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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 2013

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 July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/01/2013 NEURONTIN
NDA #020235		 SUPPL-54 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 NEURONTIN
NDA #020235		 SUPPL-55 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 NEURONTIN
NDA #020235		 SUPPL-56 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 ARIMIDEX
NDA #020541		 SUPPL-27 ANASTROZOLE ANI PHARMS Labeling Approval
05/01/2013 NEURONTIN
NDA #020882		 SUPPL-38 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 NEURONTIN
NDA #020882		 SUPPL-39 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 NEURONTIN
NDA #020882		 SUPPL-40 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 NEURONTIN
NDA #021129		 SUPPL-35 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 NEURONTIN
NDA #021129		 SUPPL-36 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 NEURONTIN
NDA #021129		 SUPPL-37 GABAPENTIN VIATRIS Labeling Approval
05/01/2013 LOESTRIN 24 FE
NDA #021871		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
05/01/2013 HORIZANT
NDA #022399		 SUPPL-8 GABAPENTIN ENACARBIL AZURITY Labeling Approval
05/01/2013 MYFORTIC
NDA #050791		 SUPPL-12 MYCOPHENOLATE SODIUM NOVARTIS Labeling Approval
05/01/2013 MYFORTIC
NDA #050791		 SUPPL-16 MYCOPHENOLATE SODIUM NOVARTIS Manufacturing (CMC) Approval
05/01/2013 BACITRACIN
ANDA #061212		 SUPPL-12 BACITRACIN PADAGIS US Manufacturing (CMC) Approval
05/01/2013 HEPARIN SODIUM
ANDA #088100		 SUPPL-37 HEPARIN SODIUM HOSPIRA Labeling Approval
05/01/2013 HEPARIN SODIUM
ANDA #090808		 SUPPL-9 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
05/02/2013 CARDENE
NDA #019734		 SUPPL-20 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/02/2013 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-20 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/02/2013 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-20 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/02/2013 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-20 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/02/2013 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-20 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/02/2013 SUSTIVA
NDA #020972		 SUPPL-43 EFAVIRENZ BRISTOL MYERS SQUIBB Efficacy Approval
05/02/2013 SUSTIVA
NDA #021360		 SUPPL-31 EFAVIRENZ BRISTOL MYERS SQUIBB Efficacy Approval
05/02/2013 SAMSCA
NDA #022275		 SUPPL-11 TOLVAPTAN OTSUKA Labeling Approval
05/02/2013 CARISOPRODOL
ANDA #040792		 SUPPL-4 CARISOPRODOL AUROBINDO PHARMA Labeling Approval
05/02/2013 NEORAL
NDA #050715		 SUPPL-33 CYCLOSPORINE NOVARTIS Labeling Approval
05/02/2013 NEORAL
NDA #050716		 SUPPL-34 CYCLOSPORINE NOVARTIS Labeling Approval
05/02/2013 AMOXICILLIN
ANDA #065056		 SUPPL-17 AMOXICILLIN TEVA Labeling Approval
05/02/2013 AMLODIPINE BESYLATE
ANDA #076846		 SUPPL-13 AMLODIPINE BESYLATE TEVA Manufacturing (CMC) Approval
05/02/2013 LANSOPRAZOLE
ANDA #091269		 SUPPL-4 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
05/03/2013 PROTOPAM CHLORIDE
NDA #014134		 SUPPL-34 PRALIDOXIME CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
05/03/2013 LOCOID
NDA #018652		 SUPPL-9 HYDROCORTISONE BUTYRATE PRECISION DERMAT Manufacturing (CMC) Approval
05/03/2013 LOCOID
NDA #019116		 SUPPL-8 HYDROCORTISONE BUTYRATE BAUSCH Manufacturing (CMC) Approval
05/03/2013 CONCERTA
NDA #021121		 SUPPL-29 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
05/03/2013 ZYVOX
NDA #021130		 SUPPL-23 LINEZOLID PFIZER Labeling Approval
05/03/2013 ZYVOX
NDA #021130		 SUPPL-24 LINEZOLID PFIZER Labeling Approval
05/03/2013 ZYVOX
NDA #021131		 SUPPL-21 LINEZOLID PFIZER Labeling Approval
05/03/2013 ZYVOX
NDA #021131		 SUPPL-22 LINEZOLID PFIZER Labeling Approval
05/03/2013 ZYVOX
NDA #021132		 SUPPL-22 LINEZOLID PFIZER Labeling Approval
05/03/2013 ZYVOX
NDA #021132		 SUPPL-23 LINEZOLID PFIZER Labeling Approval
05/03/2013 CANASA
NDA #021252		 SUPPL-16 MESALAMINE ABBVIE Manufacturing (CMC) Approval
05/03/2013 SANDIMMUNE
NDA #050573		 SUPPL-39 CYCLOSPORINE NOVARTIS Labeling Approval
05/03/2013 SANDIMMUNE
NDA #050574		 SUPPL-47 CYCLOSPORINE NOVARTIS Labeling Approval
05/03/2013 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-39 CEFOTAXIME SODIUM STERIMAX Manufacturing (CMC) Approval
05/03/2013 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-39 CEFOTAXIME SODIUM STERIMAX Manufacturing (CMC) Approval
05/03/2013 SANDIMMUNE
NDA #050625		 SUPPL-53 CYCLOSPORINE NOVARTIS Labeling Approval
05/03/2013 ALENDRONATE SODIUM
ANDA #076984		 SUPPL-8 ALENDRONATE SODIUM WATSON LABS Labeling Approval
05/03/2013 PANTOPRAZOLE SODIUM
ANDA #077056		 SUPPL-10 PANTOPRAZOLE SODIUM TEVA Labeling Approval
05/03/2013 CANDESARTAN CILEXETIL
ANDA #078702		 ORIG-1 CANDESARTAN CILEXETIL MYLAN Approval
05/03/2013 PROMETH VC W/ CODEINE
ANDA #088764		 SUPPL-81 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/03/2013 LIPTRUZET
NDA #200153		 ORIG-1 ATORVASTATIN CALCIUM; EZETIMIBE ORGANON Type 2 New Active Ingredient and Type 4 New Combination Approval
05/03/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #200770		 ORIG-1 HYDRALAZINE HYDROCHLORIDE STRIDES PHARMA Approval
05/03/2013 TUDORZA PRESSAIR
NDA #202450		 SUPPL-1 ACLIDINIUM BROMIDE AZURITY Manufacturing (CMC) Approval
05/03/2013 STRIBILD
NDA #203100		 SUPPL-2 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
