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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 2015

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 September 15, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/01/2015 FUROSEMIDE
NDA #018902		 SUPPL-26 FUROSEMIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
07/01/2015 PRIFTIN
NDA #021024		 SUPPL-13 RIFAPENTINE SANOFI AVENTIS US Labeling Approval
07/01/2015 VICTOZA
NDA #022341		 SUPPL-24 LIRAGLUTIDE NOVO NORDISK INC REMS Approval
07/01/2015 MYCOBUTIN
NDA #050689		 SUPPL-22 RIFABUTIN PFIZER Labeling Approval
07/01/2015 PROGRAF
NDA #050709		 SUPPL-37 TACROLIMUS ASTELLAS Manufacturing (CMC) Approval
07/01/2015 CLARITHROMYCIN
ANDA #065136		 SUPPL-16 CLARITHROMYCIN SANDOZ Labeling Approval
07/01/2015 CLARITHROMYCIN
ANDA #065136		 SUPPL-17 CLARITHROMYCIN SANDOZ Labeling Approval
07/01/2015 CLARITHROMYCIN
ANDA #065136		 SUPPL-18 CLARITHROMYCIN SANDOZ Labeling Approval
07/01/2015 CLARITHROMYCIN
ANDA #065144		 SUPPL-15 CLARITHROMYCIN SANDOZ Labeling Approval
07/01/2015 CLARITHROMYCIN
ANDA #065144		 SUPPL-16 CLARITHROMYCIN SANDOZ Labeling Approval
07/01/2015 CLARITHROMYCIN
ANDA #065144		 SUPPL-17 CLARITHROMYCIN SANDOZ Labeling Approval
07/01/2015 ATENOLOL
ANDA #073457		 SUPPL-35 ATENOLOL MYLAN Labeling Approval
07/01/2015 SOTALOL HYDROCHLORIDE
ANDA #076214		 SUPPL-4 SOTALOL HYDROCHLORIDE APOTEX Labeling Approval
07/01/2015 ZALEPLON
ANDA #077239		 SUPPL-1 ZALEPLON TEVA PHARMS Labeling Approval
07/01/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #077760		 SUPPL-8 PROPRANOLOL HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
07/01/2015 MELOXICAM
ANDA #077944		 SUPPL-12 MELOXICAM LUPIN PHARMS Labeling Approval
07/01/2015 PROLENSA
NDA #203168		 SUPPL-1 BROMFENAC SODIUM BAUSCH AND LOMB Manufacturing (CMC) Approval
07/01/2015 KYNAMRO
NDA #203568		 SUPPL-6 MIPOMERSEN SODIUM KASTLE THERAPS LLC Manufacturing (CMC) Approval
07/01/2015 AFINITOR DISPERZ
NDA #203985		 SUPPL-6 EVEROLIMUS NOVARTIS PHARM Manufacturing (CMC) Approval
07/02/2015 GILENYA
NDA #022527		 SUPPL-16 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
07/02/2015 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040746		 SUPPL-15 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Labeling Approval
07/02/2015 ZMAX
NDA #050797		 SUPPL-19 AZITHROMYCIN PF PRISM CV Labeling Approval
07/02/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075817		 SUPPL-30 CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
07/02/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075817		 SUPPL-32 CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
07/02/2015 PAMIDRONATE DISODIUM
ANDA #076207		 SUPPL-13 PAMIDRONATE DISODIUM FRESENIUS KABI USA Labeling Approval
07/02/2015 SUMATRIPTAN SUCCINATE
ANDA #076933		 SUPPL-3 SUMATRIPTAN SUCCINATE WATSON LABS Labeling Approval
07/02/2015 SUMATRIPTAN SUCCINATE
ANDA #076933		 SUPPL-8 SUMATRIPTAN SUCCINATE WATSON LABS Labeling Approval
07/02/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077173		 SUPPL-3 ONDANSETRON HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
07/02/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077173		 SUPPL-5 ONDANSETRON HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
07/02/2015 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #077858		 SUPPL-4 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE RISING Labeling Approval
07/02/2015 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #077858		 SUPPL-5 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE RISING Labeling Approval
07/02/2015 AMIODARONE HYDROCHLORIDE
ANDA #078578		 SUPPL-5 AMIODARONE HYDROCHLORIDE RUBICON Labeling Approval
07/02/2015 AMIODARONE HYDROCHLORIDE
ANDA #078578		 SUPPL-6 AMIODARONE HYDROCHLORIDE RUBICON Labeling Approval
07/02/2015 ROCURONIUM BROMIDE
ANDA #078651		 SUPPL-4 ROCURONIUM BROMIDE FRESENIUS KABI USA Labeling Approval
07/02/2015 ROCURONIUM BROMIDE
ANDA #078651		 SUPPL-5 ROCURONIUM BROMIDE FRESENIUS KABI USA Labeling Approval
07/02/2015 PAROXETINE HYDROCHLORIDE
ANDA #078902		 SUPPL-15 PAROXETINE HYDROCHLORIDE MYLAN Labeling Approval
07/02/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090362		 SUPPL-3 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM Labeling Approval
07/02/2015 ZOLEDRONIC ACID
ANDA #202163		 SUPPL-2 ZOLEDRONIC ACID CHARTWELL RX Labeling Approval
07/02/2015 ZOLEDRONIC ACID
ANDA #202163		 SUPPL-3 ZOLEDRONIC ACID CHARTWELL RX Labeling Approval
07/02/2015 ORKAMBI
NDA #206038		 ORIG-1 IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC Type 1 - New Molecular Entity Approval
07/06/2015 CHOLOGRAFIN MEGLUMINE
NDA #009321		 SUPPL-28 IODIPAMIDE MEGLUMINE BRACCO Labeling Approval
07/06/2015 CHOLOGRAFIN SODIUM
NDA #009321		 SUPPL-28 IODIPAMIDE SODIUM BRACCO Labeling Approval
07/06/2015 CYSTOGRAFIN
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
07/06/2015 CYSTOGRAFIN DILUTE
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
07/06/2015 DIATRIZOATE MEGLUMINE
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
07/06/2015 RENO-30
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
07/06/2015 RENO-60
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
07/06/2015 RENO-DIP
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
07/06/2015 RENOGRAFIN-60
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
07/06/2015 RENOGRAFIN-76
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
07/06/2015 RENOVIST
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
07/06/2015 RENOVIST II
NDA #010040		 SUPPL-171 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
07/06/2015 CONRAY
NDA #013295		 SUPPL-68 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 CONRAY 43
NDA #013295		 SUPPL-68 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 CONRAY 30
NDA #016983		 SUPPL-35 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 ISOVUE-128
NDA #018735		 SUPPL-56 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-200
NDA #018735		 SUPPL-56 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-250
NDA #018735		 SUPPL-56 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-300
NDA #018735		 SUPPL-56 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-370
NDA #018735		 SUPPL-56 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-M 200
NDA #018735		 SUPPL-56 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-M 300
NDA #018735		 SUPPL-56 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 HEXABRIX
NDA #018905		 SUPPL-24 IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM GUERBET Labeling Approval
07/06/2015 OMNIPAQUE 12
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 140
