		 SUPPL-34 IMIPRAMINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
09/11/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #088262		 SUPPL-34 IMIPRAMINE HYDROCHLORIDE STRIDES PHARMA INTL Labeling Approval
09/11/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #088276		 SUPPL-34 IMIPRAMINE HYDROCHLORIDE STRIDES PHARMA INTL Labeling Approval
09/11/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #088292		 SUPPL-34 IMIPRAMINE HYDROCHLORIDE STRIDES PHARMA INTL Labeling Approval
09/11/2014 HYDRALAZINE HYDROCHLORIDE
ANDA #088468		 SUPPL-37 HYDRALAZINE HYDROCHLORIDE PLIVA Manufacturing (CMC) Approval
09/11/2014 HYDRALAZINE HYDROCHLORIDE
ANDA #089097		 SUPPL-33 HYDRALAZINE HYDROCHLORIDE PLIVA Manufacturing (CMC) Approval
09/11/2014 HYDRALAZINE HYDROCHLORIDE
ANDA #089098		 SUPPL-32 HYDRALAZINE HYDROCHLORIDE PLIVA Manufacturing (CMC) Approval
09/11/2014 LEVALBUTEROL HYDROCHLORIDE
ANDA #200875		 ORIG-1 LEVALBUTEROL HYDROCHLORIDE TEVA PARENTERAL Approval
09/11/2014 DORZOLAMIDE HYDROCHLORIDE
ANDA #202053		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE REGCON HOLDINGS Approval
09/11/2014 OPCICON ONE-STEP
ANDA #202635		 ORIG-1 LEVONORGESTREL SUN PHARM Approval
09/11/2014 MONTELUKAST SODIUM
ANDA #203366		 ORIG-1 MONTELUKAST SODIUM MACLEODS PHARMS Approval
09/12/2014 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #016784		 SUPPL-35 GLYCINE B BRAUN Manufacturing (CMC) Approval
09/12/2014 AN-SULFUR COLLOID
NDA #017858		 SUPPL-39 TECHNETIUM TC-99M SULFUR COLLOID KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
09/12/2014 HUMULIN N
BLA #018781		 SUPPL-150 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
09/12/2014 HUMATROPE
BLA #019640		 SUPPL-97 SOMATROPIN LILLY Approval
09/12/2014 HUMULIN 70/30
BLA #019717		 SUPPL-129 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
09/12/2014 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-129 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
09/12/2014 ZOLOFT
NDA #019839		 SUPPL-84 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
09/12/2014 NAPRELAN
NDA #020353		 SUPPL-30 NAPROXEN SODIUM TWI PHARMS Manufacturing (CMC) Approval
09/12/2014 ADVIL LIQUI-GELS
NDA #020402		 SUPPL-39 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
09/12/2014 ADVIL MIGRAINE LIQUI-GELS
NDA #020402		 SUPPL-39 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
09/12/2014 HUMALOG
BLA #020563		 SUPPL-152 INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-152 INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG PEN
BLA #020563		 SUPPL-152 INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-152 INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 THALOMID
NDA #020785		 SUPPL-54 THALIDOMIDE BRISTOL-MYERS REMS Approval
09/12/2014 ALLEGRA ALLERGY
NDA #020872		 SUPPL-32 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
09/12/2014 ALLEGRA HIVES
NDA #020872		 SUPPL-32 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
09/12/2014 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-32 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
09/12/2014 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-32 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
09/12/2014 ZOLOFT
NDA #020990		 SUPPL-43 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
09/12/2014 HUMALOG MIX 75/25
BLA #021017		 SUPPL-103 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-103 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-103 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG MIX 50/50
BLA #021018		 SUPPL-96 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-96 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-96 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
09/12/2014 FORTEO
NDA #021318		 SUPPL-41 TERIPARATIDE LILLY Manufacturing (CMC) Approval
09/12/2014 REVLIMID
NDA #021880		 SUPPL-39 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
09/12/2014 REVLIMID
NDA #021880		 SUPPL-40 LENALIDOMIDE BRISTOL MYERS SQUIBB Labeling Approval
09/12/2014 AFINITOR
NDA #022334		 SUPPL-26 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
09/12/2014 VIBRAMYCIN
NDA #050006		 SUPPL-86 DOXYCYCLINE PFIZER Labeling Approval
09/12/2014 VIBRAMYCIN
NDA #050007		 SUPPL-27 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
09/12/2014 VIBRAMYCIN
NDA #050480		 SUPPL-52 DOXYCYCLINE CALCIUM PFIZER Labeling Approval
09/12/2014 VIBRA-TABS
NDA #050533		 SUPPL-42 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
09/12/2014 MYCOPHENOLATE MOFETIL
ANDA #065410		 SUPPL-5 MYCOPHENOLATE MOFETIL HIKMA Manufacturing (CMC) Approval
09/12/2014 MYCOPHENOLATE MOFETIL
ANDA #065413		 SUPPL-6 MYCOPHENOLATE MOFETIL HIKMA Manufacturing (CMC) Approval
09/12/2014 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #065443		 SUPPL-4 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE MYLAN PHARMS INC Manufacturing (CMC) Approval
09/12/2014 LEVETIRACETAM
ANDA #077319		 SUPPL-5 LEVETIRACETAM OXFORD PHARMS Labeling Approval
09/12/2014 EVEKEO
ANDA #200166		 SUPPL-2 AMPHETAMINE SULFATE AZURITY Labeling Approval
09/12/2014 DAPTOMYCIN
ANDA #202857		 ORIG-1 DAPTOMYCIN HOSPIRA Approval
09/12/2014 POMALYST
NDA #204026		 SUPPL-4 POMALIDOMIDE BRISTOL REMS Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-5 DIVALPROEX SODIUM TEVA Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-7 DIVALPROEX SODIUM TEVA Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-8 DIVALPROEX SODIUM TEVA Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-9 DIVALPROEX SODIUM TEVA Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-11 DIVALPROEX SODIUM TEVA Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-3 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-5 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-6 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-12 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-13 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077567		 SUPPL-8 DIVALPROEX SODIUM MYLAN Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077567		 SUPPL-9 DIVALPROEX SODIUM MYLAN Labeling Approval
09/13/2014 DIVALPROEX SODIUM
ANDA #077567		 SUPPL-10 DIVALPROEX SODIUM MYLAN Labeling Approval
09/14/2014 BUPROPION HYDROCHLORIDE
ANDA #075491		 SUPPL-28 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
09/14/2014 GRANISETRON HYDROCHLORIDE
ANDA #078629		 SUPPL-6 GRANISETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
09/15/2014 TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-44 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-44 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-44 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 AMINOSYN II 10% IN PLASTIC CONTAINER
NDA #020015		 SUPPL-33 AMINO ACIDS OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-24 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-22 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/15/2014 METHYLIN
NDA #021419		 SUPPL-8 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
09/15/2014 METHYLIN
NDA #021475		 SUPPL-8 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
09/15/2014 CLOLAR
NDA #021673		 SUPPL-23 CLOFARABINE GENZYME Labeling Approval
09/15/2014 MEMBRANEBLUE
NDA #022278		 SUPPL-3 TRYPAN BLUE DORC Labeling Approval
09/15/2014 XARELTO
NDA #022406		 SUPPL-11 RIVAROXABAN JANSSEN PHARMS Manufacturing (CMC) Approval
09/15/2014 CENTANY
NDA #050788		 SUPPL-4 MUPIROCIN PADAGIS US Manufacturing (CMC) Approval
09/15/2014 ENALAPRIL MALEATE
ANDA #075501		 SUPPL-6 ENALAPRIL MALEATE WATSON LABS Labeling Approval
09/15/2014 ENALAPRIL MALEATE
ANDA #075501		 SUPPL-7 ENALAPRIL MALEATE WATSON LABS Labeling Approval
09/15/2014 ESCITALOPRAM OXALATE
ANDA #079062		 SUPPL-3 ESCITALOPRAM OXALATE AUROBINDO PHARMA LTD Labeling Approval
09/15/2014 ESCITALOPRAM OXALATE
