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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 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 14, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/01/2013 SOMA
NDA #011792		 SUPPL-45 CARISOPRODOL MYLAN SPECIALITY LP Labeling Approval
02/01/2013 RETIN-A
NDA #017955		 SUPPL-31 TRETINOIN BAUSCH Manufacturing (CMC) Approval
02/01/2013 LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-18 LIDOCAINE HYDROCHLORIDE B BRAUN Labeling Approval
02/01/2013 LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-18 LIDOCAINE HYDROCHLORIDE B BRAUN Labeling Approval
02/01/2013 LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-18 LIDOCAINE HYDROCHLORIDE B BRAUN Labeling Approval
02/01/2013 ZOLOFT
NDA #019839		 SUPPL-79 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
02/01/2013 NITROGLYCERIN IN DEXTROSE 5%
NDA #019970		 SUPPL-12 NITROGLYCERIN BAXTER HLTHCARE Manufacturing (CMC) Approval
02/01/2013 FERRLECIT
NDA #020955		 SUPPL-16 SODIUM FERRIC GLUCONATE COMPLEX SANOFI AVENTIS US Manufacturing (CMC) Approval
02/01/2013 ZOLOFT
NDA #020990		 SUPPL-38 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
02/01/2013 BENICAR
NDA #021286		 SUPPL-24 OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
02/01/2013 BENICAR HCT
NDA #021532		 SUPPL-19 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
02/01/2013 PREZISTA
NDA #021976		 SUPPL-28 DARUNAVIR JANSSEN PRODS Efficacy Approval
02/01/2013 PREZISTA
NDA #021976		 SUPPL-29 DARUNAVIR JANSSEN PRODS Efficacy Approval
02/01/2013 AZOR
NDA #022100		 SUPPL-18 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
02/01/2013 VIBATIV
NDA #022110		 SUPPL-4 TELAVANCIN HYDROCHLORIDE CUMBERLAND Manufacturing (CMC) Approval
02/01/2013 SELZENTRY
NDA #022128		 SUPPL-10 MARAVIROC VIIV HLTHCARE Labeling Approval
02/01/2013 EPIDUO
NDA #022320		 SUPPL-4 ADAPALENE; BENZOYL PEROXIDE GALDERMA LABS LP Efficacy Approval
02/01/2013 VALACYCLOVIR HYDROCHLORIDE
ANDA #077478		 SUPPL-8 VALACYCLOVIR HYDROCHLORIDE AIPING PHARM INC Labeling Approval
02/01/2013 NEVIRAPINE
ANDA #077521		 SUPPL-12 NEVIRAPINE AUROBINDO Labeling Approval
02/01/2013 TRIBENZOR
NDA #200175		 SUPPL-10 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
02/01/2013 ZIDOVUDINE
ANDA #202058		 SUPPL-2 ZIDOVUDINE HEC PHARM Labeling Approval
02/01/2013 PREZISTA
NDA #202895		 SUPPL-5 DARUNAVIR JANSSEN PRODS Efficacy Approval
02/01/2013 PREZISTA
NDA #202895		 SUPPL-6 DARUNAVIR JANSSEN PRODS Efficacy Approval
02/01/2013 RAVICTI
NDA #203284		 ORIG-1 GLYCEROL PHENYLBUTYRATE HORIZON THERAP US Type 2 - New Active Ingredient Approval
02/01/2013 DELZICOL
NDA #204412		 ORIG-1 MESALAMINE ABBVIE Type 3 - New Dosage Form Approval
02/04/2013 ADVIL PM
NDA #021393		 SUPPL-12 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
02/04/2013 EOVIST
NDA #022090		 SUPPL-3 GADOXETATE DISODIUM BAYER HLTHCARE Manufacturing (CMC) Approval
02/04/2013 NEVIRAPINE
ANDA #077702		 SUPPL-7 NEVIRAPINE AUROBINDO Manufacturing (CMC) Approval
02/04/2013 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #203263		 ORIG-1 DOXORUBICIN HYDROCHLORIDE SUN PHARM Approval
02/05/2013 DEFINITY
NDA #021064		 SUPPL-16 PERFLUTREN LANTHEUS MEDCL Manufacturing (CMC) Approval
02/05/2013 DEFINITY RT
NDA #021064		 SUPPL-16 PERFLUTREN LANTHEUS MEDCL Manufacturing (CMC) Approval
02/05/2013 TRICOR
NDA #021656		 SUPPL-23 FENOFIBRATE ABBVIE Labeling Approval
02/05/2013 VIMPAT
NDA #022253		 SUPPL-21 LACOSAMIDE UCB INC Labeling Approval
02/05/2013 VIMPAT
NDA #022254		 SUPPL-14 LACOSAMIDE UCB INC Labeling Approval
02/05/2013 VIMPAT
NDA #022255		 SUPPL-8 LACOSAMIDE UCB INC Labeling Approval
02/05/2013 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #040632		 SUPPL-6 METHOTREXATE SODIUM HIKMA Labeling Approval
02/05/2013 DEMECLOCYCLINE HYDROCHLORIDE
ANDA #065425		 SUPPL-2 DEMECLOCYCLINE HYDROCHLORIDE AMNEAL PHARM Labeling Approval
02/05/2013 INDAPAMIDE
ANDA #074722		 SUPPL-27 INDAPAMIDE ACTAVIS ELIZABETH Labeling Approval
02/05/2013 PRAVASTATIN SODIUM