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 180
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 210
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 240
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 300
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 350
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 70
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 9
NDA #018956		 SUPPL-95 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 MD-76R
NDA #019292		 SUPPL-10 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 160
NDA #019710		 SUPPL-52 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 240
NDA #019710		 SUPPL-52 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 300
NDA #019710		 SUPPL-52 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 320
NDA #019710		 SUPPL-52 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 350
NDA #019710		 SUPPL-52 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 CAPEX
NDA #020001		 SUPPL-11 FLUOCINOLONE ACETONIDE GALDERMA LABS LP Manufacturing (CMC) Approval
07/06/2015 PROSCAR
NDA #020180		 SUPPL-45 FINASTERIDE ORGANON Manufacturing (CMC) Approval
07/06/2015 ULTRAVIST 150
NDA #020220		 SUPPL-41 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/06/2015 ULTRAVIST 240
NDA #020220		 SUPPL-41 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/06/2015 ULTRAVIST 300
NDA #020220		 SUPPL-41 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/06/2015 ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220		 SUPPL-41 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/06/2015 ULTRAVIST 370
NDA #020220		 SUPPL-41 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/06/2015 OXILAN-300
NDA #020316		 SUPPL-28 IOXILAN GUERBET Labeling Approval
07/06/2015 OXILAN-350
NDA #020316		 SUPPL-28 IOXILAN GUERBET Labeling Approval
07/06/2015 ISOVUE-200
NDA #020327		 SUPPL-10 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-250
NDA #020327		 SUPPL-10 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-300
NDA #020327		 SUPPL-10 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 ISOVUE-370
NDA #020327		 SUPPL-10 IOPAMIDOL BRACCO Labeling Approval
07/06/2015 VISIPAQUE 270
NDA #020351		 SUPPL-43 IODIXANOL GE HEALTHCARE Labeling Approval
07/06/2015 VISIPAQUE 320
NDA #020351		 SUPPL-43 IODIXANOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 240
NDA #020608		 SUPPL-31 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 300
NDA #020608		 SUPPL-31 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 OMNIPAQUE 350
NDA #020608		 SUPPL-31 IOHEXOL GE HEALTHCARE Labeling Approval
07/06/2015 VISIPAQUE 270
NDA #020808		 SUPPL-24 IODIXANOL GE HEALTHCARE Labeling Approval
07/06/2015 VISIPAQUE 320
NDA #020808		 SUPPL-24 IODIXANOL GE HEALTHCARE Labeling Approval
07/06/2015 OPTIRAY 240
NDA #020923		 SUPPL-18 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 300
NDA #020923		 SUPPL-18 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 320
NDA #020923		 SUPPL-18 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 OPTIRAY 350
NDA #020923		 SUPPL-18 IOVERSOL LIEBEL-FLARSHEIM Labeling Approval
07/06/2015 ULTRAVIST (PHARMACY BULK)
NDA #021425		 SUPPL-24 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/06/2015 TARCEVA
NDA #021743		 SUPPL-22 ERLOTINIB HYDROCHLORIDE OSI PHARMS Manufacturing (CMC) Approval
07/06/2015 VEREGEN
NDA #021902		 SUPPL-29 SINECATECHINS ANI PHARMS Manufacturing (CMC) Approval
07/06/2015 ZALEPLON
ANDA #077238		 SUPPL-5 ZALEPLON MYLAN Labeling Approval
07/06/2015 EXEMESTANE
ANDA #077431		 SUPPL-3 EXEMESTANE HIKMA Labeling Approval
07/06/2015 EXEMESTANE
ANDA #077431		 SUPPL-4 EXEMESTANE HIKMA Labeling Approval
07/06/2015 FENOFIBRIC ACID
ANDA #200750		 SUPPL-4 CHOLINE FENOFIBRATE CHARTWELL RX Labeling Approval
07/06/2015 FENOFIBRIC ACID
ANDA #200913		 SUPPL-2 CHOLINE FENOFIBRATE MYLAN PHARMS INC Labeling Approval
07/06/2015 FENOFIBRIC ACID
ANDA #201573		 SUPPL-6 CHOLINE FENOFIBRATE ENDO OPERATIONS Labeling Approval
07/07/2015 LOTENSIN HCT
NDA #020033		 SUPPL-51 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Manufacturing (CMC) Approval
07/07/2015 NORDITROPIN
BLA #021148		 SUPPL-44 SOMATROPIN NOVO NORDISK INC Approval
07/07/2015 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-44 SOMATROPIN NOVO NORDISK INC Approval
07/07/2015 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-44 SOMATROPIN NOVO NORDISK INC Approval
07/07/2015 EFFIENT
NDA #022307		 SUPPL-12 PRASUGREL HYDROCHLORIDE COSETTE Labeling Approval
07/07/2015 NIACIN
ANDA #076250		 SUPPL-11 NIACIN BARR Labeling Approval
07/07/2015 NIACIN
ANDA #076378		 SUPPL-13 NIACIN BARR Labeling Approval
07/07/2015 CITALOPRAM HYDROBROMIDE
ANDA #077601		 SUPPL-5 CITALOPRAM HYDROBROMIDE PHARM ASSOC Labeling Approval
07/07/2015 ALMOTRIPTAN MALATE
ANDA #078027		 ORIG-1 ALMOTRIPTAN MALATE TEVA PHARMS USA Approval
07/07/2015 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901		 SUPPL-11 FLUOXETINE HYDROCHLORIDE; OLANZAPINE EPIC PHARMA LLC Labeling Approval
07/07/2015 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901		 SUPPL-12 FLUOXETINE HYDROCHLORIDE; OLANZAPINE EPIC PHARMA LLC Labeling Approval
07/07/2015 LOSARTAN POTASSIUM
ANDA #090083		 SUPPL-11 LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
07/07/2015 REPAGLINIDE
ANDA #090252		 SUPPL-1 REPAGLINIDE MYLAN Labeling Approval
07/07/2015 NIACIN
ANDA #090860		 SUPPL-4 NIACIN CHARTWELL RX Labeling Approval
07/07/2015 NIACIN
ANDA #090892		 SUPPL-4 NIACIN CHARTWELL RX Labeling Approval
07/07/2015 LINEZOLID
ANDA #205442		 ORIG-1 LINEZOLID HOSPIRA Approval
07/07/2015 ENTRESTO
NDA #207620		 ORIG-1 SACUBITRIL; VALSARTAN NOVARTIS PHARMS CORP Type 1 - New Molecular Entity and Type 4 - New Combination Approval
07/08/2015 DANTRIUM
NDA #017443		 SUPPL-65 DANTROLENE SODIUM ENDO OPERATIONS Manufacturing (CMC) Approval
07/08/2015 PRINIVIL
NDA #019558		 SUPPL-57 LISINOPRIL MERCK Labeling Approval
07/08/2015 TIKOSYN
NDA #020931		 SUPPL-9 DOFETILIDE PFIZER REMS Approval
07/08/2015 FLUDEOXYGLUCOSE F18
NDA #021870		 SUPPL-10 FLUDEOXYGLUCOSE F-18 FEINSTEIN Labeling Approval
07/08/2015 TREANDA
NDA #022249		 SUPPL-18 BENDAMUSTINE HYDROCHLORIDE CEPHALON Manufacturing (CMC) Approval
07/08/2015 THIOTEPA
ANDA #075547		 SUPPL-6 THIOTEPA WEST-WARD PHARMS INT Labeling Approval
07/08/2015 FENTANYL-100
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 FENTANYL-12
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 FENTANYL-25
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 FENTANYL-37
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 FENTANYL-50
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 FENTANYL-62