ANDA #090432		 SUPPL-8 ESCITALOPRAM OXALATE AUROBINDO PHARMA LTD Labeling Approval
09/15/2014 SETLAKIN
ANDA #090716		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL NOVAST LABS Approval
09/15/2014 GRANISETRON HYDROCHLORIDE
ANDA #091136		 SUPPL-7 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
09/15/2014 GRANISETRON HYDROCHLORIDE
ANDA #091137		 SUPPL-8 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
09/15/2014 ADENOSINE
ANDA #202313		 ORIG-1 ADENOSINE AVET LIFESCIENCES Approval
09/15/2014 IRBESARTAN
ANDA #203081		 SUPPL-6 IRBESARTAN AUROBINDO PHARMA LTD Labeling Approval
09/15/2014 AMOXICILLIN
ANDA #204030		 ORIG-1 AMOXICILLIN AUROBINDO PHARMA LTD Approval
09/15/2014 CLOPIDOGREL BISULFATE
ANDA #204165		 ORIG-1 CLOPIDOGREL BISULFATE SCIEGEN PHARMS Approval
09/16/2014 TEGRETOL
NDA #016608		 SUPPL-99 CARBAMAZEPINE NOVARTIS Labeling Approval
09/16/2014 TEGRETOL
NDA #018281		 SUPPL-47 CARBAMAZEPINE NOVARTIS Labeling Approval
09/16/2014 TEGRETOL
NDA #018927		 SUPPL-40 CARBAMAZEPINE NOVARTIS Labeling Approval
09/16/2014 TEGRETOL-XR
NDA #020234		 SUPPL-30 CARBAMAZEPINE NOVARTIS Labeling Approval
09/16/2014 FORTICAL
NDA #021406		 SUPPL-24 CALCITONIN SALMON RECOMBINANT UPSHER SMITH LABS Manufacturing (CMC) Approval
09/16/2014 AMBISOME
NDA #050740		 SUPPL-23 AMPHOTERICIN B ASTELLAS Manufacturing (CMC) Approval
09/16/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076922		 SUPPL-8 FLUOXETINE HYDROCHLORIDE STRIDES PHARMA INTL Labeling Approval
09/16/2014 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-4 DIVALPROEX SODIUM APOTEX Labeling Approval
09/16/2014 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-5 DIVALPROEX SODIUM APOTEX Labeling Approval
09/16/2014 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-6 DIVALPROEX SODIUM APOTEX Labeling Approval
09/16/2014 NICARDIPINE HYDROCHLORIDE
NDA #078405		 SUPPL-6 NICARDIPINE HYDROCHLORIDE SUN PHARM Labeling Approval
09/16/2014 COMPLERA
NDA #202123		 SUPPL-18 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
09/16/2014 MOVANTIK
NDA #204760		 ORIG-1 NALOXEGOL OXALATE AVERITAS Type 1 - New Molecular Entity Approval
09/16/2014 VARITHENA
NDA #205098		 SUPPL-2 POLIDOCANOL BOSTON SCITFC Manufacturing (CMC) Approval
09/16/2014 TOBRAMYCIN SULFATE
ANDA #205179		 ORIG-1 TOBRAMYCIN SULFATE EPIC PHARMA LLC Approval
09/16/2014 TOBRAMYCIN SULFATE
ANDA #205685		 ORIG-1 TOBRAMYCIN SULFATE XELLIA PHARMS APS Approval
09/17/2014 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016366		 SUPPL-201 SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/17/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #017641		 SUPPL-150 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/17/2014 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018090		 SUPPL-105 SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/17/2014 SEROSTIM
BLA #020604		 SUPPL-80 SOMATROPIN EMD SERONO Approval
09/17/2014 SEROSTIM LQ
BLA #020604		 SUPPL-80 SOMATROPIN EMD SERONO Approval
09/17/2014 DALIRESP
NDA #022522		 SUPPL-4 ROFLUMILAST ASTRAZENECA Manufacturing (CMC) Approval
09/17/2014 CLARITHROMYCIN
ANDA #065266		 SUPPL-2 CLARITHROMYCIN WOCKHARDT Labeling Approval
09/17/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-9 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ACS DOBFAR SPA Labeling Approval
09/17/2014 CARVEDILOL
ANDA #078384		 SUPPL-2 CARVEDILOL REGCON HOLDINGS Manufacturing (CMC) Approval
09/17/2014 STENDRA
NDA #202276		 SUPPL-5 AVANAFIL VIVUS LLC Efficacy Approval
09/17/2014 DOCETAXEL
NDA #203551		 SUPPL-2 DOCETAXEL ACTAVIS Labeling Approval
09/18/2014 HALCION
NDA #017892		 SUPPL-47 TRIAZOLAM PFIZER Labeling Approval
09/18/2014 BILTRICIDE
NDA #018714		 SUPPL-14 PRAZIQUANTEL BAYER HLTHCARE Manufacturing (CMC) Approval
09/18/2014 ZOFRAN
NDA #020007		 SUPPL-46 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/18/2014 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-46 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/18/2014 ZOFRAN
NDA #020103		 SUPPL-34 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/18/2014 ZOFRAN
NDA #020605		 SUPPL-18 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/18/2014 ANZEMET
NDA #020623		 SUPPL-12 DOLASETRON MESYLATE VALIDUS PHARMS Labeling Approval
09/18/2014 ANZEMET
NDA #020624		 SUPPL-25 DOLASETRON MESYLATE VALIDUS PHARMS Labeling Approval
09/18/2014 ZOFRAN ODT
NDA #020781		 SUPPL-18 ONDANSETRON SANDOZ Labeling Approval
09/18/2014 ALOXI
NDA #021372		 SUPPL-20 PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
09/18/2014 MEGACE ES
NDA #021778		 SUPPL-18 MEGESTROL ACETATE ENDO OPERATIONS Labeling Approval
09/18/2014 SANCUSO
NDA #022198		 SUPPL-12 GRANISETRON APOTEX Labeling Approval
09/18/2014 ALOXI
NDA #022233		 SUPPL-5 PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
09/18/2014 ZUPLENZ
NDA #022524		 SUPPL-3 ONDANSETRON AQUESTIVE Labeling Approval
09/18/2014 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-30 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
09/18/2014 CEFAZOLIN AND DEXTROSE
NDA #050779		 SUPPL-23 CEFAZOLIN SODIUM B BRAUN Efficacy Approval
09/18/2014 GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077165		 SUPPL-10 GRANISETRON HYDROCHLORIDE DR REDDYS Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #077177		 SUPPL-1 GRANISETRON HYDROCHLORIDE HIKMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #077186		 SUPPL-5 GRANISETRON HYDROCHLORIDE HIKMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #077187		 SUPPL-5 GRANISETRON HYDROCHLORIDE HIKMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #077297		 SUPPL-16 GRANISETRON HYDROCHLORIDE DR REDDYS Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #077842		 SUPPL-12 GRANISETRON HYDROCHLORIDE HIKMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #077913		 SUPPL-5 GRANISETRON HYDROCHLORIDE HIKMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #077963		 SUPPL-16 GRANISETRON HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078037		 SUPPL-2 GRANISETRON HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078080		 SUPPL-5 GRANISETRON HYDROCHLORIDE TEVA PHARMS Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078090		 SUPPL-5 GRANISETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078096		 SUPPL-5 GRANISETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078101		 SUPPL-8 LEVETIRACETAM TEVA PHARMS Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078101		 SUPPL-10 LEVETIRACETAM TEVA PHARMS Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078101		 SUPPL-11 LEVETIRACETAM TEVA PHARMS Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078106		 SUPPL-6 LEVETIRACETAM PRINSTON INC Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078106		 SUPPL-9 LEVETIRACETAM PRINSTON INC Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078106		 SUPPL-10 LEVETIRACETAM PRINSTON INC Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078221		 SUPPL-3 GRANISETRON HYDROCHLORIDE BARR Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078260		 SUPPL-1 GRANISETRON HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078262		 SUPPL-1 GRANISETRON HYDROCHLORIDE AMNEAL Labeling Approval
09/18/2014 GRANISOL