05/03/2013 XELJANZ
NDA #203214		 SUPPL-1 TOFACITINIB CITRATE PF PRISM CV Manufacturing (CMC) Approval
05/06/2013 HALDOL
NDA #015923		 SUPPL-89 HALOPERIDOL LACTATE JANSSEN PHARMS Labeling Approval
05/06/2013 HALDOL
NDA #018701		 SUPPL-65 HALOPERIDOL DECANOATE JANSSEN PHARMS Labeling Approval
05/06/2013 OPTIMARK
NDA #020937		 SUPPL-20 GADOVERSETAMIDE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/06/2013 METADATE CD
NDA #021259		 SUPPL-23 METHYLPHENIDATE HYDROCHLORIDE LANNETT Labeling Approval
05/06/2013 METADATE CD
NDA #021259		 SUPPL-24 METHYLPHENIDATE HYDROCHLORIDE LANNETT Labeling Approval
05/06/2013 AVINZA
NDA #021260		 SUPPL-17 MORPHINE SULFATE KING PHARMS LLC Labeling Approval
05/06/2013 RITALIN LA
NDA #021284		 SUPPL-20 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
05/06/2013 DACOGEN
NDA #021790		 SUPPL-16 DECITABINE OTSUKA Manufacturing (CMC) Approval
05/06/2013 VIDAZA
NDA #050794		 SUPPL-25 AZACITIDINE BRISTOL-MYERS Manufacturing (CMC) Approval
05/06/2013 TORSEMIDE
ANDA #076894		 SUPPL-8 TORSEMIDE COREPHARMA Labeling Approval
05/06/2013 CALCITRIOL
ANDA #078066		 SUPPL-1 CALCITRIOL LONG GROVE PHARMS Labeling Approval
05/06/2013 HEPARIN SODIUM
ANDA #088100		 SUPPL-38 HEPARIN SODIUM HOSPIRA Labeling Approval
05/06/2013 HEPARIN SODIUM PRESERVATIVE FREE
ANDA #089522		 SUPPL-47 HEPARIN SODIUM HOSPIRA Labeling Approval
05/06/2013 TACROLIMUS
ANDA #090509		 SUPPL-8 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
05/06/2013 HEPARIN SODIUM
ANDA #090571		 SUPPL-11 HEPARIN SODIUM HOSPIRA INC Labeling Approval
05/06/2013 SIMPONI
BLA #125289		 SUPPL-86 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
05/06/2013 TRIBENZOR
NDA #200175		 SUPPL-13 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
05/06/2013 ALLOPURINOL
ANDA #203154		 ORIG-1 ALLOPURINOL ACCORD HLTHCARE Approval
05/07/2013 CYTOXAN
NDA #012141		 SUPPL-90 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
05/07/2013 CYTOXAN
NDA #012142		 SUPPL-112 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
05/07/2013 CYTOXAN (LYOPHILIZED)
NDA #012142		 SUPPL-112 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
05/07/2013 LYOPHILIZED CYTOXAN
NDA #012142		 SUPPL-112 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
05/07/2013 GEMZAR
NDA #020509		 SUPPL-72 GEMCITABINE HYDROCHLORIDE LILLY Labeling Approval
05/07/2013 THYROGEN
BLA #020898		 SUPPL-55 THYROTROPIN ALFA GENZYME Approval
05/07/2013 TACROLIMUS
ANDA #065461		 SUPPL-18 TACROLIMUS SANDOZ Labeling Approval
05/07/2013 VINCRISTINE SULFATE PFS
ANDA #071484		 SUPPL-41 VINCRISTINE SULFATE HOSPIRA Labeling Approval
05/07/2013 FLUVOXAMINE MALEATE
ANDA #075897		 SUPPL-23 FLUVOXAMINE MALEATE ANI PHARMS Labeling Approval
05/07/2013 CARVEDILOL
ANDA #076649		 SUPPL-8 CARVEDILOL RISING Labeling Approval
05/07/2013 CARVEDILOL
ANDA #076649		 SUPPL-9 CARVEDILOL RISING Labeling Approval
05/07/2013 CARVEDILOL
ANDA #077887		 SUPPL-3 CARVEDILOL HIKMA Labeling Approval
05/07/2013 CARVEDILOL
ANDA #077887		 SUPPL-4 CARVEDILOL HIKMA Labeling Approval
05/07/2013 CARVEDILOL
ANDA #077887		 SUPPL-6 CARVEDILOL HIKMA Labeling Approval
05/07/2013 CARVEDILOL
ANDA #078227		 SUPPL-1 CARVEDILOL SANDOZ Labeling Approval
05/07/2013 CARVEDILOL
ANDA #078227		 SUPPL-3 CARVEDILOL SANDOZ Labeling Approval
05/07/2013 CARVEDILOL
ANDA #078227		 SUPPL-5 CARVEDILOL SANDOZ Labeling Approval
05/07/2013 CARVEDILOL
ANDA #078251		 SUPPL-8 CARVEDILOL GLENMARK PHARMS LTD Labeling Approval
05/07/2013 CARVEDILOL
ANDA #078251		 SUPPL-10 CARVEDILOL GLENMARK PHARMS LTD Labeling Approval
05/07/2013 RAMIPRIL
ANDA #079116		 SUPPL-1 RAMIPRIL COREPHARMA Labeling Approval
05/07/2013 ALENDRONATE SODIUM
ANDA #090022		 SUPPL-8 ALENDRONATE SODIUM SUN PHARM Labeling Approval
05/07/2013 GEMCITABINE HYDROCHLORIDE
ANDA #091597		 ORIG-1 GEMCITABINE HYDROCHLORIDE SAGENT PHARMS Approval
05/07/2013 GEMCITABINE HYDROCHLORIDE
ANDA #202031		 ORIG-1 GEMCITABINE HYDROCHLORIDE AM REGENT Approval
05/07/2013 GEMCITABINE HYDROCHLORIDE
ANDA #202485		 ORIG-1 GEMCITABINE HYDROCHLORIDE JIANGSU HANSOH PHARM Approval
05/07/2013 ZOLEDRONIC ACID
ANDA #202571		 ORIG-1 ZOLEDRONIC ACID CHARTWELL RX Approval
05/07/2013 GEMCITABINE HYDROCHLORIDE
ANDA #202997		 ORIG-1 GEMCITABINE HYDROCHLORIDE DR REDDYS LABS LTD Approval
05/08/2013 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016733		 SUPPL-52 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/08/2013 STERILE WATER IN PLASTIC CONTAINER
NDA #016734		 SUPPL-48 STERILE WATER FOR IRRIGATION B BRAUN Manufacturing (CMC) Approval
05/08/2013 SORBITOL 3.3% IN PLASTIC CONTAINER
NDA #016741		 SUPPL-40 SORBITOL B BRAUN Manufacturing (CMC) Approval
05/08/2013 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #016784		 SUPPL-34 GLYCINE B BRAUN Manufacturing (CMC) Approval
05/08/2013 PHYSIOLYTE IN PLASTIC CONTAINER
NDA #019024		 SUPPL-21 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE B BRAUN Manufacturing (CMC) Approval
05/08/2013 CHLORHEXIDINE GLUCONATE
NDA #020111		 SUPPL-7 CHLORHEXIDINE GLUCONATE BAJAJ Labeling Approval
05/08/2013 QVAR 40
NDA #020911		 SUPPL-23 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
05/08/2013 QVAR 80
NDA #020911		 SUPPL-23 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
05/08/2013 LOPROX
NDA #021159		 SUPPL-20 CICLOPIROX BAUSCH Labeling Approval
05/08/2013 FLECTOR
NDA #021234		 SUPPL-10 DICLOFENAC EPOLAMINE IBSA Manufacturing (CMC) Approval
05/08/2013 LO LOESTRIN FE
NDA #022501		 SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