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 FENTANYL-75
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 FENTANYL-87
ANDA #076258		 SUPPL-27 FENTANYL MYLAN TECHNOLOGIES Manufacturing (CMC) Approval
07/08/2015 TRIACIN-C
ANDA #088704		 SUPPL-33 CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE ANIMA Labeling Approval
07/08/2015 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #202250		 ORIG-1 NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE WATSON LABS INC Approval
07/08/2015 DICLOFENAC SODIUM
ANDA #202769		 ORIG-1 DICLOFENAC SODIUM PAI HOLDINGS PHARM Approval
07/08/2015 SIGNIFOR LAR KIT
NDA #203255		 SUPPL-1 PASIREOTIDE PAMOATE RECORDATI RARE Manufacturing (CMC) Approval
07/08/2015 KYNAMRO
NDA #203568		 SUPPL-7 MIPOMERSEN SODIUM KASTLE THERAPS LLC Manufacturing (CMC) Approval
07/08/2015 CARISOPRODOL
ANDA #205126		 ORIG-1 CARISOPRODOL WILSHIRE PHARMS INC Approval
07/09/2015 TENORMIN
NDA #018240		 SUPPL-33 ATENOLOL TWI PHARMS Manufacturing (CMC) Approval
07/09/2015 PEPCID AC
NDA #020325		 SUPPL-28 FAMOTIDINE J AND J CONSUMER INC Manufacturing (CMC) Approval
07/09/2015 ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
NDA #020786		 SUPPL-34 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
07/09/2015 COMBIVENT RESPIMAT
NDA #021747		 SUPPL-8 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
07/09/2015 ACZONE
NDA #021794		 SUPPL-13 DAPSONE ABBVIE Labeling Approval
07/09/2015 AZOR
NDA #022100		 SUPPL-27 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
07/09/2015 VIMPAT
NDA #022253		 SUPPL-30 LACOSAMIDE UCB INC Labeling Approval
07/09/2015 VIMPAT
NDA #022254		 SUPPL-22 LACOSAMIDE UCB INC Labeling Approval
07/09/2015 VIMPAT
NDA #022255		 SUPPL-16 LACOSAMIDE UCB INC Labeling Approval
07/09/2015 CONZIP
NDA #022370		 SUPPL-13 TRAMADOL HYDROCHLORIDE CIPHER PHARMS INC Manufacturing (CMC) Approval
07/09/2015 CELLCEPT
NDA #050722		 SUPPL-33 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
07/09/2015 CELLCEPT
NDA #050723		 SUPPL-32 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
07/09/2015 CELLCEPT
NDA #050758		 SUPPL-30 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Labeling Approval
07/09/2015 CELLCEPT
NDA #050759		 SUPPL-38 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
07/09/2015 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
NDA #050796		 SUPPL-19 CEFTRIAXONE SODIUM B BRAUN Labeling Approval
07/09/2015 NIACIN
ANDA #200484		 SUPPL-1 NIACIN SUN PHARM Labeling Approval
07/09/2015 NIACIN
ANDA #201273		 SUPPL-1 NIACIN SUN PHARM Labeling Approval
07/09/2015 AMYVID
NDA #202008		 SUPPL-22 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
07/09/2015 AMYVID
NDA #202008		 SUPPL-24 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
07/09/2015 CALCIUM ACETATE
ANDA #202127		 ORIG-1 CALCIUM ACETATE LUPIN LTD Approval
07/09/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-2 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Labeling Approval
07/10/2015 BUPIVACAINE HYDROCHLORIDE
NDA #018053		 SUPPL-55 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/10/2015 SENSORCAINE
NDA #018304		 SUPPL-44 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
07/10/2015 SENSORCAINE
NDA #018304		 SUPPL-45 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
07/10/2015 SENSORCAINE
NDA #018304		 SUPPL-44 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Labeling Approval
07/10/2015 SENSORCAINE
NDA #018304		 SUPPL-45 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Labeling Approval
07/10/2015 OXYTROL
NDA #021351		 SUPPL-16 OXYBUTYNIN ALLERGAN Labeling Approval
07/10/2015 FOSAMAX PLUS D
NDA #021762		 SUPPL-19 ALENDRONATE SODIUM; CHOLECALCIFEROL ORGANON LLC Manufacturing (CMC) Approval
07/10/2015 GELNIQUE
NDA #022204		 SUPPL-9 OXYBUTYNIN CHLORIDE ABBVIE Labeling Approval
07/10/2015 SORILUX
NDA #022563		 SUPPL-4 CALCIPOTRIENE MAYNE PHARMA Manufacturing (CMC) Approval
07/10/2015 PROPAFENONE HYDROCHLORIDE
ANDA #078540		 SUPPL-4 PROPAFENONE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
07/10/2015 GELNIQUE 3%
NDA #202513		 SUPPL-5 OXYBUTYNIN ALLERGAN Labeling Approval
07/10/2015 KLOR-CON
ANDA #203106		 ORIG-1 POTASSIUM CHLORIDE UPSHER SMITH LABS Approval
07/10/2015 TRAVOPROST
ANDA #203431		 ORIG-1 TRAVOPROST APOTEX Approval
07/10/2015 NEVIRAPINE
ANDA #204621		 ORIG-1 NEVIRAPINE ALVOGEN Approval
07/10/2015 REXULTI
NDA #205422		 ORIG-1 BREXPIPRAZOLE OTSUKA Type 1 - New Molecular Entity Approval
07/10/2015 REXULTI
NDA #205422		 ORIG-2 BREXPIPRAZOLE OTSUKA Efficacy Approval
07/10/2015 ENVARSUS XR
NDA #206406		 ORIG-1 TACROLIMUS VELOXIS PHARMS INC Type 3 - New Dosage Form Approval
07/11/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #202433		 SUPPL-1 TAMSULOSIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/11/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #202433		 SUPPL-3 TAMSULOSIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/11/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #202433		 SUPPL-4 TAMSULOSIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/13/2015 FLAGYL
NDA #012623		 SUPPL-66 METRONIDAZOLE PFIZER Labeling Approval
07/13/2015 FLAGYL I.V.
NDA #018353		 SUPPL-27 METRONIDAZOLE HYDROCHLORIDE PFIZER Labeling Approval
07/13/2015 FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018353		 SUPPL-27 METRONIDAZOLE PFIZER Labeling Approval
07/13/2015 FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018657		 SUPPL-34 METRONIDAZOLE BAXTER HLTHCARE Labeling Approval
07/13/2015 METRONIDAZOLE IN PLASTIC CONTAINER
NDA #018890		 SUPPL-50 METRONIDAZOLE HOSPIRA Labeling Approval
07/13/2015 METRO I.V. IN PLASTIC CONTAINER
NDA #018900		 SUPPL-32 METRONIDAZOLE B BRAUN Labeling Approval
07/13/2015 FLAGYL
NDA #020334		 SUPPL-9 METRONIDAZOLE PFIZER Labeling Approval
07/13/2015 FLAGYL ER
NDA #020868		 SUPPL-11 METRONIDAZOLE PFIZER Labeling Approval
07/13/2015 CLEOCIN
NDA #050680		 SUPPL-11 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
07/13/2015 CLEOCIN
NDA #050767		 SUPPL-12 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
07/13/2015 NAPROXEN
ANDA #074201		 SUPPL-38 NAPROXEN TEVA Labeling Approval
07/13/2015 NAPROXEN
ANDA #074201		 SUPPL-39 NAPROXEN TEVA Labeling Approval
07/13/2015 NAPROXEN
ANDA #074201		 SUPPL-40 NAPROXEN TEVA Labeling Approval
07/13/2015 CLONIDINE HYDROCHLORIDE
ANDA #077901		 SUPPL-5 CLONIDINE HYDROCHLORIDE PRINSTON INC Labeling Approval
07/13/2015 CLOBETASOL PROPIONATE
ANDA #078854		 SUPPL-3 CLOBETASOL PROPIONATE ACTAVIS MID ATLANTIC Labeling Approval
07/13/2015 OLOPATADINE HYDROCHLORIDE
ANDA #090848		 ORIG-1 OLOPATADINE HYDROCHLORIDE BARR LABS INC Approval
07/13/2015 QUILLIVANT XR