ANDA #078334		 SUPPL-4 GRANISETRON HYDROCHLORIDE INTRA SANA LABS Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078392		 SUPPL-17 GRANISETRON HYDROCHLORIDE DR REDDYS Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078522		 SUPPL-5 GRANISETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078531		 SUPPL-2 GRANISETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078534		 SUPPL-2 GRANISETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078564		 SUPPL-1 GRANISETRON HYDROCHLORIDE WOCKHARDT USA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078565		 SUPPL-1 GRANISETRON HYDROCHLORIDE WOCKHARDT USA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078566		 SUPPL-1 GRANISETRON HYDROCHLORIDE WOCKHARDT USA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078629		 SUPPL-7 GRANISETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078678		 SUPPL-3 GRANISETRON HYDROCHLORIDE ORBION PHARMS Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078725		 SUPPL-5 GRANISETRON HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078808		 SUPPL-11 GRANISETRON HYDROCHLORIDE SANDOZ Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078835		 SUPPL-12 GRANISETRON HYDROCHLORIDE SANDOZ INC Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078843		 SUPPL-3 GRANISETRON HYDROCHLORIDE APOTEX INC Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078846		 SUPPL-2 GRANISETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078858		 SUPPL-13 LEVETIRACETAM TORRENT PHARMS Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078858		 SUPPL-16 LEVETIRACETAM TORRENT PHARMS Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078858		 SUPPL-18 LEVETIRACETAM TORRENT PHARMS Labeling Approval
09/18/2014 LEVETIRACETAM
ANDA #078858		 SUPPL-19 LEVETIRACETAM TORRENT PHARMS Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078863		 SUPPL-1 GRANISETRON HYDROCHLORIDE BIONPHARMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078863		 SUPPL-1 GRANISETRON HYDROCHLORIDE BIONPHARMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #078880		 SUPPL-1 GRANISETRON HYDROCHLORIDE BIONPHARMA Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #079078		 SUPPL-2 GRANISETRON HYDROCHLORIDE RISING Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #079119		 SUPPL-1 GRANISETRON HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #090817		 SUPPL-2 GRANISETRON HYDROCHLORIDE TARO Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #091136		 SUPPL-8 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #091137		 SUPPL-9 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
09/18/2014 GRANISETRON HYDROCHLORIDE
ANDA #091274		 SUPPL-2 GRANISETRON HYDROCHLORIDE AM REGENT Labeling Approval
09/18/2014 OFLOXACIN
ANDA #091656		 ORIG-1 OFLOXACIN CADILA PHARMS LTD Approval
09/18/2014 TRULICITY
BLA #125469		 ORIG-1 DULAGLUTIDE ELI LILLY AND CO Approval
09/18/2014 HYDRALAZINE HYDROCHLORIDE
ANDA #203845		 ORIG-1 HYDRALAZINE HYDROCHLORIDE CADILA PHARMS LTD Approval
09/18/2014 VASOSTRICT
NDA #204485		 SUPPL-1 VASOPRESSIN PH HEALTH Manufacturing (CMC) Approval
09/19/2014 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-72 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
09/19/2014 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-72 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
09/19/2014 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-72 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
09/19/2014 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-72 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
09/19/2014 MARCAINE
NDA #018692		 SUPPL-16 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
09/19/2014 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-39 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Labeling Approval
09/19/2014 TEMODAR
NDA #021029		 SUPPL-27 TEMOZOLOMIDE MERCK SHARP DOHME Manufacturing (CMC) Approval
09/19/2014 CHANTIX
NDA #021928		 SUPPL-32 VARENICLINE TARTRATE PF PRISM CV Efficacy Approval
09/19/2014 CHANTIX
NDA #021928		 SUPPL-36 VARENICLINE TARTRATE PF PRISM CV Efficacy Approval
09/19/2014 CHANTIX
NDA #021928		 SUPPL-38 VARENICLINE TARTRATE PF PRISM CV Labeling Approval
09/19/2014 LEXISCAN
NDA #022161		 SUPPL-12 REGADENOSON ASTELLAS Labeling Approval
09/19/2014 LUMIGAN
NDA #022184		 SUPPL-3 BIMATOPROST ABBVIE Manufacturing (CMC) Approval
09/19/2014 LEVOFLOXACIN
ANDA #076276		 SUPPL-4 LEVOFLOXACIN NATCO PHARMA Labeling Approval
09/19/2014 LEVOFLOXACIN
ANDA #076361		 SUPPL-8 LEVOFLOXACIN TEVA Labeling Approval
09/19/2014 LEVOFLOXACIN
ANDA #076361		 SUPPL-9 LEVOFLOXACIN TEVA Labeling Approval
09/19/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #076565		 SUPPL-4 VENLAFAXINE HYDROCHLORIDE TEVA Labeling Approval
09/19/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #076565		 SUPPL-5 VENLAFAXINE HYDROCHLORIDE TEVA Labeling Approval
09/19/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #076565		 SUPPL-6 VENLAFAXINE HYDROCHLORIDE TEVA Labeling Approval
09/19/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #076565		 SUPPL-10 VENLAFAXINE HYDROCHLORIDE TEVA Labeling Approval
09/19/2014 LEVOFLOXACIN
ANDA #076710		 SUPPL-6 LEVOFLOXACIN DR REDDYS LABS INC Labeling Approval
09/19/2014 LEVOFLOXACIN
ANDA #076710		 SUPPL-7 LEVOFLOXACIN DR REDDYS LABS INC Labeling Approval
09/19/2014 LEVOFLOXACIN
ANDA #077097		 SUPPL-4 LEVOFLOXACIN NATCO PHARMA Labeling Approval
09/19/2014 CARVEDILOL
ANDA #077316		 SUPPL-11 CARVEDILOL SCIEGEN PHARMS Labeling Approval
09/19/2014 LOSARTAN POTASSIUM
ANDA #077424		 SUPPL-6 LOSARTAN POTASSIUM CHARTWELL RX Labeling Approval
09/19/2014 CARVEDILOL
ANDA #077614		 SUPPL-6 CARVEDILOL ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 CARVEDILOL
ANDA #077614		 SUPPL-9 CARVEDILOL ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 LOSARTAN POTASSIUM
ANDA #078232		 SUPPL-22 LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
09/19/2014 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-3 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-4 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-5 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-6 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-8 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-9 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
09/19/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #078932		 SUPPL-6 VENLAFAXINE HYDROCHLORIDE ALEMBIC PHARMS LTD Labeling Approval
09/19/2014 AMLODIPINE BESYLATE
ANDA #201380		 SUPPL-2 AMLODIPINE BESYLATE GRAVITI PHARMS Labeling Approval
09/19/2014 JANUMET XR
NDA #202270		 SUPPL-8 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Manufacturing (CMC) Approval
09/19/2014 RIZATRIPTAN BENZOATE
ANDA #203146		 ORIG-1 RIZATRIPTAN BENZOATE MACLEODS PHARMS LTD Approval
09/19/2014 PENTOSTATIN
ANDA #203554		 ORIG-1 PENTOSTATIN RISING Approval
09/19/2014 AMMONIA N 13
ANDA #204366		 ORIG-1 AMMONIA N-13 SHERTECH LABS LLC Approval
09/19/2014 OTEZLA
NDA #205437		 SUPPL-3 APREMILAST AMGEN INC Manufacturing (CMC) Approval
09/20/2014 CEFTIN
NDA #050605		 SUPPL-43 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
09/20/2014 CEFTIN
NDA #050605		 SUPPL-46 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
09/20/2014 CEFTIN
NDA #050672		 SUPPL-29 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
09/20/2014 CEFTIN
NDA #050672		 SUPPL-32 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
09/21/2014 DOXYCYCLINE
ANDA #065053		 SUPPL-18 DOXYCYCLINE SUN PHARM INDS LTD Labeling Approval
09/21/2014 DOXAZOSIN MESYLATE
ANDA #075580		 SUPPL-19 DOXAZOSIN MESYLATE APOTEX Labeling Approval
09/21/2014 DOXAZOSIN MESYLATE
ANDA #075580		 SUPPL-20 DOXAZOSIN MESYLATE APOTEX Labeling Approval
09/21/2014 AMLODIPINE BESYLATE
ANDA #076418		 SUPPL-16 AMLODIPINE BESYLATE MYLAN Labeling Approval
09/21/2014 FINASTERIDE
ANDA #076436		 SUPPL-7 FINASTERIDE DR REDDYS LABS INC Labeling Approval
09/21/2014 LOSARTAN POTASSIUM
ANDA #076958		 SUPPL-9 LOSARTAN POTASSIUM TEVA Labeling Approval
09/21/2014 LOSARTAN POTASSIUM
ANDA #076958		 SUPPL-11 LOSARTAN POTASSIUM TEVA Labeling Approval
09/21/2014 AMLODIPINE BESYLATE
ANDA #077974		 SUPPL-2 AMLODIPINE BESYLATE SUN PHARM INDS LTD Labeling Approval
09/21/2014 LOSARTAN POTASSIUM
ANDA #078243		 SUPPL-14 LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
09/21/2014 LOSARTAN POTASSIUM
ANDA #078243		 SUPPL-16 LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
09/21/2014 CARVEDILOL
ANDA #078332		 SUPPL-5 CARVEDILOL AUROBINDO PHARMA Labeling Approval