05/08/2013 GRIS-PEG
NDA #050475		 SUPPL-56 GRISEOFULVIN, ULTRAMICROSIZE BAUSCH Manufacturing (CMC) Approval
05/08/2013 INCIVEK
NDA #201917		 SUPPL-9 TELAPREVIR VERTEX PHARMS Manufacturing (CMC) Approval
05/08/2013 TRIAMCINOLONE ACETONIDE
ANDA #202374		 ORIG-1 TRIAMCINOLONE ACETONIDE EPIC PHARMA LLC Approval
05/08/2013 ERIVEDGE
NDA #203388		 SUPPL-1 VISMODEGIB GENENTECH Manufacturing (CMC) Approval
05/08/2013 MINASTRIN 24 FE
NDA #203667		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Type 5 - New Formulation or New Manufacturer Approval
05/09/2013 PHENERGAN VC W/ CODEINE
NDA #008306		 SUPPL-31 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE ANI PHARMS Labeling Approval
05/09/2013 PHENERGAN W/ CODEINE
NDA #008306		 SUPPL-31 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE ANI PHARMS Labeling Approval
05/09/2013 SYNALGOS-DC
NDA #011483		 SUPPL-27 ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE SUN PHARM INDUSTRIES Labeling Approval
05/09/2013 SOMA COMPOUND W/ CODEINE
NDA #012366		 SUPPL-34 ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE MEDA PHARMS Labeling Approval
05/09/2013 INDOCIN
NDA #018332		 SUPPL-35 INDOMETHACIN COSETTE Manufacturing (CMC) Approval
05/09/2013 FIORINAL W/CODEINE
NDA #019429		 SUPPL-35 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Labeling Approval
05/09/2013 FIORICET W/ CODEINE
NDA #020232		 SUPPL-35 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ACTAVIS LABS UT INC Labeling Approval
05/09/2013 DAYTRANA
NDA #021514		 SUPPL-16 METHYLPHENIDATE NOVEN PHARMS INC Manufacturing (CMC) Approval
05/09/2013 VEREGEN
NDA #021902		 SUPPL-28 SINECATECHINS ANI PHARMS Manufacturing (CMC) Approval
05/09/2013 CODEINE SULFATE
NDA #022402		 SUPPL-6 CODEINE SULFATE HIKMA Labeling Approval
05/09/2013 RITUXAN
BLA #103705		 SUPPL-5409 RITUXIMAB GENENTECH Approval
05/09/2013 ILARIS
BLA #125319		 SUPPL-62 CANAKINUMAB NOVARTIS PHARMS Approval
05/09/2013 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 ORIG-1 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Approval
05/09/2013 CODEINE SULFATE
NDA #202245		 SUPPL-2 CODEINE SULFATE HIKMA Labeling Approval
05/09/2013 LEVETIRACETAM
ANDA #203067		 ORIG-1 LEVETIRACETAM ALEMBIC Approval
05/10/2013 CONRAY
NDA #013295		 SUPPL-61 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/10/2013 CONRAY 43
NDA #013295		 SUPPL-61 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/10/2013 CONRAY 30
NDA #016983		 SUPPL-30 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/10/2013 CYSTO-CONRAY
NDA #017057		 SUPPL-28 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/10/2013 CYSTO-CONRAY II
NDA #017057		 SUPPL-28 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/10/2013 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-38 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
05/10/2013 HUMULIN R
BLA #018780		 SUPPL-142 INSULIN HUMAN LILLY Approval
05/10/2013 HUMULIN R
BLA #018780		 SUPPL-142 INSULIN RECOMBINANT HUMAN LILLY Approval
05/10/2013 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-142 INSULIN HUMAN LILLY Approval
05/10/2013 HUMULIN R PEN
BLA #018780		 SUPPL-142 INSULIN RECOMBINANT HUMAN LILLY Approval
05/10/2013 HUMULIN N
BLA #018781		 SUPPL-129 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/10/2013 CYKLOKAPRON
NDA #019281		 SUPPL-31 TRANEXAMIC ACID PFIZER Labeling Approval
05/10/2013 MD-76R
NDA #019292		 SUPPL-9 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/10/2013 HUMULIN 70/30
BLA #019717		 SUPPL-108 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/10/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-108 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/10/2013 HUMALOG
BLA #020563		 SUPPL-134 INSULIN LISPRO RECOMBINANT LILLY Approval
05/10/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-134 INSULIN LISPRO RECOMBINANT LILLY Approval
05/10/2013 HUMALOG PEN
BLA #020563		 SUPPL-134 INSULIN LISPRO RECOMBINANT LILLY Approval
05/10/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-134 INSULIN LISPRO RECOMBINANT LILLY Approval
05/10/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-88 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
05/10/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-88 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
05/10/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-88 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
05/10/2013 BESIVANCE
NDA #022308		 SUPPL-6 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
05/10/2013 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #040151		 SUPPL-13 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE HIKMA Labeling Approval
05/10/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040419		 SUPPL-14 ACETAMINOPHEN; CODEINE PHOSPHATE SPECGX LLC Labeling Approval
05/10/2013 PROMETHAZINE WITH CODEINE
ANDA #040650		 SUPPL-13 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
05/10/2013 PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
ANDA #040660		 SUPPL-12 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE PAI HOLDINGS Labeling Approval
05/10/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040779		 SUPPL-11 ACETAMINOPHEN; CODEINE PHOSPHATE AMNEAL PHARMS NY Labeling Approval
05/10/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040838		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE PHARM ASSOC Approval
05/10/2013 MEFOXIN
NDA #050517		 SUPPL-51 CEFOXITIN SODIUM PHARMOBEDIENT Labeling Approval