NDA #202100		 SUPPL-5 METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE Labeling Approval
07/13/2015 TOBRAMYCIN
ANDA #205501		 ORIG-1 TOBRAMYCIN AMNEAL PHARMS Approval
07/13/2015 ONDANSETRON HYDROCHLORIDE
ANDA #206846		 ORIG-1 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Approval
07/13/2015 IRESSA
NDA #206995		 ORIG-1 GEFITINIB ASTRAZENECA Type 5 - New Formulation or New Manufacturer Approval
07/14/2015 LOTENSIN
NDA #019851		 SUPPL-48 BENAZEPRIL HYDROCHLORIDE VALIDUS PHARMS Manufacturing (CMC) Approval
07/14/2015 AGRYLIN
NDA #020333		 SUPPL-23 ANAGRELIDE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
07/14/2015 ZERIT
NDA #020412		 SUPPL-39 STAVUDINE BRISTOL Manufacturing (CMC) Approval
07/14/2015 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020488		 SUPPL-22 MAGNESIUM SULFATE HOSPIRA Manufacturing (CMC) Approval
07/14/2015 PEPCID COMPLETE
NDA #020958		 SUPPL-23 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
07/14/2015 NOXAFIL
NDA #022003		 SUPPL-16 POSACONAZOLE SCHERING Labeling Approval
07/14/2015 MIRALAX
NDA #022015		 SUPPL-22 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
07/14/2015 VALCYTE
NDA #022257		 SUPPL-6 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Manufacturing (CMC) Approval
07/14/2015 CEFACLOR
ANDA #065350		 SUPPL-6 CEFACLOR HIKMA Labeling Approval
07/14/2015 PANTOPRAZOLE SODIUM
ANDA #090296		 ORIG-1 PANTOPRAZOLE SODIUM SANDOZ Approval
07/14/2015 BIVALIRUDIN
ANDA #090811		 ORIG-1 BIVALIRUDIN HOSPIRA Approval
07/14/2015 BIVALIRUDIN
ANDA #090816		 ORIG-1 BIVALIRUDIN HOSPIRA Approval
07/14/2015 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-6 LEVETIRACETAM HQ SPCLT PHARMA Manufacturing (CMC) Approval
07/14/2015 TECFIDERA
NDA #204063		 SUPPL-12 DIMETHYL FUMARATE BIOGEN INC Manufacturing (CMC) Approval
07/14/2015 ZONTIVITY
NDA #204886		 SUPPL-1 VORAPAXAR SULFATE KEY THERAP Manufacturing (CMC) Approval
07/14/2015 AURYXIA
NDA #205874		 SUPPL-5 FERRIC CITRATE KERYX BIOPHARMS Manufacturing (CMC) Approval
07/14/2015 ORBACTIV
NDA #206334		 SUPPL-1 ORITAVANCIN DIPHOSPHATE MELINTA THERAP Manufacturing (CMC) Approval
07/14/2015 POTASSIUM CHLORIDE
NDA #206814		 SUPPL-1 POTASSIUM CHLORIDE GENUS LIFESCIENCES Manufacturing (CMC) Approval
07/15/2015 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-100 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/15/2015 TENORMIN
NDA #018240		 SUPPL-34 ATENOLOL TWI PHARMS Manufacturing (CMC) Approval
07/15/2015 HUMULIN N
BLA #018781		 SUPPL-157 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
07/15/2015 XYREM
NDA #021196		 SUPPL-23 SODIUM OXYBATE JAZZ PHARMS Labeling Approval
07/15/2015 CUBICIN
NDA #021572		 SUPPL-49 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
07/15/2015 CUBICIN RF
NDA #021572		 SUPPL-49 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
07/15/2015 DYLOJECT
NDA #022396		 SUPPL-1 DICLOFENAC SODIUM JAVELIN PHARMS INC Manufacturing (CMC) Approval
07/15/2015 TESTOSTERONE CYPIONATE
ANDA #040652		 SUPPL-7 TESTOSTERONE CYPIONATE RISING Labeling Approval
07/15/2015 CLINDAMYCIN PHOSPHATE
ANDA #065049		 SUPPL-13 CLINDAMYCIN PHOSPHATE PADAGIS US Labeling Approval
07/15/2015 KANAMYCIN SULFATE
ANDA #065111		 SUPPL-9 KANAMYCIN SULFATE FRESENIUS KABI USA Labeling Approval
07/15/2015 NORTRIPTYLINE HYDROCHLORIDE
ANDA #073556		 SUPPL-50 NORTRIPTYLINE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
07/15/2015 NORTRIPTYLINE HYDROCHLORIDE
ANDA #073556		 SUPPL-52 NORTRIPTYLINE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
07/15/2015 ETIDRONATE DISODIUM
ANDA #075800		 SUPPL-10 ETIDRONATE DISODIUM NORVIUM BIOSCIENCE Labeling Approval
07/15/2015 ETIDRONATE DISODIUM
ANDA #075800		 SUPPL-12 ETIDRONATE DISODIUM NORVIUM BIOSCIENCE Labeling Approval
07/15/2015 ECONAZOLE NITRATE
ANDA #076005		 SUPPL-6 ECONAZOLE NITRATE TARO Labeling Approval
07/15/2015 BETAMETHASONE DIPROPIONATE
ANDA #077477		 SUPPL-7 BETAMETHASONE DIPROPIONATE TARO Labeling Approval
07/15/2015 PAROXETINE HYDROCHLORIDE
ANDA #077873		 SUPPL-21 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
07/15/2015 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078020		 SUPPL-5 HYDROCHLOROTHIAZIDE; VALSARTAN MYLAN PHARMS INC Labeling Approval
07/15/2015 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078020		 SUPPL-7 HYDROCHLOROTHIAZIDE; VALSARTAN MYLAN PHARMS INC Labeling Approval
07/15/2015 NARATRIPTAN
ANDA #078751		 SUPPL-5 NARATRIPTAN HYDROCHLORIDE ANI PHARMS Labeling Approval
07/15/2015 GRANISETRON HYDROCHLORIDE
ANDA #078835		 SUPPL-13 GRANISETRON HYDROCHLORIDE SANDOZ INC Labeling Approval
07/15/2015 IBANDRONATE SODIUM
ANDA #078997		 SUPPL-2 IBANDRONATE SODIUM DR REDDYS LABS LTD Labeling Approval
07/15/2015 IBANDRONATE SODIUM
ANDA #078997		 SUPPL-3 IBANDRONATE SODIUM DR REDDYS LABS LTD Labeling Approval
07/15/2015 IBANDRONATE SODIUM
ANDA #078998		 SUPPL-2 IBANDRONATE SODIUM ORBION PHARMS Labeling Approval
07/15/2015 IBANDRONATE SODIUM
ANDA #078998		 SUPPL-3 IBANDRONATE SODIUM ORBION PHARMS Labeling Approval
07/15/2015 PAROXETINE HYDROCHLORIDE
ANDA #091427		 SUPPL-6 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
07/15/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091617		 SUPPL-2 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
07/15/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091617		 SUPPL-3 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
07/15/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091617		 SUPPL-4 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
07/15/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-4 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
07/15/2015 DYSPORT
BLA #125274		 SUPPL-102 abobotulinumtoxinA IPSEN BIOPHARM LTD Approval
07/15/2015 REPAGLINIDE AND METFORMIN HYDROCHLORIDE
ANDA #200624		 ORIG-1 METFORMIN HYDROCHLORIDE; REPAGLINIDE LUPIN LTD Approval
07/15/2015 QUININE SULFATE
ANDA #203729		 ORIG-1 QUININE SULFATE AMNEAL PHARMS Approval
07/15/2015 TIVORBEX
NDA #204768		 SUPPL-2 INDOMETHACIN GENUS Manufacturing (CMC) Approval
07/15/2015 ALEVE PM
NDA #205352		 SUPPL-4 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
07/15/2015 EPIDUO FORTE
NDA #207917		 ORIG-1 ADAPALENE; BENZOYL PEROXIDE GALDERMA LABS Type 5 - New Formulation or New Manufacturer Approval
07/16/2015 DROXIA
NDA #016295		 SUPPL-45 HYDROXYUREA CHEPLAPHARM Labeling Approval
07/16/2015 DROXIA
NDA #016295		 SUPPL-46 HYDROXYUREA CHEPLAPHARM Labeling Approval
07/16/2015 HYDREA
NDA #016295		 SUPPL-45 HYDROXYUREA CHEPLAPHARM Labeling Approval
07/16/2015 HYDREA
NDA #016295		 SUPPL-46 HYDROXYUREA CHEPLAPHARM Labeling Approval
07/16/2015 TENORMIN
NDA #018240		 SUPPL-35 ATENOLOL TWI PHARMS Manufacturing (CMC) Approval