09/21/2014 CARVEDILOL
ANDA #078332		 SUPPL-10 CARVEDILOL AUROBINDO PHARMA Labeling Approval
09/21/2014 CARVEDILOL
ANDA #078332		 SUPPL-12 CARVEDILOL AUROBINDO PHARMA Labeling Approval
09/21/2014 CARVEDILOL
ANDA #078332		 SUPPL-14 CARVEDILOL AUROBINDO PHARMA Labeling Approval
09/21/2014 LEVETIRACETAM
ANDA #078869		 SUPPL-1 LEVETIRACETAM NOVAX Labeling Approval
09/21/2014 LEVETIRACETAM
ANDA #078869		 SUPPL-2 LEVETIRACETAM NOVAX Labeling Approval
09/21/2014 AMLODIPINE BESYLATE
ANDA #078925		 SUPPL-5 AMLODIPINE BESYLATE ALKEM Labeling Approval
09/21/2014 LOSARTAN POTASSIUM
ANDA #090083		 SUPPL-10 LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
09/22/2014 METHADONE HYDROCHLORIDE
NDA #006383		 SUPPL-15 METHADONE HYDROCHLORIDE MALLINCKRODT INC Manufacturing (CMC) Approval
09/22/2014 BREVITAL SODIUM
NDA #011559		 SUPPL-47 METHOHEXITAL SODIUM PH HEALTH Manufacturing (CMC) Approval
09/22/2014 METHADOSE
NDA #017116		 SUPPL-27 METHADONE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
09/22/2014 RENOVA
NDA #021108		 SUPPL-16 TRETINOIN VALEANT PHARMS NORTH Manufacturing (CMC) Approval
09/22/2014 FUZEON
NDA #021481		 SUPPL-21 ENFUVIRTIDE ROCHE Manufacturing (CMC) Approval
09/22/2014 SEASONIQUE
NDA #021840		 SUPPL-10 ETHINYL ESTRADIOL; LEVONORGESTREL TEVA BRANDED PHARM Manufacturing (CMC) Approval
09/22/2014 SPIRONOLACTONE
ANDA #040353		 SUPPL-35 SPIRONOLACTONE ACTAVIS ELIZABETH Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #040750		 SUPPL-7 SPIRONOLACTONE OXFORD PHARMS Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #040750		 SUPPL-12 SPIRONOLACTONE OXFORD PHARMS Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #040750		 SUPPL-15 SPIRONOLACTONE OXFORD PHARMS Labeling Approval
09/22/2014 BENZACLIN
NDA #050756		 SUPPL-43 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
09/22/2014 CLINDESSE
NDA #050793		 SUPPL-19 CLINDAMYCIN PHOSPHATE PADAGIS US Manufacturing (CMC) Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065063		 SUPPL-32 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065063		 SUPPL-34 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065063		 SUPPL-35 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065064		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065064		 SUPPL-32 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065064		 SUPPL-34 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065065		 SUPPL-26 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065065		 SUPPL-29 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065065		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065066		 SUPPL-29 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065066		 SUPPL-32 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065066		 SUPPL-34 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065189		 SUPPL-14 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065189		 SUPPL-15 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065189		 SUPPL-16 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
09/22/2014 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #072801		 SUPPL-36 METOCLOPRAMIDE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
09/22/2014 DOXAZOSIN MESYLATE
ANDA #075509		 SUPPL-17 DOXAZOSIN MESYLATE AUROBINDO PHARMA USA Labeling Approval
09/22/2014 CARVEDILOL
ANDA #078332		 SUPPL-8 CARVEDILOL AUROBINDO PHARMA Labeling Approval
09/22/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #078865		 SUPPL-2 VENLAFAXINE HYDROCHLORIDE SCIEGEN PHARMS Labeling Approval
09/22/2014 PYRIDOXINE HYDROCHLORIDE
ANDA #080618		 SUPPL-31 PYRIDOXINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #086809		 SUPPL-65 SPIRONOLACTONE CHARTWELL RX Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #086809		 SUPPL-66 SPIRONOLACTONE CHARTWELL RX Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #086809		 SUPPL-67 SPIRONOLACTONE CHARTWELL RX Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #089424		 SUPPL-52 SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
09/22/2014 SPIRONOLACTONE
ANDA #089424		 SUPPL-53 SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
09/22/2014 LATANOPROST
ANDA #090887		 SUPPL-9 LATANOPROST EPIC PHARMA LLC Manufacturing (CMC) Approval
09/22/2014 IMIQUIMOD
ANDA #200173		 SUPPL-1 IMIQUIMOD TARO Manufacturing (CMC) Approval
09/22/2014 ZOHYDRO ER
NDA #202880		 SUPPL-1 HYDROCODONE BITARTRATE RECRO GAINESVILLE Manufacturing (CMC) Approval
09/22/2014 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #203058		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EPIC PHARMA LLC Approval
09/22/2014 IRBESARTAN
ANDA #203081		 SUPPL-4 IRBESARTAN AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
09/22/2014 BLOXIVERZ
NDA #204078		 SUPPL-3 NEOSTIGMINE METHYLSULFATE EXELA PHARMA Manufacturing (CMC) Approval
09/22/2014 SODIUM FLUORIDE F-18
ANDA #204315		 ORIG-1 SODIUM FLUORIDE F-18 SHERTECH LABS LLC Approval
09/23/2014 HUMULIN R
BLA #018780		 SUPPL-148 INSULIN HUMAN LILLY Approval
09/23/2014 HUMULIN R
BLA #018780		 SUPPL-148 INSULIN RECOMBINANT HUMAN LILLY Approval
09/23/2014 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-148 INSULIN HUMAN LILLY Approval
09/23/2014 HUMULIN R PEN
BLA #018780		 SUPPL-148 INSULIN RECOMBINANT HUMAN LILLY Approval
09/23/2014 BENICAR
NDA #021286		 SUPPL-32 OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
09/23/2014 BENICAR HCT
NDA #021532		 SUPPL-26 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
09/23/2014 AZOR
NDA #022100		 SUPPL-26 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
09/23/2014 TOPOTECAN HYDROCHLORIDE
NDA #022453		 SUPPL-3 TOPOTECAN HYDROCHLORIDE MEITHEAL Manufacturing (CMC) Approval
09/23/2014 SPIRONOLACTONE
ANDA #040424		 SUPPL-16 SPIRONOLACTONE MYLAN Labeling Approval
09/23/2014 SPIRONOLACTONE
ANDA #040424		 SUPPL-17 SPIRONOLACTONE MYLAN Labeling Approval
09/23/2014 ZANOSAR
NDA #050577		 SUPPL-39 STREPTOZOCIN TEVA PHARMS USA Manufacturing (CMC) Approval
09/23/2014 BENAZEPRIL HYDROCHLORIDE
ANDA #076402		 SUPPL-13 BENAZEPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
09/23/2014 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-6 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
09/23/2014 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076631		 SUPPL-16 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SANDOZ Labeling Approval
09/23/2014 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076631		 SUPPL-19 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SANDOZ Labeling Approval
09/23/2014 CILOSTAZOL
ANDA #077027		 SUPPL-7 CILOSTAZOL TEVA Labeling Approval
09/23/2014 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077483		 SUPPL-5 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SUN PHARM INDS LTD Labeling Approval
09/23/2014 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077483		 SUPPL-6 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SUN PHARM INDS LTD Labeling Approval
09/23/2014 ATORVASTATIN CALCIUM
ANDA #077575		 SUPPL-3 ATORVASTATIN CALCIUM CHARTWELL RX Labeling Approval
09/23/2014 RISPERIDONE
ANDA #077953		 SUPPL-9 RISPERIDONE APOTEX INC Labeling Approval
09/23/2014 ROPIVACAINE HYDROCHLORIDE
ANDA #090194		 ORIG-1 ROPIVACAINE HYDROCHLORIDE HOSPIRA Approval
09/23/2014 ROPIVACAINE HYDROCHLORIDE
ANDA #090318		 ORIG-1 ROPIVACAINE HYDROCHLORIDE RISING Approval
09/23/2014 ATORVASTATIN CALCIUM
ANDA #091226		 SUPPL-2 ATORVASTATIN CALCIUM MYLAN PHARMS INC Labeling Approval
09/23/2014 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091397		 SUPPL-1 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
09/23/2014 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091397		 SUPPL-5 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
09/23/2014 LEVOFLOXACIN
ANDA #091436		 SUPPL-1 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