05/10/2013 CARVEDILOL
ANDA #077346		 SUPPL-11 CARVEDILOL SUN PHARM INDS INC Labeling Approval
05/10/2013 CARVEDILOL
ANDA #077346		 SUPPL-15 CARVEDILOL SUN PHARM INDS INC Labeling Approval
05/10/2013 LEVALBUTEROL HYDROCHLORIDE
ANDA #078309		 SUPPL-9 LEVALBUTEROL HYDROCHLORIDE MYLAN SPECIALITY LP Labeling Approval
05/10/2013 HYDROCHLOROTHIAZIDE
ANDA #078389		 SUPPL-2 HYDROCHLOROTHIAZIDE APOTEX Labeling Approval
05/10/2013 TYLENOL W/ CODEINE NO. 1
ANDA #085055		 SUPPL-53 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
05/10/2013 TYLENOL W/ CODEINE NO. 2
ANDA #085055		 SUPPL-53 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
05/10/2013 TYLENOL W/ CODEINE NO. 3
ANDA #085055		 SUPPL-53 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
05/10/2013 TYLENOL W/ CODEINE NO. 4
ANDA #085055		 SUPPL-53 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
05/10/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087508		 SUPPL-33 ACETAMINOPHEN; CODEINE PHOSPHATE GENUS LIFESCIENCES Labeling Approval
05/10/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629		 SUPPL-60 ACETAMINOPHEN; CODEINE PHOSPHATE ANI PHARMS Labeling Approval
05/10/2013 PROMETH VC W/ CODEINE
ANDA #088764		 SUPPL-84 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/10/2013 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #088875		 SUPPL-35 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
05/10/2013 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #089647		 SUPPL-10 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
05/10/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089805		 SUPPL-19 ACETAMINOPHEN; CODEINE PHOSPHATE STRIDES PHARMA INTL Labeling Approval
05/10/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089828		 SUPPL-17 ACETAMINOPHEN; CODEINE PHOSPHATE STRIDES PHARMA INTL Labeling Approval
05/10/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089990		 SUPPL-14 ACETAMINOPHEN; CODEINE PHOSPHATE STRIDES PHARMA INTL Labeling Approval
05/10/2013 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #090180		 SUPPL-5 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/10/2013 PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
ANDA #090180		 SUPPL-5 PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE CHARTWELL RX Labeling Approval
05/10/2013 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #200386		 SUPPL-2 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE COSETTE PHARMS NC Labeling Approval
05/10/2013 MONTELUKAST SODIUM
ANDA #202096		 SUPPL-6 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
05/10/2013 COMPLERA
NDA #202123		 SUPPL-9 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
05/10/2013 NYMALIZE
NDA #203340		 ORIG-1 NIMODIPINE AZURITY Type 3 - New Dosage Form Approval
05/10/2013 BREO ELLIPTA
NDA #204275		 ORIG-1 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Type 1 - New Molecular Entity Approval
05/11/2013 TASMAR
NDA #020697		 SUPPL-4 TOLCAPONE BAUSCH Labeling Approval
05/13/2013 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-37 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
05/13/2013 TRIHEXYPHENIDYL HYDROCHLORIDE
ANDA #040251		 SUPPL-5 TRIHEXYPHENIDYL HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/13/2013 VINCRISTINE SULFATE PFS
ANDA #075493		 SUPPL-30 VINCRISTINE SULFATE TEVA PHARMS USA Labeling Approval
05/13/2013 ACARBOSE
ANDA #077532		 SUPPL-6 ACARBOSE WATSON LABS Labeling Approval
05/13/2013 MINOCYCLINE HYDROCHLORIDE
ANDA #090867		 ORIG-1 MINOCYCLINE HYDROCHLORIDE SUN PHARM INDS INC Approval
05/13/2013 HUMIRA
BLA #125057		 SUPPL-310 ADALIMUMAB ABBVIE INC Approval
05/13/2013 OPANA ER
NDA #201655		 SUPPL-6 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Manufacturing (CMC) Approval
05/13/2013 ACARBOSE
ANDA #202271		 SUPPL-1 ACARBOSE AVET LIFESCIENCES Labeling Approval
05/13/2013 ENTACAPONE
ANDA #202394		 ORIG-1 ENTACAPONE PHARMOBEDIENT Approval
05/13/2013 PREPOPIK
NDA #202535		 SUPPL-1 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FERRING PHARMS INC Manufacturing (CMC) Approval
05/14/2013 RETIN-A
NDA #017579		 SUPPL-32 TRETINOIN VALEANT INTL Manufacturing (CMC) Approval
05/14/2013 RIDAURA
NDA #018689		 SUPPL-18 AURANOFIN LEGACY Manufacturing (CMC) Approval
05/14/2013 LUPRON DEPOT-PED KIT
NDA #020263		 SUPPL-39 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
05/14/2013 CLIMARA
NDA #020375		 SUPPL-30 ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
05/14/2013 MENOSTAR
NDA #020375		 SUPPL-30 ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
05/14/2013 TARCEVA
NDA #021743		 SUPPL-18 ERLOTINIB HYDROCHLORIDE OSI PHARMS Efficacy Approval
05/14/2013 MEGACE ES
NDA #021778		 SUPPL-16 MEGESTROL ACETATE ENDO OPERATIONS Labeling Approval
05/14/2013 MERCAPTOPURINE
ANDA #040594		 SUPPL-6 MERCAPTOPURINE MYLAN Labeling Approval
05/14/2013 VALACYCLOVIR HYDROCHLORIDE
ANDA #076588		 SUPPL-19 VALACYCLOVIR HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
05/14/2013 CARVEDILOL
ANDA #078332		 SUPPL-4 CARVEDILOL AUROBINDO PHARMA Labeling Approval
05/14/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085868		 SUPPL-57 ACETAMINOPHEN; CODEINE PHOSPHATE SUN PHARM INDS LTD Labeling Approval
05/14/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087083		 SUPPL-44 ACETAMINOPHEN; CODEINE PHOSPHATE SUN PHARM INDS LTD Labeling Approval
05/14/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089450		 SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL Labeling Approval
05/14/2013 ZOLMITRIPTAN