07/16/2015 PLAVIX
NDA #020839		 SUPPL-61 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Labeling Approval
07/16/2015 PULMICORT FLEXHALER
NDA #021949		 SUPPL-10 BUDESONIDE CHEPLAPHARM Manufacturing (CMC) Approval
07/16/2015 CELLCEPT
NDA #050759		 SUPPL-39 MYCOPHENOLATE MOFETIL ROCHE PALO Manufacturing (CMC) Approval
07/16/2015 ALENDRONATE SODIUM
ANDA #075710		 SUPPL-12 ALENDRONATE SODIUM IMPAX LABS INC Labeling Approval
07/16/2015 ALENDRONATE SODIUM
ANDA #075710		 SUPPL-17 ALENDRONATE SODIUM IMPAX LABS INC Labeling Approval
07/16/2015 ALENDRONATE SODIUM
ANDA #076584		 SUPPL-12 ALENDRONATE SODIUM RISING Labeling Approval
07/16/2015 ALENDRONATE SODIUM
ANDA #076584		 SUPPL-14 ALENDRONATE SODIUM RISING Labeling Approval
07/16/2015 HYDROMORPHONE HYDROCHLORIDE
NDA #200403		 SUPPL-4 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Labeling Approval
07/16/2015 LINEZOLID
ANDA #200904		 ORIG-1 LINEZOLID SANDOZ Approval
07/16/2015 LINEZOLID
ANDA #200904		 ORIG-2 LINEZOLID SANDOZ Approval
07/16/2015 VITEKTA
NDA #203093		 SUPPL-1 ELVITEGRAVIR GILEAD SCIENCES INC Manufacturing (CMC) Approval
07/17/2015 LANTUS
BLA #021081		 SUPPL-63 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
07/17/2015 LANTUS SOLOSTAR
BLA #021081		 SUPPL-63 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
07/17/2015 LEXIVA
NDA #021548		 SUPPL-35 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
07/17/2015 LEXIVA
NDA #022116		 SUPPL-19 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
07/17/2015 AMPICILLIN SODIUM
ANDA #061395		 SUPPL-32 AMPICILLIN SODIUM SANDOZ Labeling Approval
07/17/2015 NIACIN
ANDA #090446		 SUPPL-4 NIACIN CHARTWELL RX Labeling Approval
07/17/2015 KRYSTEXXA
BLA #125293		 SUPPL-81 PEGLOTICASE HORIZON PHARMA Approval
07/17/2015 FLUDEOXYGLUCOSE F18
ANDA #204531		 ORIG-1 FLUDEOXYGLUCOSE F-18 UNIV MICHIGAN Approval
07/20/2015 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-37 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
07/20/2015 SODIUM CHLORIDE 0.9%
NDA #019635		 SUPPL-37 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
07/20/2015 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-37 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
07/20/2015 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-37 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
07/20/2015 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-37 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
07/20/2015 ARICEPT
NDA #020690		 SUPPL-39 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
07/20/2015 AZILECT
NDA #021641		 SUPPL-18 RASAGILINE MESYLATE TEVA Manufacturing (CMC) Approval
07/20/2015 ARICEPT ODT
NDA #021720		 SUPPL-12 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
07/20/2015 AK-FLUOR 10%
NDA #022186		 SUPPL-2 FLUORESCEIN SODIUM LONG GROVE PHARMS Manufacturing (CMC) Approval
07/20/2015 AK-FLUOR 25%
NDA #022186		 SUPPL-2 FLUORESCEIN SODIUM LONG GROVE PHARMS Manufacturing (CMC) Approval
07/20/2015 NESINA
NDA #022271		 SUPPL-6 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
07/20/2015 ARICEPT
NDA #022568		 SUPPL-8 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
07/20/2015 NAPROXEN
ANDA #075061		 SUPPL-27 NAPROXEN FOSUN PHARMA Labeling Approval
07/20/2015 GABAPENTIN
ANDA #076017		 SUPPL-38 GABAPENTIN IVAX SUB TEVA PHARMS Labeling Approval
07/20/2015 GABAPENTIN
ANDA #076017		 SUPPL-39 GABAPENTIN IVAX SUB TEVA PHARMS Labeling Approval
07/20/2015 CLARAVIS
ANDA #076135		 SUPPL-30 ISOTRETINOIN TEVA PHARMS USA Labeling Approval
07/20/2015 CLARAVIS
ANDA #076356		 SUPPL-27 ISOTRETINOIN TEVA PHARMS USA Labeling Approval
07/20/2015 AZATHIOPRINE
ANDA #077621		 SUPPL-8 AZATHIOPRINE ZYDUS PHARMS USA Labeling Approval
07/20/2015 TESTOSTERONE CYPIONATE
ANDA #086029		 SUPPL-88 TESTOSTERONE CYPIONATE WATSON LABS Labeling Approval
07/20/2015 BIMATOPROST
ANDA #090449		 ORIG-1 BIMATOPROST APOTEX Approval
07/20/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090686		 SUPPL-3 DONEPEZIL HYDROCHLORIDE TORRENT PHARMS Labeling Approval
07/20/2015 APREPITANT
ANDA #090999		 SUPPL-6 APREPITANT SANDOZ Labeling Approval
07/20/2015 APREPITANT
ANDA #090999		 SUPPL-8 APREPITANT SANDOZ Labeling Approval
07/20/2015 ACITRETIN
ANDA #091455		 SUPPL-2 ACITRETIN BARR LABS INC Labeling Approval
07/20/2015 ACITRETIN
ANDA #091455		 SUPPL-3 ACITRETIN BARR LABS INC Labeling Approval
07/20/2015 ACITRETIN
ANDA #091455		 SUPPL-4 ACITRETIN BARR LABS INC Labeling Approval
07/20/2015 ACITRETIN
ANDA #091455		 SUPPL-6 ACITRETIN BARR LABS INC Labeling Approval
07/20/2015 TRADJENTA
NDA #201280		 SUPPL-10 LINAGLIPTIN BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
07/20/2015 DONEPEZIL HYDROCHLORIDE
ANDA #202723		 SUPPL-1 DONEPEZIL HYDROCHLORIDE DR REDDYS Labeling Approval
07/20/2015 ACITRETIN
ANDA #202897		 SUPPL-2 ACITRETIN TEVA PHARMS USA Labeling Approval
07/20/2015 ACITRETIN
ANDA #202897		 SUPPL-3 ACITRETIN TEVA PHARMS USA Labeling Approval
07/20/2015 ACITRETIN
ANDA #202897		 SUPPL-4 ACITRETIN TEVA PHARMS USA Labeling Approval
07/20/2015 ACITRETIN
ANDA #202897		 SUPPL-6 ACITRETIN TEVA PHARMS USA Labeling Approval
07/20/2015 AKYNZEO
NDA #205718		 SUPPL-5 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Manufacturing (CMC) Approval
07/20/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-5 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Labeling Approval
07/21/2015 HEPARIN SODIUM
NDA #017029		 SUPPL-137 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/21/2015 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-137 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/21/2015 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-137 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/21/2015 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #017029		 SUPPL-137 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/21/2015 HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029		 SUPPL-137 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/21/2015 HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029		 SUPPL-137 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/21/2015 GLUCAGON
NDA #020928		 SUPPL-50 GLUCAGON LILLY Manufacturing (CMC) Approval
07/21/2015 ZIAGEN
NDA #020977		 SUPPL-29 ABACAVIR SULFATE VIIV HLTHCARE Manufacturing (CMC) Approval
07/21/2015 ABRAXANE
NDA #021660		 SUPPL-41 PACLITAXEL BRISTOL-MYERS Labeling Approval
07/21/2015 NEOMYCIN AND POLYMYXIN B SULFATE
ANDA #065106		 SUPPL-1 NEOMYCIN SULFATE; POLYMYXIN B SULFATE XGEN PHARMS Manufacturing (CMC) Approval
07/21/2015 PRAZOSIN HYDROCHLORIDE
ANDA #071745		 SUPPL-30 PRAZOSIN HYDROCHLORIDE TEVA PHARMS Labeling Approval