09/23/2014 LEVOFLOXACIN
ANDA #091436		 SUPPL-3 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
09/23/2014 HUMIRA
BLA #125057		 SUPPL-356 ADALIMUMAB ABBVIE INC Approval
09/23/2014 TRIBENZOR
NDA #200175		 SUPPL-20 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
09/23/2014 OPANA ER
NDA #201655		 SUPPL-14 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Manufacturing (CMC) Approval
09/23/2014 ZELBORAF
NDA #202429		 SUPPL-7 VEMURAFENIB HOFFMANN LA ROCHE Manufacturing (CMC) Approval
09/23/2014 METHYLPHENIDATE HYDROCHLORIDE
ANDA #202892		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE OXFORD PHARMS Approval
09/23/2014 MINIVELLE
NDA #203752		 SUPPL-4 ESTRADIOL NOVEN Efficacy Approval
09/23/2014 OTEZLA
NDA #206088		 ORIG-1 APREMILAST CELGENE CORP Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
09/24/2014 XYLOCAINE VISCOUS
NDA #009470		 SUPPL-25 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/24/2014 STERILE WATER IN PLASTIC CONTAINER
NDA #017513		 SUPPL-61 STERILE WATER FOR IRRIGATION OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/24/2014 DIOVAN
NDA #020665		 SUPPL-37 VALSARTAN NOVARTIS Labeling Approval
09/24/2014 DIOVAN HCT
NDA #020818		 SUPPL-64 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
09/24/2014 FOSRENOL
NDA #021468		 SUPPL-19 LANTHANUM CARBONATE TAKEDA PHARMS USA Labeling Approval
09/24/2014 SPIRIVA RESPIMAT
NDA #021936		 ORIG-1 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Type 3 - New Dosage Form Approval
09/24/2014 EXFORGE
NDA #021990		 SUPPL-24 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Labeling Approval
09/24/2014 EXFORGE HCT
NDA #022314		 SUPPL-19 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
09/24/2014 VIBRAMYCIN
NDA #050442		 SUPPL-17 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
09/24/2014 FORTAZ
NDA #050578		 SUPPL-55 CEFTAZIDIME PAI HOLDINGS PHARM Labeling Approval
09/24/2014 FORTAZ IN PLASTIC CONTAINER
NDA #050634		 SUPPL-23 CEFTAZIDIME SODIUM PAI HOLDINGS PHARM Labeling Approval
09/24/2014 ISOSORBIDE MONONITRATE
ANDA #075155		 SUPPL-34 ISOSORBIDE MONONITRATE CHARTWELL MOLECULAR Manufacturing (CMC) Approval
09/24/2014 BUPROPION HYDROCHLORIDE
ANDA #075584		 SUPPL-36 BUPROPION HYDROCHLORIDE PHARMAZONE Labeling Approval
09/24/2014 BUPROPION HYDROCHLORIDE
ANDA #075584		 SUPPL-38 BUPROPION HYDROCHLORIDE PHARMAZONE Labeling Approval
09/24/2014 BUPROPION HYDROCHLORIDE
ANDA #075913		 SUPPL-23 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
09/24/2014 BUPROPION HYDROCHLORIDE
ANDA #075914		 SUPPL-16 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
09/24/2014 BUPROPION HYDROCHLORIDE
ANDA #075914		 SUPPL-20 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
09/24/2014 BENAZEPRIL HYDROCHLORIDE
ANDA #076118		 SUPPL-19 BENAZEPRIL HYDROCHLORIDE PRINSTON INC Labeling Approval
09/24/2014 TOPIRAMATE
ANDA #076311		 SUPPL-3 TOPIRAMATE ACCORD HLTHCARE Labeling Approval
09/24/2014 GABAPENTIN
ANDA #076877		 SUPPL-4 GABAPENTIN PHARMAZONE Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #076919		 SUPPL-8 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #076919		 SUPPL-10 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #076919		 SUPPL-11 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #076919		 SUPPL-13 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #076919		 SUPPL-14 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 BENAZEPRIL HYDROCHLORIDE
ANDA #077128		 SUPPL-8 BENAZEPRIL HYDROCHLORIDE MACLEODS PHARMS Labeling Approval
09/24/2014 BENAZEPRIL HYDROCHLORIDE
ANDA #077128		 SUPPL-9 BENAZEPRIL HYDROCHLORIDE MACLEODS PHARMS Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #077324		 SUPPL-7 LEVETIRACETAM FOSUN PHARMA Labeling Approval
09/24/2014 LEVOFLOXACIN
ANDA #077438		 SUPPL-9 LEVOFLOXACIN SANDOZ Labeling Approval
09/24/2014 LEVOFLOXACIN
ANDA #077438		 SUPPL-10 LEVOFLOXACIN SANDOZ Labeling Approval
09/24/2014 PAROXETINE HYDROCHLORIDE
ANDA #078406		 SUPPL-23 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
09/24/2014 AMLODIPINE BESYLATE
ANDA #078573		 SUPPL-13 AMLODIPINE BESYLATE TORRENT PHARMS Labeling Approval
09/24/2014 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #089534		 SUPPL-40 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
09/24/2014 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #089534		 SUPPL-41 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
09/24/2014 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090011		 SUPPL-1 AMLODIPINE BESYLATE; VALSARTAN STRIDES PHARMA INTL Labeling Approval
09/24/2014 ADENOSINE
ANDA #090212		 SUPPL-2 ADENOSINE MYLAN ASI Manufacturing (CMC) Approval
09/24/2014 LEVETIRACETAM
ANDA #090261		 SUPPL-6 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #090261		 SUPPL-8 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #090261		 SUPPL-9 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #090261		 SUPPL-11 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVETIRACETAM
ANDA #090261		 SUPPL-12 LEVETIRACETAM MYLAN Labeling Approval
09/24/2014 LEVOFLOXACIN
ANDA #090787		 SUPPL-3 LEVOFLOXACIN APOTEX INC Labeling Approval
09/24/2014 LEVOFLOXACIN
ANDA #090787		 SUPPL-4 LEVOFLOXACIN APOTEX INC Labeling Approval
09/24/2014 RALOXIFENE HYDROCHLORIDE
ANDA #090842		 ORIG-1 RALOXIFENE HYDROCHLORIDE INVAGEN PHARMS Approval
09/24/2014 CAPECITABINE
ANDA #091649		 SUPPL-1 CAPECITABINE TEVA PHARMS USA Manufacturing (CMC) Approval
09/24/2014 ARMODAFINIL
ANDA #200152		 ORIG-1 ARMODAFINIL TEVA PHARMS USA INC Tentative Approval
09/24/2014 BENZONATATE
ANDA #201209		 ORIG-1 BENZONATATE THEPHARMANETWORK LLC Approval
09/24/2014 VITEKTA
NDA #203093		 ORIG-1 ELVITEGRAVIR GILEAD SCIENCES INC Type 5 - New Formulation or New Manufacturer Approval
09/24/2014 TYBOST
NDA #203094		 ORIG-1 COBICISTAT GILEAD SCIENCES INC Type 5 - New Formulation or New Manufacturer Approval
09/24/2014 TYBOST
NDA #203094		 ORIG-2 COBICISTAT GILEAD SCIENCES INC Efficacy Approval
09/24/2014 NAFTIN
NDA #204286		 SUPPL-2 NAFTIFINE HYDROCHLORIDE LEGACY Manufacturing (CMC) Approval
09/24/2014 FOSRENOL
NDA #204734		 ORIG-1 LANTHANUM CARBONATE TAKEDA PHARMS USA Type 3 - New Dosage Form Approval
09/24/2014 VELPHORO
NDA #205109		 SUPPL-1 FERRIC OXYHYDROXIDE VIFOR FRESENIUS Labeling Approval
09/25/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/25/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/25/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/25/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/25/2014 BETOPTIC
NDA #019270		 SUPPL-34 BETAXOLOL HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
09/25/2014 PREMARIN
NDA #020216		 SUPPL-78 ESTROGENS, CONJUGATED WYETH PHARMS Manufacturing (CMC) Approval
09/25/2014 GENOTROPIN
BLA #020280		 SUPPL-77 SOMATROPIN PHARMACIA Approval
09/25/2014 GENOTROPIN PRESERVATIVE FREE
BLA #020280		 SUPPL-77 SOMATROPIN PHARMACIA Approval
09/25/2014 TIMOLOL MALEATE
NDA #020963		 SUPPL-12 TIMOLOL MALEATE SANDOZ Manufacturing (CMC) Approval
09/25/2014 NORDITROPIN
BLA #021148		 SUPPL-41 SOMATROPIN NOVO NORDISK INC Approval
09/25/2014 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-41 SOMATROPIN NOVO NORDISK INC Approval
09/25/2014 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-41 SOMATROPIN NOVO NORDISK INC Approval
09/25/2014 QOLIANA
NDA #021764		 SUPPL-6 BRIMONIDINE TARTRATE SANDOZ Manufacturing (CMC) Approval
09/25/2014 BROVANA
NDA #021912		 SUPPL-24 ARFORMOTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
09/25/2014 TASIGNA
NDA #022068		 SUPPL-19 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
09/25/2014 MITOSOL
NDA #022572		 SUPPL-3 MITOMYCIN GLAUKOS Labeling Approval
09/25/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #040805		 SUPPL-1 HYDROXYZINE HYDROCHLORIDE HETERO LABS LTD III Labeling Approval
09/25/2014 ZINACEF