ANDA #201779		 ORIG-1 ZOLMITRIPTAN GLENMARK PHARMS LTD Approval
05/14/2013 ZOLMITRIPTAN
ANDA #202078		 ORIG-1 ZOLMITRIPTAN APOTEX INC Approval
05/14/2013 ZOLMITRIPTAN
ANDA #202476		 ORIG-1 ZOLMITRIPTAN APOTEX INC Approval
05/14/2013 ZOLMITRIPTAN
ANDA #202560		 ORIG-1 ZOLMITRIPTAN GLENMARK PHARMS LTD Approval
05/14/2013 ZOLMITRIPTAN
ANDA #203186		 ORIG-1 ZOLMITRIPTAN NATCO PHARMA USA Approval
05/15/2013 TRANSDERM SCOP
NDA #017874		 SUPPL-40 SCOPOLAMINE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
05/15/2013 PRILOSEC
NDA #019810		 SUPPL-97 OMEPRAZOLE ASTRAZENECA Labeling Approval
05/15/2013 ACCOLATE
NDA #020547		 SUPPL-32 ZAFIRLUKAST STRIDES PHARMA INTL Manufacturing (CMC) Approval
05/15/2013 PULMICORT RESPULES
NDA #020929		 SUPPL-49 BUDESONIDE ASTRAZENECA Manufacturing (CMC) Approval
05/15/2013 ROCALTROL
NDA #021068		 SUPPL-8 CALCITRIOL ESJAY PHARMA Manufacturing (CMC) Approval
05/15/2013 NORDITROPIN
BLA #021148		 SUPPL-40 SOMATROPIN NOVO NORDISK INC Approval
05/15/2013 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-40 SOMATROPIN NOVO NORDISK INC Approval
05/15/2013 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-40 SOMATROPIN NOVO NORDISK INC Approval
05/15/2013 ALTOPREV
NDA #021316		 SUPPL-30 LOVASTATIN AZURITY Manufacturing (CMC) Approval
05/15/2013 PRILOSEC
NDA #022056		 SUPPL-13 OMEPRAZOLE MAGNESIUM AZURITY Labeling Approval
05/15/2013 DUREZOL
NDA #022212		 SUPPL-12 DIFLUPREDNATE SANDOZ Labeling Approval
05/15/2013 COLCRYS
NDA #022352		 SUPPL-19 COLCHICINE TAKEDA PHARMS USA Manufacturing (CMC) Approval
05/15/2013 PEGINTRON
BLA #103949		 SUPPL-5263 PEGINTERFERON ALFA-2B SCHERING Approval
05/15/2013 SYLATRON
BLA #103949		 SUPPL-5263 PEGINTERFERON ALFA-2B SCHERING Approval
05/15/2013 SIMPONI
BLA #125289		 SUPPL-77 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
05/15/2013 SIMPONI
BLA #125289		 SUPPL-78 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
05/15/2013 SIMPONI
BLA #125289		 SUPPL-79 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
05/15/2013 KOMBIGLYZE XR
NDA #200678		 SUPPL-2 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Manufacturing (CMC) Approval
05/15/2013 QUILLIVANT XR
NDA #202100		 SUPPL-1 METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE Manufacturing (CMC) Approval
05/15/2013 ZOLMITRIPTAN
ANDA #202890		 ORIG-1 ZOLMITRIPTAN ZYDUS PHARMS USA INC Approval
05/15/2013 XOFIGO
NDA #203971		 ORIG-1 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Type 1 - New Molecular Entity Approval
05/16/2013 LANOXIN
NDA #009330		 SUPPL-27 DIGOXIN AZURITY Labeling Approval
05/16/2013 LANOXIN PEDIATRIC
NDA #009330		 SUPPL-27 DIGOXIN AZURITY Labeling Approval
05/16/2013 HABITROL
NDA #020076		 SUPPL-35 NICOTINE DR REDDYS LABS SA Manufacturing (CMC) Approval
05/16/2013 LANTUS
BLA #021081		 SUPPL-55 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
05/16/2013 LANTUS SOLOSTAR
BLA #021081		 SUPPL-55 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
05/16/2013 INSPRA
NDA #021437		 SUPPL-11 EPLERENONE UPJOHN Labeling Approval
05/16/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040119		 SUPPL-5 ACETAMINOPHEN; CODEINE PHOSPHATE PAI HOLDINGS Labeling Approval
05/16/2013 RIVASTIGMINE TARTRATE
ANDA #091072		 ORIG-1 RIVASTIGMINE TARTRATE APOTEX INC Approval
05/16/2013 PEGASYS
BLA #103964		 SUPPL-5241 PEGINTERFERON ALFA-2A Pharmaand GmbH Approval
05/16/2013 TRAMADOL HYDROCHLORIDE
ANDA #202390		 ORIG-1 TRAMADOL HYDROCHLORIDE ACCORD HLTHCARE Approval
05/16/2013 LETROZOLE
ANDA #202716		 ORIG-1 LETROZOLE CHARTWELL RX Approval
05/17/2013 ULTRAVATE
NDA #019968		 SUPPL-12 HALOBETASOL PROPIONATE SUN PHARM INDS INC Manufacturing (CMC) Approval
05/17/2013 ANGIOMAX
NDA #020873		 SUPPL-29 BIVALIRUDIN SANDOZ Labeling Approval
05/17/2013 TASIGNA
NDA #022068		 SUPPL-13 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
05/17/2013 PANTOPRAZOLE SODIUM
ANDA #077619		 SUPPL-6 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
05/17/2013 PANTOPRAZOLE SODIUM
ANDA #077619		 SUPPL-7 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
05/17/2013 ACYCLOVIR
ANDA #202459		 SUPPL-1 ACYCLOVIR PHARMOBEDIENT Manufacturing (CMC) Approval
05/17/2013 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #202529		 ORIG-1 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE RANBAXY LABS LTD Type 5 - New Formulation or New Manufacturer Tentative Approval
05/20/2013 ESTRADIOL
NDA #020538		 SUPPL-28 ESTRADIOL SANDOZ Labeling Approval
05/20/2013 ESTRADIOL
NDA #020538		 SUPPL-29 ESTRADIOL SANDOZ Labeling Approval
05/20/2013 ESTRADIOL
NDA #020538		 SUPPL-30 ESTRADIOL SANDOZ Labeling Approval
05/20/2013 VIVELLE-DOT
NDA #020538		 SUPPL-28 ESTRADIOL SANDOZ Labeling Approval
05/20/2013 VIVELLE-DOT
NDA #020538		 SUPPL-29 ESTRADIOL SANDOZ Labeling Approval
05/20/2013 VIVELLE-DOT
NDA #020538		 SUPPL-30 ESTRADIOL SANDOZ Labeling Approval
05/20/2013 ELDEPRYL
NDA #020647		 SUPPL-8 SELEGILINE HYDROCHLORIDE QUAGEN Manufacturing (CMC) Approval
05/20/2013 ANDROGEL
NDA #021015		 SUPPL-36 TESTOSTERONE BESINS HLTHCARE Labeling Approval
05/20/2013 STRATTERA
NDA #021411		 SUPPL-41 ATOMOXETINE HYDROCHLORIDE LILLY Manufacturing (CMC) Approval
05/20/2013 ANDROGEL
NDA #022309		 SUPPL-8 TESTOSTERONE BESINS HLTHCARE Labeling Approval
05/20/2013 ARGATROBAN IN SODIUM CHLORIDE
NDA #022434		 SUPPL-3 ARGATROBAN CIPLA Manufacturing (CMC) Approval
05/20/2013 CLOZAPINE
ANDA #075417		 SUPPL-31 CLOZAPINE MYLAN Labeling Approval
05/20/2013 IPRATROPIUM BROMIDE