07/21/2015 PRAZOSIN HYDROCHLORIDE
ANDA #071745		 SUPPL-31 PRAZOSIN HYDROCHLORIDE TEVA PHARMS Labeling Approval
07/21/2015 PRAZOSIN HYDROCHLORIDE
ANDA #071994		 SUPPL-30 PRAZOSIN HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
07/21/2015 PRAZOSIN HYDROCHLORIDE
ANDA #071994		 SUPPL-31 PRAZOSIN HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
07/21/2015 PRAZOSIN HYDROCHLORIDE
ANDA #071995		 SUPPL-29 PRAZOSIN HYDROCHLORIDE TEVA PHARMS Labeling Approval
07/21/2015 PRAZOSIN HYDROCHLORIDE
ANDA #071995		 SUPPL-30 PRAZOSIN HYDROCHLORIDE TEVA PHARMS Labeling Approval
07/21/2015 EMVERM
ANDA #073580		 SUPPL-25 MEBENDAZOLE IMPAX LABS INC Labeling Approval
07/21/2015 PIOGLITAZONE HYDROCHLORIDE
ANDA #076801		 SUPPL-2 PIOGLITAZONE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
07/21/2015 TRANDOLAPRIL
ANDA #077522		 SUPPL-6 TRANDOLAPRIL LUPIN Labeling Approval
07/21/2015 TRANDOLAPRIL
ANDA #077522		 SUPPL-8 TRANDOLAPRIL LUPIN Labeling Approval
07/21/2015 TRANDOLAPRIL
ANDA #077522		 SUPPL-10 TRANDOLAPRIL LUPIN Labeling Approval
07/21/2015 RIVASTIGMINE TARTRATE
ANDA #091072		 SUPPL-2 RIVASTIGMINE TARTRATE APOTEX INC Labeling Approval
07/21/2015 RIVASTIGMINE TARTRATE
ANDA #091072		 SUPPL-6 RIVASTIGMINE TARTRATE APOTEX INC Labeling Approval
07/21/2015 PIOGLITAZONE HYDROCHLORIDE
ANDA #200044		 SUPPL-1 PIOGLITAZONE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
07/21/2015 PIOGLITAZONE HYDROCHLORIDE
ANDA #200268		 SUPPL-3 PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/21/2015 XTANDI
NDA #203415		 SUPPL-5 ENZALUTAMIDE ASTELLAS Efficacy Approval
07/21/2015 SODIUM FLUORIDE F-18
ANDA #204517		 ORIG-1 SODIUM FLUORIDE F-18 MIPS CRF Approval
07/21/2015 AURYXIA
NDA #205874		 SUPPL-4 FERRIC CITRATE KERYX BIOPHARMS Labeling Approval
07/22/2015 LOTENSIN
NDA #019851		 SUPPL-45 BENAZEPRIL HYDROCHLORIDE VALIDUS PHARMS Labeling Approval
07/22/2015 LOTENSIN
NDA #019851		 SUPPL-49 BENAZEPRIL HYDROCHLORIDE VALIDUS PHARMS Labeling Approval
07/22/2015 BONIVA
NDA #021858		 SUPPL-21 IBANDRONATE SODIUM ROCHE Manufacturing (CMC) Approval
07/22/2015 RIVASTIGMINE TARTRATE
ANDA #077130		 SUPPL-1 RIVASTIGMINE TARTRATE DR REDDYS LABS INC Labeling Approval
07/22/2015 RIVASTIGMINE TARTRATE
ANDA #077130		 SUPPL-2 RIVASTIGMINE TARTRATE DR REDDYS LABS INC Labeling Approval
07/22/2015 IBANDRONATE SODIUM
ANDA #078996		 SUPPL-1 IBANDRONATE SODIUM SUN PHARM INDUSTRIES Labeling Approval
07/22/2015 IBANDRONATE SODIUM
ANDA #078996		 SUPPL-3 IBANDRONATE SODIUM SUN PHARM INDUSTRIES Labeling Approval
07/22/2015 IBANDRONATE SODIUM
ANDA #078996		 SUPPL-4 IBANDRONATE SODIUM SUN PHARM INDUSTRIES Labeling Approval
07/22/2015 TESTOSTERONE CYPIONATE
ANDA #086030		 SUPPL-49 TESTOSTERONE CYPIONATE WATSON PHARMS INC Labeling Approval
07/22/2015 ALENDRONATE SODIUM
ANDA #090124		 SUPPL-9 ALENDRONATE SODIUM AUROBINDO PHARMA Labeling Approval
07/22/2015 ALENDRONATE SODIUM
ANDA #090124		 SUPPL-10 ALENDRONATE SODIUM AUROBINDO PHARMA Labeling Approval
07/22/2015 ALENDRONATE SODIUM
ANDA #090124		 SUPPL-12 ALENDRONATE SODIUM AUROBINDO PHARMA Labeling Approval
07/22/2015 NALTREXONE HYDROCHLORIDE
ANDA #090356		 SUPPL-3 NALTREXONE HYDROCHLORIDE SUN PHARM Labeling Approval
07/22/2015 TESTOSTERONE CYPIONATE
ANDA #091244		 SUPPL-6 TESTOSTERONE CYPIONATE HIKMA FARMACEUTICA Labeling Approval
07/22/2015 MEROPENEM
ANDA #091404		 SUPPL-4 MEROPENEM ACS DOBFAR Labeling Approval
07/22/2015 MEROPENEM
ANDA #091404		 SUPPL-8 MEROPENEM ACS DOBFAR Labeling Approval
07/22/2015 MEROPENEM
ANDA #091404		 SUPPL-10 MEROPENEM ACS DOBFAR Labeling Approval
07/22/2015 MEROPENEM
ANDA #091404		 SUPPL-11 MEROPENEM ACS DOBFAR Labeling Approval
07/22/2015 KORLYM
NDA #202107		 SUPPL-5 MIFEPRISTONE CORCEPT THERAP Manufacturing (CMC) Approval
07/22/2015 QUININE SULFATE
ANDA #204372		 ORIG-1 QUININE SULFATE NOVAST LABS Approval
07/22/2015 TAYTULLA
NDA #204426		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
07/22/2015 ZYKADIA
NDA #205755		 SUPPL-3 CERITINIB NOVARTIS Labeling Approval
07/22/2015 ZYKADIA
NDA #205755		 SUPPL-4 CERITINIB NOVARTIS Labeling Approval
07/23/2015 ZYPREXA
NDA #020592		 SUPPL-64 OLANZAPINE CHEPLAPHARM Labeling Approval
07/23/2015 ZYPREXA ZYDIS
NDA #021086		 SUPPL-42 OLANZAPINE CHEPLAPHARM Labeling Approval
07/23/2015 ZYPREXA
NDA #021253		 SUPPL-49 OLANZAPINE CHEPLAPHARM Labeling Approval
07/23/2015 EXJADE
NDA #021882		 SUPPL-21 DEFERASIROX NOVARTIS Labeling Approval
07/23/2015 ZYPREXA RELPREVV
NDA #022173		 SUPPL-17 OLANZAPINE PAMOATE CHEPLAPHARM Labeling Approval
07/23/2015 DUAVEE
NDA #022247		 SUPPL-1 BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED WYETH PHARMS Labeling Approval
07/23/2015 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #072854		 SUPPL-23 CYCLOBENZAPRINE HYDROCHLORIDE AIPING PHARM INC Labeling Approval
07/23/2015 ANASTROZOLE
ANDA #078058		 SUPPL-7 ANASTROZOLE TEVA PHARMS Labeling Approval
07/23/2015 ANASTROZOLE
ANDA #078058		 SUPPL-8 ANASTROZOLE TEVA PHARMS Labeling Approval
07/23/2015 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091568		 SUPPL-2 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
07/23/2015 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091569		 SUPPL-2 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
07/23/2015 ARANESP
BLA #103951		 SUPPL-5363 DARBEPOETIN ALFA AMGEN Approval
07/23/2015 PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
ANDA #201049		 SUPPL-4 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE SANDOZ Labeling Approval
07/23/2015 PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
ANDA #201049		 SUPPL-5 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE SANDOZ Labeling Approval
07/23/2015 AMLODIPINE BESYLATE
ANDA #204900		 ORIG-1 AMLODIPINE BESYLATE SOVEREIGN PHARMS Approval
07/23/2015 ESMOLOL HYDROCHLORIDE
ANDA #205520		 ORIG-1 ESMOLOL HYDROCHLORIDE EUGIA PHARMA Approval
07/23/2015 EVOTAZ
NDA #206353		 SUPPL-1 ATAZANAVIR SULFATE; COBICISTAT BRISTOL Labeling Approval
07/24/2015 ALFENTA
NDA #019353		 SUPPL-19 ALFENTANIL HYDROCHLORIDE RISING Labeling Approval
07/24/2015 LOTRONEX
NDA #021107		 SUPPL-25 ALOSETRON HYDROCHLORIDE SEBELA IRELAND LTD REMS Approval
07/24/2015 CEFACLOR
ANDA #065058		 SUPPL-9 CEFACLOR TEVA Labeling Approval
07/24/2015 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-36 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
07/24/2015 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-38 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
07/24/2015 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-41 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