NDA #050558		 SUPPL-69 CEFUROXIME SODIUM PAI HOLDINGS PHARM Labeling Approval
09/25/2014 ZINACEF IN PLASTIC CONTAINER
NDA #050643		 SUPPL-22 CEFUROXIME SODIUM PAI HOLDINGS PHARM Labeling Approval
09/25/2014 CLEOCIN
ANDA #062644		 SUPPL-21 CLINDAMYCIN PALMITATE HYDROCHLORIDE PFIZER Labeling Approval
09/25/2014 CLEOCIN
ANDA #062644		 SUPPL-22 CLINDAMYCIN PALMITATE HYDROCHLORIDE PFIZER Labeling Approval
09/25/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065093		 SUPPL-17 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
09/25/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065098		 SUPPL-11 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
09/25/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065098		 SUPPL-12 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
09/25/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065117		 SUPPL-18 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
09/25/2014 GABAPENTIN
ANDA #076017		 SUPPL-37 GABAPENTIN IVAX SUB TEVA PHARMS Labeling Approval
09/25/2014 ACETAMINOPHEN
ANDA #076200		 SUPPL-19 ACETAMINOPHEN OHM LABS Labeling Approval
09/25/2014 ACETAMINOPHEN
ANDA #076200		 SUPPL-20 ACETAMINOPHEN OHM LABS Labeling Approval
09/25/2014 ACETAMINOPHEN
ANDA #076200		 SUPPL-21 ACETAMINOPHEN OHM LABS Labeling Approval
09/25/2014 QUINAPRIL HYDROCHLORIDE
ANDA #076240		 SUPPL-9 QUINAPRIL HYDROCHLORIDE APOTEX INC Labeling Approval
09/25/2014 QUINAPRIL HYDROCHLORIDE
ANDA #076240		 SUPPL-10 QUINAPRIL HYDROCHLORIDE APOTEX INC Labeling Approval
09/25/2014 QUINAPRIL HYDROCHLORIDE
ANDA #076240		 SUPPL-11 QUINAPRIL HYDROCHLORIDE APOTEX INC Labeling Approval
09/25/2014 RAMIPRIL
ANDA #076549		 SUPPL-15 RAMIPRIL WATSON LABS Labeling Approval
09/25/2014 QUINAPRIL HYDROCHLORIDE
ANDA #076803		 SUPPL-2 QUINAPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
09/25/2014 QUINAPRIL HYDROCHLORIDE
ANDA #076803		 SUPPL-3 QUINAPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
09/25/2014 AMLODIPINE BESYLATE
ANDA #077262		 SUPPL-4 AMLODIPINE BESYLATE HIKMA Labeling Approval
09/25/2014 RAMIPRIL
ANDA #077470		 SUPPL-6 RAMIPRIL TEVA PHARMS Labeling Approval
09/25/2014 RAMIPRIL
ANDA #077470		 SUPPL-7 RAMIPRIL TEVA PHARMS Labeling Approval
09/25/2014 RAMIPRIL
ANDA #077470		 SUPPL-8 RAMIPRIL TEVA PHARMS Labeling Approval
09/25/2014 RAMIPRIL
ANDA #077470		 SUPPL-9 RAMIPRIL TEVA PHARMS Labeling Approval
09/25/2014 RAMIPRIL
ANDA #077470		 SUPPL-10 RAMIPRIL TEVA PHARMS Labeling Approval
09/25/2014 LEVOFLOXACIN
ANDA #077652		 SUPPL-2 LEVOFLOXACIN ZYDUS LIFESCIENCES Labeling Approval
09/25/2014 LEVOFLOXACIN
ANDA #077652		 SUPPL-3 LEVOFLOXACIN ZYDUS LIFESCIENCES Labeling Approval
09/25/2014 RISPERIDONE
ANDA #078040		 SUPPL-14 RISPERIDONE ZYDUS PHARMS USA INC Labeling Approval
09/25/2014 CARVEDILOL
ANDA #078165		 SUPPL-7 CARVEDILOL RUBICON RESEARCH Labeling Approval
09/25/2014 RISPERIDONE
ANDA #078269		 SUPPL-11 RISPERIDONE RISING Labeling Approval
09/25/2014 RISPERIDONE
ANDA #078707		 SUPPL-12 RISPERIDONE RENATA Labeling Approval
09/25/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #087329		 SUPPL-20 HYDROXYZINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/25/2014 LOSARTAN POTASSIUM
ANDA #090428		 SUPPL-7 LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
09/25/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #090498		 SUPPL-3 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ACS DOBFAR SPA Manufacturing (CMC) Approval
09/25/2014 LOSARTAN POTASSIUM
ANDA #090544		 SUPPL-1 LOSARTAN POTASSIUM AIPING PHARM INC Labeling Approval
09/25/2014 LEVETIRACETAM
ANDA #090981		 SUPPL-2 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
09/25/2014 MINOCYCLINE HYDROCHLORIDE
ANDA #091118		 ORIG-1 MINOCYCLINE HYDROCHLORIDE SUN PHARM INDS LTD Approval
09/25/2014 TELMISARTAN
ANDA #202130		 SUPPL-1 TELMISARTAN ALEMBIC Labeling Approval
09/25/2014 GABAPENTIN
ANDA #202764		 SUPPL-4 GABAPENTIN INVAGEN PHARMS Labeling Approval
09/25/2014 UCERIS
NDA #203634		 SUPPL-2 BUDESONIDE SALIX Manufacturing (CMC) Approval
09/25/2014 FLUDEOXYGLUCOSE F18
ANDA #204333		 ORIG-1 FLUDEOXYGLUCOSE F-18 MA GENERAL HOSP Approval
09/25/2014 PHENTERMINE HYDROCHLORIDE
ANDA #205008		 ORIG-1 PHENTERMINE HYDROCHLORIDE NUVO PHARM Approval
09/25/2014 PHENTERMINE HYDROCHLORIDE
ANDA #205017		 ORIG-1 PHENTERMINE HYDROCHLORIDE NUVO PHARM Approval
09/26/2014 DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #016687		 SUPPL-103 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #016689		 SUPPL-106 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 LOESTRIN FE 1/20
NDA #017354		 SUPPL-47 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
09/26/2014 AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
NDA #017865		 SUPPL-48 GLYCINE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 STERILE WATER IN PLASTIC CONTAINER
NDA #017866		 SUPPL-53 STERILE WATER FOR IRRIGATION BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 LOESTRIN 21 1.5/30
NDA #017875		 SUPPL-34 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
09/26/2014 LOESTRIN 21 1/20
NDA #017876		 SUPPL-33 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
09/26/2014 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-71 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #018494		 SUPPL-27 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 ACETIC ACID 0.25% IN PLASTIC CONTAINER
NDA #018523		 SUPPL-22 ACETIC ACID, GLACIAL BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
NDA #018632		 SUPPL-50 STERILE WATER FOR INJECTION BAXTER HLTHCARE Manufacturing (CMC) Approval
09/26/2014 ALLOPURINOL
NDA #018832		 SUPPL-48 ALLOPURINOL WATSON LABS Manufacturing (CMC) Approval
09/26/2014 ALLOPURINOL
NDA #018832		 SUPPL-55 ALLOPURINOL WATSON LABS Manufacturing (CMC) Approval
09/26/2014 ZYRTEC ALLERGY
NDA #019835		 SUPPL-34 CETIRIZINE HYDROCHLORIDE KENVUE BRANDS Manufacturing (CMC) Approval
09/26/2014 ZYRTEC HIVES
NDA #019835		 SUPPL-34 CETIRIZINE HYDROCHLORIDE KENVUE BRANDS Manufacturing (CMC) Approval
09/26/2014 TAGAMET HB
NDA #020238		 SUPPL-20 CIMETIDINE MEDTECH PRODUCTS Manufacturing (CMC) Approval
09/26/2014 PROTONIX IV
NDA #020988		 SUPPL-49 PANTOPRAZOLE SODIUM WYETH PHARMS Manufacturing (CMC) Approval
09/26/2014 PROTONIX IV
NDA #020988		 SUPPL-50 PANTOPRAZOLE SODIUM WYETH PHARMS Manufacturing (CMC) Approval
09/26/2014 DIOVAN
NDA #021283		 SUPPL-44 VALSARTAN NOVARTIS Labeling Approval
09/26/2014 ELIDEL
NDA #021302		 SUPPL-20 PIMECROLIMUS BAUSCH Manufacturing (CMC) Approval
09/26/2014 HICON
NDA #021305		 SUPPL-35 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
09/26/2014 SODIUM IODIDE I 131
NDA #021305		 SUPPL-35 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
09/26/2014 CUBICIN
NDA #021572		 SUPPL-45 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
09/26/2014 CUBICIN RF
NDA #021572		 SUPPL-45 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
09/26/2014 LETAIRIS
NDA #022081		 SUPPL-28 AMBRISENTAN GILEAD Manufacturing (CMC) Approval
09/26/2014 FIRMAGON
NDA #022201		 SUPPL-5 DEGARELIX ACETATE FERRING Manufacturing (CMC) Approval
09/26/2014 ZENPEP
BLA #022210		 SUPPL-11 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) EURAND PHARMA LTD Approval
09/26/2014 OZURDEX
NDA #022315		 SUPPL-10 DEXAMETHASONE ABBVIE Labeling Approval
09/26/2014 ZUTRIPRO
NDA #022439		 SUPPL-7 CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE PERSION Manufacturing (CMC) Approval
09/26/2014 NAMENDA XR
NDA #022525		 SUPPL-6 MEMANTINE HYDROCHLORIDE ABBVIE Labeling Approval
09/26/2014 QSYMIA
NDA #022580		 SUPPL-10 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC REMS Approval
09/26/2014 QSYMIA
NDA #022580		 SUPPL-11 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Labeling Approval
09/26/2014 QSYMIA
NDA #022580		 SUPPL-12 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Labeling Approval