ANDA #075693		 SUPPL-21 IPRATROPIUM BROMIDE RITEDOSE CORP Labeling Approval
05/20/2013 ESCITALOPRAM OXALATE
ANDA #077512		 SUPPL-1 ESCITALOPRAM OXALATE AIPING PHARM INC Labeling Approval
05/20/2013 TOPIRAMATE
ANDA #077733		 SUPPL-3 TOPIRAMATE PHARMACO REMS Approval
05/20/2013 ESCITALOPRAM OXALATE
ANDA #079121		 SUPPL-1 ESCITALOPRAM OXALATE SUN PHARMA CANADA Labeling Approval
05/20/2013 ESCITALOPRAM OXALATE
ANDA #079121		 SUPPL-2 ESCITALOPRAM OXALATE SUN PHARMA CANADA Labeling Approval
05/20/2013 HEPARIN SODIUM
ANDA #088100		 SUPPL-41 HEPARIN SODIUM HOSPIRA Labeling Approval
05/21/2013 METHERGINE
NDA #006035		 SUPPL-79 METHYLERGONOVINE MALEATE EDISON THERAPS LLC Manufacturing (CMC) Approval
05/21/2013 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019615		 SUPPL-22 DOPAMINE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/21/2013 LANOXIN
NDA #020405		 SUPPL-9 DIGOXIN ADVANZ PHARMA Manufacturing (CMC) Approval
05/21/2013 OPTIMARK
NDA #020937		 SUPPL-21 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
05/21/2013 OPTIMARK
NDA #020975		 SUPPL-22 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
05/21/2013 OPTIMARK IN PLASTIC CONTAINER
NDA #020976		 SUPPL-22 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
05/21/2013 RAZADYNE
NDA #021169		 SUPPL-28 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Manufacturing (CMC) Approval
05/21/2013 RAZADYNE
NDA #021224		 SUPPL-26 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Manufacturing (CMC) Approval
05/21/2013 RAZADYNE ER
NDA #021615		 SUPPL-19 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Manufacturing (CMC) Approval
05/21/2013 CUVPOSA
NDA #022571		 SUPPL-3 GLYCOPYRROLATE MERZ PHARMS Labeling Approval
05/21/2013 ERYTHROMYCIN
ANDA #062447		 SUPPL-29 ERYTHROMYCIN PADAGIS US Manufacturing (CMC) Approval
05/21/2013 AMIODARONE HYDROCHLORIDE
ANDA #077161		 SUPPL-7 AMIODARONE HYDROCHLORIDE GLAND PHARMA LTD Manufacturing (CMC) Approval
05/21/2013 SUMATRIPTAN SUCCINATE
ANDA #078298		 ORIG-1 SUMATRIPTAN SUCCINATE HIKMA PHARMS Approval
05/21/2013 CICLOPIROX
ANDA #078463		 SUPPL-1 CICLOPIROX COSETTE PHARMS NC Manufacturing (CMC) Approval
05/21/2013 STELARA
BLA #125261		 SUPPL-86 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
05/21/2013 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-2 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
05/21/2013 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-4 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-38 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/22/2013 CIPRODEX
NDA #021537		 SUPPL-8 CIPROFLOXACIN; DEXAMETHASONE SANDOZ Manufacturing (CMC) Approval
05/22/2013 TASIGNA
NDA #022068		 SUPPL-16 NILOTINIB HYDROCHLORIDE NOVARTIS REMS Approval
05/22/2013 YERVOY
BLA #125377		 SUPPL-44 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
05/23/2013 CONDYLOX
NDA #019795		 SUPPL-13 PODOFILOX TEVA BRANDED PHARM Manufacturing (CMC) Approval
05/23/2013 TYGACIL
NDA #021821		 SUPPL-37 TIGECYCLINE PF PRISM CV Labeling Approval
05/23/2013 NICORETTE
NDA #022360		 SUPPL-6 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
05/23/2013 CLOMIPHENE CITRATE
ANDA #075528		 SUPPL-9 CLOMIPHENE CITRATE COSETTE Labeling Approval
05/23/2013 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #079198		 SUPPL-3 OCTREOTIDE ACETATE MYLAN INSTITUTIONAL Labeling Approval
05/23/2013 HEPARIN SODIUM
ANDA #090571		 SUPPL-7 HEPARIN SODIUM HOSPIRA INC Labeling Approval
05/23/2013 IMIPENEM AND CILASTATIN
ANDA #090825		 SUPPL-1 CILASTATIN SODIUM; IMIPENEM HOSPIRA INC Labeling Approval
05/24/2013 HALDOL
NDA #018701		 SUPPL-67 HALOPERIDOL DECANOATE JANSSEN PHARMS Manufacturing (CMC) Approval
05/24/2013 HUMATROPE
BLA #019640		 SUPPL-90 SOMATROPIN LILLY Approval
05/24/2013 STIMATE
NDA #020355		 SUPPL-17 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
05/24/2013 STIMATE (NEEDS NO REFRIGERATION)
NDA #020355		 SUPPL-17 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
05/24/2013 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-36 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Manufacturing (CMC) Approval
05/24/2013 PLAVIX
NDA #020839		 SUPPL-56 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Manufacturing (CMC) Approval
05/24/2013 LUVOX
NDA #021519		 SUPPL-4 FLUVOXAMINE MALEATE ANI PHARMS Manufacturing (CMC) Approval
05/24/2013 ONGLYZA
NDA #022350		 SUPPL-11 SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Efficacy Approval
05/24/2013 PANTOPRAZOLE SODIUM
ANDA #078281		 SUPPL-12 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
05/24/2013 PANTOPRAZOLE SODIUM
ANDA #078281		 SUPPL-13 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
05/24/2013 PANTOPRAZOLE SODIUM
ANDA #079197		 SUPPL-1 PANTOPRAZOLE SODIUM EPIC PHARMA LLC Labeling Approval
05/24/2013 CALCITRIOL
ANDA #091174		 ORIG-1 CALCITRIOL BIONPHARMA Approval
05/24/2013 TYSABRI
BLA #125104		 SUPPL-813 NATALIZUMAB BIOGEN IDEC Approval
05/24/2013 KOMBIGLYZE XR
NDA #200678		 SUPPL-10 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Efficacy Approval
05/24/2013 TROSPIUM CHLORIDE
ANDA #201291		 ORIG-1 TROSPIUM CHLORIDE PADAGIS US Approval
05/28/2013 SUCRAID
BLA #020772		 SUPPL-13 SACROSIDASE QOL MEDCL Approval
05/28/2013 VIRACEPT
NDA #020778		 SUPPL-38 NELFINAVIR MESYLATE AGOURON PHARMS Labeling Approval
05/28/2013 VIRACEPT
NDA #020779		 SUPPL-59 NELFINAVIR MESYLATE AGOURON PHARMS Labeling Approval
05/28/2013 VIRACEPT
NDA #021503		 SUPPL-21 NELFINAVIR MESYLATE AGOURON PHARMS Labeling Approval
05/28/2013 LUVOX