07/24/2015 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-42 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
07/24/2015 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-44 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
07/24/2015 ARIPIPRAZOLE
ANDA #078583		 ORIG-1 ARIPIPRAZOLE APOTEX Approval
07/24/2015 IBANDRONATE SODIUM
ANDA #078948		 SUPPL-2 IBANDRONATE SODIUM APOTEX INC Labeling Approval
07/24/2015 IBANDRONATE SODIUM
ANDA #078948		 SUPPL-5 IBANDRONATE SODIUM APOTEX INC Labeling Approval
07/24/2015 IBANDRONATE SODIUM
ANDA #078948		 SUPPL-6 IBANDRONATE SODIUM APOTEX INC Labeling Approval
07/24/2015 PRALUENT
BLA #125559		 ORIG-1 ALIROCUMAB REGENERON PHARMACEUTICALS Approval
07/24/2015 OXCARBAZEPINE
ANDA #201193		 SUPPL-1 OXCARBAZEPINE HIKMA Labeling Approval
07/24/2015 OXCARBAZEPINE
ANDA #201193		 SUPPL-3 OXCARBAZEPINE HIKMA Labeling Approval
07/24/2015 NIMODIPINE
ANDA #201832		 ORIG-1 NIMODIPINE SOFGEN PHARMS Approval
07/24/2015 KYPROLIS
NDA #202714		 SUPPL-9 CARFILZOMIB ONYX PHARMS AMGEN Efficacy Approval
07/24/2015 NIACIN
ANDA #203578		 ORIG-1 NIACIN AMNEAL PHARMS Approval
07/24/2015 ODOMZO
NDA #205266		 ORIG-1 SONIDEGIB PHOSPHATE SUN PHARM Type 1 - New Molecular Entity Approval
07/24/2015 DIFLORASONE DIACETATE
ANDA #206572		 ORIG-1 DIFLORASONE DIACETATE SAPTALIS PHARMS Approval
07/24/2015 DAKLINZA
NDA #206843		 ORIG-1 DACLATASVIR DIHYDROCHLORIDE BRISTOL-MYERS SQUIBB Type 1 - New Molecular Entity Approval
07/24/2015 TECHNIVIE
NDA #207931		 ORIG-1 OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE Type 5 - New Formulation or New Manufacturer Approval
07/27/2015 ZIAC
NDA #020186		 SUPPL-32 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/27/2015 DIOVAN
NDA #020665		 SUPPL-38 VALSARTAN NOVARTIS Labeling Approval
07/27/2015 DIOVAN HCT
NDA #020818		 SUPPL-66 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
07/27/2015 DIOVAN
NDA #021283		 SUPPL-46 VALSARTAN NOVARTIS Labeling Approval
07/27/2015 BRAVELLE
BLA #021289		 SUPPL-26 UROFOLLITROPIN FERRING Approval
07/27/2015 HYLENEX RECOMBINANT
BLA #021859		 SUPPL-22 HYALURONIDASE RECOMBINANT HUMAN HALOZYME THERAP Approval
07/27/2015 FERAHEME
NDA #022180		 SUPPL-12 FERUMOXYTOL COVIS Manufacturing (CMC) Approval
07/27/2015 EXPAREL
NDA #022496		 SUPPL-14 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
07/27/2015 CLARITHROMYCIN
ANDA #065384		 SUPPL-7 CLARITHROMYCIN CHARTWELL Labeling Approval
07/27/2015 CLARITHROMYCIN
ANDA #065384		 SUPPL-8 CLARITHROMYCIN CHARTWELL Labeling Approval
07/27/2015 CLARITHROMYCIN
ANDA #065384		 SUPPL-9 CLARITHROMYCIN CHARTWELL Labeling Approval
07/27/2015 MOMETASONE FUROATE
ANDA #077180		 SUPPL-4 MOMETASONE FUROATE PADAGIS ISRAEL Labeling Approval
07/27/2015 PIOGLITAZONE HYDROCHLORIDE
ANDA #091298		 SUPPL-3 PIOGLITAZONE HYDROCHLORIDE TORRENT PHARMS LTD Labeling Approval
07/27/2015 TANZEUM
BLA #125431		 SUPPL-14 ALBIGLUTIDE GLAXOSMITHKLINE LLC Approval
07/27/2015 TRULICITY
BLA #125469		 SUPPL-4 DULAGLUTIDE ELI LILLY AND CO Approval
07/27/2015 VITEKTA
NDA #203093		 SUPPL-2 ELVITEGRAVIR GILEAD SCIENCES INC Labeling Approval
07/27/2015 RAVICTI
NDA #203284		 SUPPL-3 GLYCEROL PHENYLBUTYRATE HORIZON THERAP US Manufacturing (CMC) Approval
07/27/2015 LITHIUM CARBONATE
ANDA #204779		 ORIG-1 LITHIUM CARBONATE UNIQUE Approval
07/28/2015 8-MOP
NDA #009048		 SUPPL-47 METHOXSALEN VALEANT PHARM INTL Manufacturing (CMC) Approval
07/28/2015 OXSORALEN
NDA #009048		 SUPPL-47 METHOXSALEN VALEANT PHARM INTL Manufacturing (CMC) Approval
07/28/2015 LANOXIN
NDA #009330		 SUPPL-30 DIGOXIN COVIS Labeling Approval
07/28/2015 LANOXIN PEDIATRIC
NDA #009330		 SUPPL-30 DIGOXIN COVIS Labeling Approval
07/28/2015 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #020178		 SUPPL-15 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/28/2015 LANOXIN
NDA #020405		 SUPPL-11 DIGOXIN CONCORDIA Labeling Approval
07/28/2015 CHIRHOSTIM
NDA #021256		 SUPPL-12 SECRETIN SYNTHETIC HUMAN CHIRHOCLIN Manufacturing (CMC) Approval
07/28/2015 DIGOXIN
NDA #021648		 SUPPL-8 DIGOXIN HIKMA Labeling Approval
07/28/2015 EXFORGE
NDA #021990		 SUPPL-26 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Labeling Approval
07/28/2015 EXFORGE HCT
NDA #022314		 SUPPL-20 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
07/28/2015 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #071402		 SUPPL-12 METOCLOPRAMIDE HYDROCHLORIDE ANI PHARMS Labeling Approval
07/28/2015 FLUVOXAMINE MALEATE
ANDA #075902		 SUPPL-18 FLUVOXAMINE MALEATE APOTEX Labeling Approval
07/28/2015 FLUVOXAMINE MALEATE
ANDA #075902		 SUPPL-20 FLUVOXAMINE MALEATE APOTEX Labeling Approval
07/28/2015 CHLORHEXIDINE GLUCONATE
ANDA #077789		 SUPPL-7 CHLORHEXIDINE GLUCONATE XTTRIUM Labeling Approval
07/28/2015 AZELASTINE HYDROCHLORIDE
ANDA #090176		 ORIG-1 AZELASTINE HYDROCHLORIDE BIONPHARMA Approval
07/28/2015 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-4 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Manufacturing (CMC) Approval
07/28/2015 TRADJENTA
NDA #201280		 SUPPL-11 LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
07/28/2015 JENTADUETO
NDA #201281		 SUPPL-8 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
07/28/2015 STRIBILD
NDA #203100		 SUPPL-16 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
07/28/2015 KYNAMRO
NDA #203568		 SUPPL-5 MIPOMERSEN SODIUM KASTLE THERAPS LLC REMS Approval
07/28/2015 FOLIC ACID
ANDA #204418		 ORIG-1 FOLIC ACID NUVO PHARMS INC Approval
07/28/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #206586		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE ENDO OPERATIONS Approval
07/29/2015 PERSANTINE
NDA #012836		 SUPPL-60 DIPYRIDAMOLE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
07/29/2015 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-120 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-121 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/29/2015 TARGRETIN
NDA #021055		 SUPPL-10 BEXAROTENE VALEANT LUXEMBOURG Efficacy Approval
07/29/2015 FLUVOXAMINE MALEATE
ANDA #075888		 SUPPL-32 FLUVOXAMINE MALEATE UPSHER SMITH LABS Labeling Approval
07/29/2015 FLUVOXAMINE MALEATE
ANDA #075888		 SUPPL-36 FLUVOXAMINE MALEATE UPSHER SMITH LABS Labeling Approval
07/29/2015 ABILIFY MAINTENA KIT
NDA #202971		 SUPPL-6 ARIPIPRAZOLE OTSUKA PHARM CO LTD Efficacy Approval
07/29/2015 NEBIVOLOL HYDROCHLORIDE
ANDA #203828		 ORIG-1 NEBIVOLOL HYDROCHLORIDE INDCHEMIE HEALTH Approval
07/29/2015 SODIUM FLUORIDE F-18
ANDA #204530		 ORIG-1 SODIUM FLUORIDE F-18 HOT SHOTS NM LLC Approval
07/29/2015 ETHACRYNATE SODIUM
ANDA #205473		 ORIG-1 ETHACRYNATE SODIUM ENDO OPERATIONS Approval
07/29/2015 FINACEA
NDA #207071		 ORIG-1 AZELAIC ACID LEO PHARMA AS Type 3 - New Dosage Form Approval
07/30/2015 8-MOP