09/26/2014 PFIZERPEN
ANDA #060657		 SUPPL-21 PENICILLIN G POTASSIUM PFIZER Labeling Approval
09/26/2014 DOXYCYCLINE
ANDA #065055		 SUPPL-15 DOXYCYCLINE STRIDES PHARMA INTL Labeling Approval
09/26/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065089		 SUPPL-17 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Labeling Approval
09/26/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065096		 SUPPL-29 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Labeling Approval
09/26/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065101		 SUPPL-28 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Labeling Approval
09/26/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065205		 SUPPL-17 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Labeling Approval
09/26/2014 CLOZAPINE
ANDA #074949		 SUPPL-44 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076388		 SUPPL-21 LAMOTRIGINE TEVA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076388		 SUPPL-23 LAMOTRIGINE TEVA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076388		 SUPPL-24 LAMOTRIGINE TEVA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076420		 SUPPL-12 LAMOTRIGINE TEVA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076420		 SUPPL-14 LAMOTRIGINE TEVA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076420		 SUPPL-15 LAMOTRIGINE TEVA Labeling Approval
09/26/2014 FINASTERIDE
ANDA #076511		 SUPPL-18 FINASTERIDE TEVA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076708		 SUPPL-7 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
09/26/2014 CLOZAPINE
ANDA #076809		 SUPPL-4 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
09/26/2014 CLOZAPINE
ANDA #076809		 SUPPL-7 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #076928		 SUPPL-14 LAMOTRIGINE WATSON LABS Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077004		 SUPPL-1 RAMIPRIL CIPLA Labeling Approval
09/26/2014 CITALOPRAM HYDROBROMIDE
ANDA #077031		 SUPPL-29 CITALOPRAM HYDROBROMIDE AUROBINDO Labeling Approval
09/26/2014 CITALOPRAM HYDROBROMIDE
ANDA #077031		 SUPPL-30 CITALOPRAM HYDROBROMIDE AUROBINDO Labeling Approval
09/26/2014 AMLODIPINE BESYLATE
ANDA #077073		 SUPPL-2 AMLODIPINE BESYLATE CIPLA Labeling Approval
09/26/2014 LOSARTAN POTASSIUM
ANDA #077459		 SUPPL-8 LOSARTAN POTASSIUM HIKMA Labeling Approval
09/26/2014 FINASTERIDE
ANDA #077578		 SUPPL-13 FINASTERIDE MYLAN Labeling Approval
09/26/2014 FINASTERIDE
ANDA #077578		 SUPPL-14 FINASTERIDE MYLAN Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077626		 SUPPL-9 RAMIPRIL LUPIN Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077626		 SUPPL-13 RAMIPRIL LUPIN Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077626		 SUPPL-14 RAMIPRIL LUPIN Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077626		 SUPPL-15 RAMIPRIL LUPIN Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #077633		 SUPPL-9 LAMOTRIGINE ZYDUS PHARMS USA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #077633		 SUPPL-12 LAMOTRIGINE ZYDUS PHARMS USA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #077633		 SUPPL-16 LAMOTRIGINE ZYDUS PHARMS USA Labeling Approval
09/26/2014 QUINAPRIL HYDROCHLORIDE
ANDA #077690		 SUPPL-22 QUINAPRIL HYDROCHLORIDE LUPIN Labeling Approval
09/26/2014 QUINAPRIL HYDROCHLORIDE
ANDA #077690		 SUPPL-24 QUINAPRIL HYDROCHLORIDE LUPIN Labeling Approval
09/26/2014 QUINAPRIL HYDROCHLORIDE
ANDA #077690		 SUPPL-25 QUINAPRIL HYDROCHLORIDE LUPIN Labeling Approval
09/26/2014 AMLODIPINE BESYLATE
ANDA #077759		 SUPPL-8 AMLODIPINE BESYLATE SCIEGEN PHARMS Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077900		 SUPPL-5 RAMIPRIL HIKMA Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077900		 SUPPL-6 RAMIPRIL HIKMA Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077900		 SUPPL-7 RAMIPRIL HIKMA Manufacturing (CMC) Approval
09/26/2014 RAMIPRIL
ANDA #077900		 SUPPL-9 RAMIPRIL HIKMA Labeling Approval
09/26/2014 RAMIPRIL
ANDA #077900		 SUPPL-10 RAMIPRIL HIKMA Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #078009		 SUPPL-10 LAMOTRIGINE ZYDUS PHARMS USA INC Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #078009		 SUPPL-12 LAMOTRIGINE ZYDUS PHARMS USA INC Labeling Approval
09/26/2014 LAMOTRIGINE
ANDA #078009		 SUPPL-15 LAMOTRIGINE ZYDUS PHARMS USA INC Labeling Approval
09/26/2014 AMLODIPINE BESYLATE
ANDA #078021		 SUPPL-9 AMLODIPINE BESYLATE AUROBINDO PHARMA Labeling Approval
09/26/2014 AMLODIPINE BESYLATE
ANDA #078043		 SUPPL-15 AMLODIPINE BESYLATE LUPIN Labeling Approval
09/26/2014 FLUOXETINE HYDROCHLORIDE
ANDA #078143		 SUPPL-2 FLUOXETINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078154		 SUPPL-15 LEVETIRACETAM LUPIN Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078154		 SUPPL-19 LEVETIRACETAM LUPIN Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078191		 SUPPL-3 RAMIPRIL PHARMAZONE Labeling Approval
09/26/2014 GRANISETRON HYDROCHLORIDE
ANDA #078197		 SUPPL-1 GRANISETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
09/26/2014 GRANISETRON HYDROCHLORIDE
ANDA #078198		 SUPPL-2 GRANISETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
09/26/2014 CARVEDILOL
ANDA #078251		 SUPPL-11 CARVEDILOL GLENMARK PHARMS LTD Labeling Approval
09/26/2014 AMLODIPINE BESYLATE
ANDA #078477		 SUPPL-16 AMLODIPINE BESYLATE AMNEAL PHARMS NY Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078745		 SUPPL-3 RAMIPRIL CHARTWELL MOLECULAR Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078745		 SUPPL-5 RAMIPRIL CHARTWELL MOLECULAR Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078745		 SUPPL-7 RAMIPRIL CHARTWELL MOLECULAR Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078832		 SUPPL-4 RAMIPRIL ZYDUS PHARMS USA Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078832		 SUPPL-6 RAMIPRIL ZYDUS PHARMS USA Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078832		 SUPPL-7 RAMIPRIL ZYDUS PHARMS USA Labeling Approval
09/26/2014 RAMIPRIL
ANDA #078832		 SUPPL-9 RAMIPRIL ZYDUS PHARMS USA Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078976		 SUPPL-6 LEVETIRACETAM ACTAVIS MID ATLANTIC Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078976		 SUPPL-9 LEVETIRACETAM ACTAVIS MID ATLANTIC Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078976		 SUPPL-11 LEVETIRACETAM ACTAVIS MID ATLANTIC Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078976		 SUPPL-13 LEVETIRACETAM ACTAVIS MID ATLANTIC Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078993		 SUPPL-8 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078993		 SUPPL-9 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #078993		 SUPPL-10 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
09/26/2014 RISPERIDONE
ANDA #079088		 SUPPL-15 RISPERIDONE TORRENT PHARMS Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #090025		 SUPPL-15 LEVETIRACETAM LUPIN Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #090025		 SUPPL-19 LEVETIRACETAM LUPIN Labeling Approval
09/26/2014 DULOXETINE HYDROCHLORIDE
ANDA #090739		 SUPPL-3 DULOXETINE HYDROCHLORIDE ZYDUS HLTHCARE Labeling Approval
09/26/2014 DULOXETINE HYDROCHLORIDE
ANDA #090739		 SUPPL-4 DULOXETINE HYDROCHLORIDE ZYDUS HLTHCARE Labeling Approval
09/26/2014 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-4 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/26/2014 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-5 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #091093		 SUPPL-3 LEVETIRACETAM ACTAVIS LABS FL INC Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #091261		 SUPPL-3 LEVETIRACETAM APOTEX INC Labeling Approval
09/26/2014 LEVETIRACETAM
ANDA #091261		 SUPPL-4 LEVETIRACETAM APOTEX INC Labeling Approval
09/26/2014 XOLAIR
BLA #103976		 SUPPL-5161 OMALIZUMAB GENENTECH Approval
09/26/2014 ILUVIEN
NDA #201923		 ORIG-1 FLUOCINOLONE ACETONIDE ALIMERA SCIENCES INC Type 3 - New Dosage Form Approval