NDA #021519		 SUPPL-5 FLUVOXAMINE MALEATE ANI PHARMS Manufacturing (CMC) Approval
05/28/2013 GILENYA
NDA #022527		 SUPPL-10 FINGOLIMOD HYDROCHLORIDE NOVARTIS REMS Approval
05/28/2013 ESCITALOPRAM OXALATE
ANDA #076765		 SUPPL-1 ESCITALOPRAM OXALATE TEVA PHARMS USA Labeling Approval
05/28/2013 LOSARTAN POTASSIUM
ANDA #077424		 SUPPL-5 LOSARTAN POTASSIUM CHARTWELL RX Labeling Approval
05/28/2013 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #090182		 SUPPL-14 CETIRIZINE HYDROCHLORIDE TARO Labeling Approval
05/28/2013 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #090182		 SUPPL-14 CETIRIZINE HYDROCHLORIDE TARO Labeling Approval
05/28/2013 CLOPIDOGREL BISULFATE
ANDA #090307		 ORIG-1 CLOPIDOGREL BISULFATE ACTAVIS TOTOWA Approval
05/28/2013 LOSARTAN POTASSIUM
ANDA #090382		 SUPPL-9 LOSARTAN POTASSIUM STRIDES PHARMA Labeling Approval
05/28/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-11 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
05/28/2013 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #091633		 ORIG-1 HYDROCODONE BITARTRATE; IBUPROFEN SUN PHARM INDS INC Approval
05/28/2013 VORICONAZOLE
ANDA #202361		 ORIG-1 VORICONAZOLE RISING Approval
05/28/2013 METOPROLOL TARTRATE
ANDA #202871		 ORIG-1 METOPROLOL TARTRATE ALEMBIC PHARMS LTD Approval
05/28/2013 ISENTRESS
NDA #203045		 SUPPL-6 RALTEGRAVIR POTASSIUM MSD SUB MERCK Manufacturing (CMC) Approval
05/29/2013 PROSTIN E2
NDA #017810		 SUPPL-18 DINOPROSTONE PFIZER Manufacturing (CMC) Approval
05/29/2013 BSS PLUS
NDA #018469		 SUPPL-52 CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE ALCON Manufacturing (CMC) Approval
05/29/2013 TECHNESCAN HIDA
NDA #018489		 SUPPL-52 TECHNETIUM TC-99M LIDOFENIN KIT DRAXIMAGE Manufacturing (CMC) Approval
05/29/2013 MAGNESIUM SULFATE
NDA #019316		 SUPPL-18 MAGNESIUM SULFATE FRESENIUS KABI USA Labeling Approval
05/29/2013 PRAVACHOL
NDA #019898		 SUPPL-65 PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
05/29/2013 MAGNESIUM SULFATE IN PLASTIC CONTAINER
NDA #020309		 SUPPL-28 MAGNESIUM SULFATE HOSPIRA Labeling Approval
05/29/2013 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020488		 SUPPL-19 MAGNESIUM SULFATE HOSPIRA Labeling Approval
05/29/2013 AGGRENOX
NDA #020884		 SUPPL-32 ASPIRIN; DIPYRIDAMOLE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
05/29/2013 LEXAPRO
NDA #021323		 SUPPL-43 ESCITALOPRAM OXALATE ABBVIE Manufacturing (CMC) Approval
05/29/2013 OXYTROL
NDA #021351		 SUPPL-10 OXYBUTYNIN ALLERGAN Manufacturing (CMC) Approval
05/29/2013 EXJADE
NDA #021882		 SUPPL-17 DEFERASIROX NOVARTIS Labeling Approval
05/29/2013 AXIRON
NDA #022504		 SUPPL-8 TESTOSTERONE ELI LILLY AND CO Manufacturing (CMC) Approval
05/29/2013 TIMENTIN IN PLASTIC CONTAINER
NDA #050658		 SUPPL-28 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Manufacturing (CMC) Approval
05/29/2013 KETOROLAC TROMETHAMINE
ANDA #074802		 SUPPL-37 KETOROLAC TROMETHAMINE HOSPIRA Labeling Approval
05/29/2013 KETOROLAC TROMETHAMINE
ANDA #074993		 SUPPL-17 KETOROLAC TROMETHAMINE HOSPIRA Labeling Approval
05/29/2013 MINOXIDIL EXTRA STRENGTH (FOR MEN)
ANDA #075518		 SUPPL-24 MINOXIDIL P AND L Labeling Approval
05/29/2013 TEFLARO
NDA #200327		 SUPPL-9 CEFTAROLINE FOSAMIL ABBVIE Labeling Approval
05/29/2013 OPANA ER
NDA #201655		 SUPPL-7 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Manufacturing (CMC) Approval
05/29/2013 TAFINLAR
NDA #202806		 ORIG-1 DABRAFENIB MESYLATE NOVARTIS Type 1 - New Molecular Entity Approval
05/29/2013 STIVARGA
NDA #203085		 SUPPL-1 REGORAFENIB BAYER HLTHCARE Labeling Approval
05/29/2013 DEXTROAMPHETAMINE SULFATE
ANDA #203644		 ORIG-1 DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Approval
05/29/2013 MEKINIST
NDA #204114		 ORIG-1 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Type 1 - New Molecular Entity Approval
05/30/2013 CONRAY
NDA #013295		 SUPPL-62 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/30/2013 CONRAY 43
NDA #013295		 SUPPL-62 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/30/2013 CYSTO-CONRAY
NDA #017057		 SUPPL-29 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/30/2013 CYSTO-CONRAY II
NDA #017057		 SUPPL-29 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
05/30/2013 HUMULIN R
BLA #018780		 SUPPL-143 INSULIN HUMAN LILLY Approval
05/30/2013 HUMULIN R
BLA #018780		 SUPPL-143 INSULIN RECOMBINANT HUMAN LILLY Approval
05/30/2013 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-143 INSULIN HUMAN LILLY Approval
05/30/2013 HUMULIN R PEN
BLA #018780		 SUPPL-143 INSULIN RECOMBINANT HUMAN LILLY Approval
05/30/2013 HUMULIN N
BLA #018781		 SUPPL-133 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-37 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/30/2013 HUMULIN 70/30
BLA #019717		 SUPPL-112 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/30/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-112 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/30/2013 RAPAMUNE
NDA #021083		 SUPPL-54 SIROLIMUS PF PRISM CV Labeling Approval
05/30/2013 RAPAMUNE
NDA #021110		 SUPPL-68 SIROLIMUS PF PRISM CV Labeling Approval
05/30/2013 UROXATRAL
NDA #021287		 SUPPL-17 ALFUZOSIN HYDROCHLORIDE ADVANZ PHARMA Labeling Approval
05/30/2013 FANAPT
NDA #022192		 SUPPL-11 ILOPERIDONE VANDA PHARMS INC Manufacturing (CMC) Approval
05/30/2013 NESINA
NDA #022271		 SUPPL-1 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
05/30/2013 GRANISETRON HYDROCHLORIDE
ANDA #077297		 SUPPL-12 GRANISETRON HYDROCHLORIDE DR REDDYS Labeling Approval