NDA #009048		 SUPPL-48 METHOXSALEN VALEANT PHARM INTL Manufacturing (CMC) Approval
07/30/2015 OXSORALEN
NDA #009048		 SUPPL-48 METHOXSALEN VALEANT PHARM INTL Manufacturing (CMC) Approval
07/30/2015 VALIUM
NDA #013263		 SUPPL-93 DIAZEPAM WAYLIS THERAP Manufacturing (CMC) Approval
07/30/2015 NAPROSYN
NDA #018965		 SUPPL-21 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
07/30/2015 BIO-TROPIN
BLA #019774		 SUPPL-32 SOMATROPIN FERRING Approval
07/30/2015 ZOMACTON
BLA #019774		 SUPPL-32 SOMATROPIN FERRING Approval
07/30/2015 ETOPOPHOS PRESERVATIVE FREE
NDA #020457		 SUPPL-14 ETOPOSIDE PHOSPHATE CHEPLAPHARM Labeling Approval
07/30/2015 PLETAL
NDA #020863		 SUPPL-23 CILOSTAZOL OTSUKA Labeling Approval
07/30/2015 BENZONATATE
ANDA #091133		 ORIG-1 BENZONATATE STRIDES PHARMA Approval
07/30/2015 NEUPOGEN
BLA #103353		 SUPPL-5186 FILGRASTIM AMGEN Approval
07/30/2015 KRYSTEXXA
BLA #125293		 SUPPL-83 PEGLOTICASE HORIZON PHARMA Approval
07/30/2015 EYLEA
BLA #125387		 SUPPL-36 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
07/30/2015 LATUDA
NDA #200603		 SUPPL-20 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Manufacturing (CMC) Approval
07/30/2015 SODIUM FLUORIDE F-18
ANDA #203780		 ORIG-1 SODIUM FLUORIDE F-18 CARDINAL HEALTH 414 Approval
07/30/2015 OMEPRAZOLE MAGNESIUM
ANDA #204152		 ORIG-1 OMEPRAZOLE MAGNESIUM PERRIGO R AND D Approval
07/30/2015 TIVICAY
NDA #204790		 SUPPL-4 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
07/30/2015 PROAIR DIGIHALER
NDA #205636		 SUPPL-1 ALBUTEROL SULFATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/30/2015 PROAIR DIGIHALER
NDA #205636		 SUPPL-2 ALBUTEROL SULFATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/30/2015 PROAIR RESPICLICK
NDA #205636		 SUPPL-1 ALBUTEROL SULFATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/30/2015 PROAIR RESPICLICK
NDA #205636		 SUPPL-2 ALBUTEROL SULFATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/30/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-4 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Manufacturing (CMC) Approval
07/31/2015 ROBINUL
NDA #012827		 SUPPL-56 GLYCOPYRROLATE CASPER PHARMA LLC Manufacturing (CMC) Approval
07/31/2015 ROBINUL FORTE
NDA #012827		 SUPPL-56 GLYCOPYRROLATE CASPER PHARMA LLC Manufacturing (CMC) Approval
07/31/2015 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017585		 SUPPL-142 DEXTROSE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2015 DDAVP
NDA #017922		 SUPPL-44 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
07/31/2015 DDAVP (NEEDS NO REFRIGERATION)
NDA #017922		 SUPPL-44 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
07/31/2015 MOTRIN IB
NDA #019012		 SUPPL-53 IBUPROFEN J AND J CONSUMER INC Manufacturing (CMC) Approval
07/31/2015 MOTRIN MIGRAINE PAIN
NDA #019012		 SUPPL-53 IBUPROFEN J AND J CONSUMER INC Manufacturing (CMC) Approval
07/31/2015 NUPRIN
NDA #019012		 SUPPL-53 IBUPROFEN J AND J CONSUMER INC Manufacturing (CMC) Approval
07/31/2015 NAPHCON-A
NDA #020226		 SUPPL-24 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE ALCON Manufacturing (CMC) Approval
07/31/2015 FIORICET W/ CODEINE
NDA #020232		 SUPPL-39 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/31/2015 COSOPT
NDA #020869		 SUPPL-40 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE THEA PHARMA Labeling Approval
07/31/2015 NATRECOR
NDA #020920		 SUPPL-35 NESIRITIDE SCIOS LLC Manufacturing (CMC) Approval
07/31/2015 MAGNEVIST
NDA #021037		 SUPPL-31 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Labeling Approval
07/31/2015 RAPAMUNE
NDA #021083		 SUPPL-57 SIROLIMUS PF PRISM CV Manufacturing (CMC) Approval
07/31/2015 ORTHO TRI-CYCLEN LO
NDA #021241		 SUPPL-25 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
07/31/2015 DIOVAN
NDA #021283		 SUPPL-47 VALSARTAN NOVARTIS Manufacturing (CMC) Approval
07/31/2015 HICON
NDA #021305		 SUPPL-40 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
07/31/2015 SODIUM IODIDE I 131
NDA #021305		 SUPPL-40 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
07/31/2015 YAZ
NDA #021676		 SUPPL-17 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
07/31/2015 VANTAS
NDA #021732		 SUPPL-20 HISTRELIN ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
07/31/2015 FIRMAGON
NDA #022201		 SUPPL-10 DEGARELIX ACETATE FERRING Manufacturing (CMC) Approval
07/31/2015 NALOXONE HYDROCHLORIDE
ANDA #072076		 SUPPL-19 NALOXONE HYDROCHLORIDE INTL MEDICATION Labeling Approval
07/31/2015 METOPROLOL TARTRATE
ANDA #074141		 SUPPL-35 METOPROLOL TARTRATE HERITAGE PHARMA Labeling Approval
07/31/2015 ATENOLOL AND CHLORTHALIDONE
ANDA #074203		 SUPPL-23 ATENOLOL; CHLORTHALIDONE AUROBINDO PHARMA USA Labeling Approval
07/31/2015 PENTOXIFYLLINE
ANDA #075191		 SUPPL-13 PENTOXIFYLLINE APOTEX Labeling Approval
07/31/2015 PENTOXIFYLLINE
ANDA #075191		 SUPPL-14 PENTOXIFYLLINE APOTEX Labeling Approval
07/31/2015 PENTOXIFYLLINE
ANDA #075191		 SUPPL-16 PENTOXIFYLLINE APOTEX Labeling Approval
07/31/2015 FLUOXETINE HYDROCHLORIDE
ANDA #076287		 SUPPL-6 FLUOXETINE HYDROCHLORIDE ANI PHARMS Labeling Approval
07/31/2015 MOMETASONE FUROATE
ANDA #076679		 SUPPL-11 MOMETASONE FUROATE TARO Labeling Approval
07/31/2015 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #077209		 SUPPL-3 CYCLOBENZAPRINE HYDROCHLORIDE OXFORD PHARMS Labeling Approval
07/31/2015 FLUOXETINE HYDROCHLORIDE
ANDA #077469		 SUPPL-11 FLUOXETINE HYDROCHLORIDE SANDOZ Labeling Approval
07/31/2015 FLUOXETINE HYDROCHLORIDE
ANDA #078045		 SUPPL-7 FLUOXETINE HYDROCHLORIDE NATCO PHARMA USA Labeling Approval
07/31/2015 MEMANTINE HYDROCHLORIDE
ANDA #090043		 ORIG-1 MEMANTINE HYDROCHLORIDE UPSHER SMITH LABS Approval
07/31/2015 GADAVIST
NDA #201277		 SUPPL-10 GADOBUTROL BAYER HLTHCARE Labeling Approval
07/31/2015 LORATADINE
ANDA #201865		 ORIG-1 LORATADINE TARO Approval
07/31/2015 BENZONATATE
ANDA #202765		 ORIG-1 BENZONATATE CSPC-NBP PHARM Approval
07/31/2015 MONTELUKAST SODIUM
ANDA #203328		 ORIG-1 MONTELUKAST SODIUM AJANTA PHARMA LTD Approval
07/31/2015 ALPRAZOLAM
ANDA #203346		 ORIG-1 ALPRAZOLAM AUROBINDO PHARMA Approval
07/31/2015 MONTELUKAST SODIUM
ANDA #203432		 ORIG-1 MONTELUKAST SODIUM AJANTA PHARMA LTD Approval
07/31/2015 MONTELUKAST SODIUM
ANDA #203438		 ORIG-1 MONTELUKAST SODIUM AJANTA PHARMA LTD Approval
07/31/2015 NEOSTIGMINE METHYLSULFATE
NDA #203629		 SUPPL-1 NEOSTIGMINE METHYLSULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
07/31/2015 RABEPRAZOLE SODIUM
ANDA #204179		 ORIG-1 RABEPRAZOLE SODIUM AMNEAL PHARMS Approval
07/31/2015 SPRITAM
NDA #207958		 ORIG-1 LEVETIRACETAM APRECIA PHARMS Type 3 - New Dosage Form Approval
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