09/26/2014 TELMISARTAN
ANDA #202397		 SUPPL-1 TELMISARTAN MYLAN Labeling Approval
09/26/2014 QUINAPRIL HYDROCHLORIDE
ANDA #202725		 SUPPL-2 QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/26/2014 QUINAPRIL HYDROCHLORIDE
ANDA #202725		 SUPPL-3 QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/26/2014 MEKINIST
NDA #204114		 SUPPL-3 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Manufacturing (CMC) Approval
09/26/2014 MITIGARE
NDA #204820		 ORIG-1 COLCHICINE HIKMA Type 3 - New Dosage Form Approval
09/29/2014 SKELAXIN
NDA #013217		 SUPPL-56 METAXALONE KING PHARMS Manufacturing (CMC) Approval
09/29/2014 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016730		 SUPPL-52 DEXTROSE B BRAUN Manufacturing (CMC) Approval
09/29/2014 CORTROSYN
NDA #016750		 SUPPL-28 COSYNTROPIN AMPHASTAR PHARMS INC Manufacturing (CMC) Approval
09/29/2014 ZOVIRAX
NDA #018604		 SUPPL-25 ACYCLOVIR BAUSCH Manufacturing (CMC) Approval
09/29/2014 SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
NDA #019319		 SUPPL-15 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/29/2014 CLOZARIL
NDA #019758		 SUPPL-72 CLOZAPINE HERITAGE LIFE Labeling Approval
09/29/2014 COZAAR
NDA #020386		 SUPPL-61 LOSARTAN POTASSIUM ORGANON Labeling Approval
09/29/2014 LUMIGAN
NDA #021275		 SUPPL-26 BIMATOPROST ABBVIE Labeling Approval
09/29/2014 ALINIA
NDA #021498		 SUPPL-7 NITAZOXANIDE ROMARK Manufacturing (CMC) Approval
09/29/2014 RELISTOR
NDA #021964		 SUPPL-10 METHYLNALTREXONE BROMIDE SALIX PHARMS Efficacy Approval
09/29/2014 FLO-PRED
NDA #022067		 SUPPL-11 PREDNISOLONE ACETATE SUN PHARMA CANADA Manufacturing (CMC) Approval
09/29/2014 ZINGO
NDA #022114		 SUPPL-3 LIDOCAINE HYDROCHLORIDE POWDER PHARMS Manufacturing (CMC) Approval
09/29/2014 VOLTAREN ARTHRITIS PAIN
NDA #022122		 SUPPL-8 DICLOFENAC SODIUM HALEON US HOLDINGS Manufacturing (CMC) Approval
09/29/2014 FLUDARABINE PHOSPHATE
NDA #022137		 SUPPL-10 FLUDARABINE PHOSPHATE CAPLIN ONE LABS Manufacturing (CMC) Approval
09/29/2014 LUMIGAN
NDA #022184		 SUPPL-5 BIMATOPROST ABBVIE Labeling Approval
09/29/2014 NEXTERONE
NDA #022325		 SUPPL-10 AMIODARONE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/29/2014 ABILIFY MAINTENA KIT
NDA #202971		 SUPPL-4 ARIPIPRAZOLE OTSUKA PHARM CO LTD Manufacturing (CMC) Approval
09/29/2014 VERSACLOZ
NDA #203479		 SUPPL-5 CLOZAPINE DOUGLAS PHARMS Manufacturing (CMC) Approval
09/30/2014 GUANIDINE HYDROCHLORIDE
NDA #001546		 SUPPL-21 GUANIDINE HYDROCHLORIDE MERCK SHARP DOHME Manufacturing (CMC) Approval
09/30/2014 MESTINON
NDA #015193		 SUPPL-23 PYRIDOSTIGMINE BROMIDE BAUSCH Manufacturing (CMC) Approval
09/30/2014 LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016679		 SUPPL-109 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #016682		 SUPPL-110 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 RINGER'S IN PLASTIC CONTAINER
NDA #016693		 SUPPL-97 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 SURMONTIL
NDA #016792		 SUPPL-36 TRIMIPRAMINE MALEATE TEVA WOMENS Manufacturing (CMC) Approval
09/30/2014 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-117 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 K-TAB
NDA #018279		 SUPPL-30 POTASSIUM CHLORIDE ABBVIE Manufacturing (CMC) Approval
09/30/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #018494		 SUPPL-26 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 RINGER'S IN PLASTIC CONTAINER
NDA #018495		 SUPPL-23 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 HUMULIN N
BLA #018781		 SUPPL-120 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
09/30/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #018921		 SUPPL-34 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLOZARIL
NDA #019758		 SUPPL-64 CLOZAPINE HERITAGE LIFE Manufacturing (CMC) Approval
09/30/2014 SAIZEN
BLA #019764		 SUPPL-73 SOMATROPIN EMD SERONO Approval
09/30/2014 PROMETRIUM
NDA #019781		 SUPPL-20 PROGESTERONE ACERTIS PHARMS Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-24 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-24 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-24 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
09/30/2014 HYZAAR
NDA #020387		 SUPPL-60 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ORGANON Labeling Approval
09/30/2014 PYRIDOSTIGMINE BROMIDE
NDA #020414		 SUPPL-3 PYRIDOSTIGMINE BROMIDE US ARMY Manufacturing (CMC) Approval
09/30/2014 REMERON
NDA #020415		 SUPPL-28 MIRTAZAPINE ORGANON Manufacturing (CMC) Approval
09/30/2014 SEROSTIM
BLA #020604		 SUPPL-81 SOMATROPIN EMD SERONO Approval
09/30/2014 SEROSTIM LQ
BLA #020604		 SUPPL-81 SOMATROPIN EMD SERONO Approval
09/30/2014 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-29 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 TASMAR
NDA #020697		 SUPPL-18 TOLCAPONE BAUSCH Manufacturing (CMC) Approval
09/30/2014 PROMETRIUM
NDA #020843		 SUPPL-14 PROGESTERONE VIRTUS PHARMS Manufacturing (CMC) Approval
09/30/2014 FROVA
NDA #021006		 SUPPL-18 FROVATRIPTAN SUCCINATE ENDO OPERATIONS Manufacturing (CMC) Approval
09/30/2014 YASMIN
NDA #021098		 SUPPL-25 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 REMERON SOLTAB
NDA #021208		 SUPPL-18 MIRTAZAPINE ORGANON USA ORGANON Manufacturing (CMC) Approval
09/30/2014 ZYPREXA
NDA #021253		 SUPPL-44 OLANZAPINE CHEPLAPHARM Manufacturing (CMC) Approval
09/30/2014 INVANZ
NDA #021337		 SUPPL-42 ERTAPENEM SODIUM MSD SUB MERCK Labeling Approval
09/30/2014 ZETIA
NDA #021445		 SUPPL-37 EZETIMIBE ORGANON Labeling Approval
09/30/2014 YAZ
NDA #021676		 SUPPL-16 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
09/30/2014 VYTORIN
NDA #021687		 SUPPL-51 EZETIMIBE; SIMVASTATIN ORGANON Labeling Approval
09/30/2014 CAMBIA
NDA #022165		 SUPPL-8 DICLOFENAC POTASSIUM COSETTE Manufacturing (CMC) Approval
09/30/2014 AMPYRA
NDA #022250		 SUPPL-1 DALFAMPRIDINE MERZ Manufacturing (CMC) Approval
09/30/2014 DIFFERIN
NDA #022502		 SUPPL-5 ADAPALENE GALDERMA LABS LP Manufacturing (CMC) Approval
09/30/2014 LAZANDA
NDA #022569		 SUPPL-21 FENTANYL CITRATE BTCP PHARMA Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN '250'
NDA #050564		 SUPPL-57 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN '500'
NDA #050564		 SUPPL-57 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN '125'
NDA #050575		 SUPPL-44 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN '250'
NDA #050575		 SUPPL-44 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AZACTAM
NDA #050580		 SUPPL-43 AZTREONAM LABS DELBERT Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN '875'
NDA #050720		 SUPPL-31 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN '200'
NDA #050725		 SUPPL-32 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN '400'
NDA #050725		 SUPPL-32 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AMOXIL
NDA #050754		 SUPPL-18 AMOXICILLIN US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN ES-600
NDA #050755		 SUPPL-21 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 AUGMENTIN XR
NDA #050785		 SUPPL-16 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
09/30/2014 OMEGA-3-ACID ETHYL ESTERS
ANDA #090973		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS APOTEX Approval
09/30/2014 HUMIRA
BLA #125057		 SUPPL-367 ADALIMUMAB ABBVIE INC Approval
09/30/2014 NULOJIX
BLA #125288		 SUPPL-62 BELATACEPT BRISTOL MYERS SQUIBB Approval
09/30/2014 TOBI PODHALER
NDA #201688		 SUPPL-3 TOBRAMYCIN VIATRIS Manufacturing (CMC) Approval
09/30/2014 NORTHERA
NDA #203202		 SUPPL-2 DROXIDOPA LUNDBECK NA LTD Manufacturing (CMC) Approval
09/30/2014 BLOXIVERZ
NDA #204078		 SUPPL-5 NEOSTIGMINE METHYLSULFATE EXELA PHARMA Manufacturing (CMC) Approval
09/30/2014 TRINTELLIX
NDA #204447		 SUPPL-3 VORTIOXETINE HYDROBROMIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
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