05/30/2013 GRANISETRON HYDROCHLORIDE
ANDA #077297		 SUPPL-13 GRANISETRON HYDROCHLORIDE DR REDDYS Labeling Approval
05/30/2013 GRANISETRON HYDROCHLORIDE
ANDA #077963		 SUPPL-12 GRANISETRON HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
05/30/2013 GRANISETRON HYDROCHLORIDE
ANDA #077963		 SUPPL-13 GRANISETRON HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
05/30/2013 GRANISETRON HYDROCHLORIDE
ANDA #078392		 SUPPL-13 GRANISETRON HYDROCHLORIDE DR REDDYS Labeling Approval
05/30/2013 GRANISETRON HYDROCHLORIDE
ANDA #078392		 SUPPL-14 GRANISETRON HYDROCHLORIDE DR REDDYS Labeling Approval
05/30/2013 PANTOPRAZOLE SODIUM
ANDA #090074		 SUPPL-6 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
05/30/2013 PANTOPRAZOLE SODIUM
ANDA #090074		 SUPPL-8 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
05/30/2013 PANTOPRAZOLE SODIUM
ANDA #090797		 SUPPL-6 PANTOPRAZOLE SODIUM ACTAVIS TOTOWA Labeling Approval
05/30/2013 PANTOPRAZOLE SODIUM
ANDA #090797		 SUPPL-7 PANTOPRAZOLE SODIUM ACTAVIS TOTOWA Labeling Approval
05/30/2013 PANTOPRAZOLE SODIUM
ANDA #090807		 SUPPL-1 PANTOPRAZOLE SODIUM RUBICON RESEARCH Labeling Approval
05/30/2013 PANTOPRAZOLE SODIUM
ANDA #090901		 SUPPL-5 PANTOPRAZOLE SODIUM JUBILANT GENERICS Labeling Approval
05/30/2013 FAMCICLOVIR
ANDA #091114		 SUPPL-2 FAMCICLOVIR AUROBINDO PHARMA LTD Labeling Approval
05/30/2013 KEPIVANCE
BLA #125103		 SUPPL-146 PALIFERMIN BIOVITRUM AB Approval
05/30/2013 NPLATE
BLA #125268		 SUPPL-121 ROMIPLOSTIM AMGEN Approval
05/30/2013 FAMCICLOVIR
ANDA #201022		 SUPPL-1 FAMCICLOVIR MACLEODS PHARMS LTD Labeling Approval
05/30/2013 FAMCICLOVIR
ANDA #201022		 SUPPL-2 FAMCICLOVIR MACLEODS PHARMS LTD Labeling Approval
05/30/2013 NEVIRAPINE
ANDA #203176		 SUPPL-1 NEVIRAPINE TECH ORGANIZED Labeling Approval
05/31/2013 HUMULIN R
BLA #018780		 SUPPL-144 INSULIN HUMAN LILLY Approval
05/31/2013 HUMULIN R
BLA #018780		 SUPPL-144 INSULIN RECOMBINANT HUMAN LILLY Approval
05/31/2013 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-144 INSULIN HUMAN LILLY Approval
05/31/2013 HUMULIN R PEN
BLA #018780		 SUPPL-144 INSULIN RECOMBINANT HUMAN LILLY Approval
05/31/2013 HUMULIN N
BLA #018781		 SUPPL-134 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/31/2013 HUMULIN 70/30
BLA #019717		 SUPPL-113 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/31/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-113 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
05/31/2013 REBETOL
NDA #020903		 SUPPL-51 RIBAVIRIN MERCK SHARP DOHME Labeling Approval
05/31/2013 REBETOL
NDA #021546		 SUPPL-7 RIBAVIRIN SCHERING Labeling Approval
05/31/2013 VEREGEN
NDA #021902		 SUPPL-27 SINECATECHINS ANI PHARMS Manufacturing (CMC) Approval
05/31/2013 VIBATIV
NDA #022110		 SUPPL-6 TELAVANCIN HYDROCHLORIDE CUMBERLAND Manufacturing (CMC) Approval
05/31/2013 RESTASIS
NDA #050790		 SUPPL-21 CYCLOSPORINE ABBVIE Manufacturing (CMC) Approval
05/31/2013 RESTASIS MULTIDOSE
NDA #050790		 SUPPL-21 CYCLOSPORINE ABBVIE Manufacturing (CMC) Approval
05/31/2013 AMPICILLIN SODIUM
ANDA #062772		 SUPPL-9 AMPICILLIN SODIUM HQ SPECLT PHARMA Labeling Approval
05/31/2013 AMPICILLIN SODIUM
ANDA #063147		 SUPPL-9 AMPICILLIN SODIUM HANFORD GC Labeling Approval
05/31/2013 DOXYCYCLINE
ANDA #065070		 SUPPL-18 DOXYCYCLINE STRIDES PHARMA INTL Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #074739		 SUPPL-30 AMIODARONE HYDROCHLORIDE TEVA PHARMS Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-27 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-28 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-16 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-17 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
05/31/2013 CLONAZEPAM
ANDA #075468		 SUPPL-17 CLONAZEPAM RUBICON RESEARCH Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-10 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-11 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #077069		 SUPPL-4 AMIODARONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/31/2013 METOPROLOL SUCCINATE
ANDA #077298		 SUPPL-1 METOPROLOL SUCCINATE ACTAVIS LABS FL INC Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #077610		 SUPPL-2 AMIODARONE HYDROCHLORIDE ACELLA Labeling Approval
05/31/2013 VALACYCLOVIR HYDROCHLORIDE
ANDA #078518		 SUPPL-3 VALACYCLOVIR HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
05/31/2013 ESCITALOPRAM OXALATE
ANDA #078604		 SUPPL-1 ESCITALOPRAM OXALATE INVAGEN PHARMS Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #079029		 SUPPL-3 AMIODARONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
05/31/2013 AMIODARONE HYDROCHLORIDE
ANDA #079029		 SUPPL-5 AMIODARONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
05/31/2013 ESCITALOPRAM OXALATE
ANDA #079062		 SUPPL-1 ESCITALOPRAM OXALATE AUROBINDO PHARMA LTD Labeling Approval
05/31/2013 MINOCYCLINE HYDROCHLORIDE
ANDA #090024		 SUPPL-6 MINOCYCLINE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
05/31/2013 ESCITALOPRAM OXALATE
ANDA #090432		 SUPPL-2 ESCITALOPRAM OXALATE AUROBINDO PHARMA LTD Labeling Approval
05/31/2013 PANTOPRAZOLE SODIUM
ANDA #200794		 SUPPL-1 PANTOPRAZOLE SODIUM SUN PHARM INDS LTD Labeling Approval
05/31/2013 PANTOPRAZOLE SODIUM
ANDA #200794		 SUPPL-2 PANTOPRAZOLE SODIUM SUN PHARM INDS LTD Labeling Approval
05/31/2013 BLOXIVERZ
NDA #204078		 ORIG-1 NEOSTIGMINE METHYLSULFATE EXELA PHARMA Type 5 - New Formulation or New Manufacturer Approval
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