ANDA #076056		 SUPPL-13 PRAVASTATIN SODIUM AUROBINDO PHARMA USA Labeling Approval
02/05/2013 PRAVASTATIN SODIUM
ANDA #077793		 SUPPL-5 PRAVASTATIN SODIUM AUROBINDO PHARMA USA Labeling Approval
02/05/2013 TERBINAFINE HYDROCHLORIDE
ANDA #078297		 SUPPL-10 TERBINAFINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
02/05/2013 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #086513		 SUPPL-68 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE MYLAN Labeling Approval
02/05/2013 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089340		 SUPPL-32 METHOTREXATE SODIUM HIKMA Labeling Approval
02/05/2013 METHOTREXATE SODIUM
ANDA #089341		 SUPPL-32 METHOTREXATE SODIUM HIKMA Labeling Approval
02/05/2013 METHOTREXATE SODIUM
ANDA #089342		 SUPPL-32 METHOTREXATE SODIUM HIKMA Labeling Approval
02/05/2013 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089343		 SUPPL-32 METHOTREXATE SODIUM HIKMA Labeling Approval
02/05/2013 ALENDRONATE SODIUM
ANDA #090124		 SUPPL-7 ALENDRONATE SODIUM AUROBINDO PHARMA Labeling Approval
02/05/2013 MEFENAMIC ACID
ANDA #090359		 ORIG-1 MEFENAMIC ACID MPP PHARMA Approval
02/05/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090385		 SUPPL-2 LEVOCETIRIZINE DIHYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
02/05/2013 BENZTROPINE MESYLATE
ANDA #091525		 ORIG-1 BENZTROPINE MESYLATE NAVINTA LLC Approval
02/05/2013 MONTELUKAST SODIUM
ANDA #201581		 SUPPL-2 MONTELUKAST SODIUM SENORES PHARMS Labeling Approval
02/05/2013 MONTELUKAST SODIUM
ANDA #201582		 SUPPL-2 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
02/05/2013 POLYETHYLENE GLYCOL 3350
ANDA #202071		 SUPPL-1 POLYETHYLENE GLYCOL 3350 SHREE HARI INTL Labeling Approval
02/05/2013 CALCIUM ACETATE
ANDA #202420		 ORIG-1 CALCIUM ACETATE CHARTWELL MOLECULAR Approval
02/06/2013 FENTANYL CITRATE
NDA #019101		 SUPPL-37 FENTANYL CITRATE HIKMA Labeling Approval
02/06/2013 GONAL-F
BLA #020378		 SUPPL-50 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/06/2013 MONISTAT 3 COMBINATION PACK
NDA #020670		 SUPPL-21 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/06/2013 REBETOL
NDA #020903		 SUPPL-50 RIBAVIRIN MERCK SHARP DOHME Labeling Approval
02/06/2013 MONISTAT DUAL- PAK
NDA #020968		 SUPPL-2 MICONAZOLE NITRATE PERSONAL PRODS Manufacturing (CMC) Approval
02/06/2013 CANASA
NDA #021252		 SUPPL-13 MESALAMINE ABBVIE Labeling Approval
02/06/2013 MONISTAT 1 COMBINATION PACK
NDA #021308		 SUPPL-18 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/06/2013 COPEGUS
NDA #021511		 SUPPL-26 RIBAVIRIN ROCHE Labeling Approval
02/06/2013 REBETOL
NDA #021546		 SUPPL-6 RIBAVIRIN SCHERING Labeling Approval
02/06/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-23 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/06/2013 GONAL-F
BLA #021765		 SUPPL-20 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/06/2013 GONAL-F RFF
BLA #021765		 SUPPL-20 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/06/2013 INTERMEZZO
NDA #022328		 SUPPL-1 ZOLPIDEM TARTRATE PURDUE PHARMA Manufacturing (CMC) Approval
02/06/2013 CETIRIZINE HYDROCHLORIDE ALLERGY
NDA #022429		 SUPPL-9 CETIRIZINE HYDROCHLORIDE BIONPHARMA Labeling Approval
02/06/2013 CETIRIZINE HYDROCHLORIDE HIVES RELIEF
NDA #022429		 SUPPL-9 CETIRIZINE HYDROCHLORIDE BIONPHARMA Labeling Approval
02/06/2013 ZYLET
NDA #050804		 SUPPL-18 LOTEPREDNOL ETABONATE; TOBRAMYCIN BAUSCH AND LOMB Efficacy Approval
02/06/2013 GENGRAF
ANDA #065003		 SUPPL-16 CYCLOSPORINE ABBVIE Labeling Approval
02/06/2013 CYCLOSPORINE
ANDA #065025		 SUPPL-19 CYCLOSPORINE ABBVIE Labeling Approval
02/06/2013 MONTELUKAST SODIUM
ANDA #078605		 SUPPL-3 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
02/06/2013 MONTELUKAST SODIUM
ANDA #078723		 SUPPL-3 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
02/06/2013 POLYETHYLENE GLYCOL 3350
ANDA #090685		 SUPPL-2 POLYETHYLENE GLYCOL 3350 PPI-DAC Labeling Approval
02/06/2013 MONTELUKAST SODIUM
ANDA #090955		 SUPPL-4 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
02/06/2013 LUCENTIS
BLA #125156		 SUPPL-81 RANIBIZUMAB GENENTECH Approval
02/06/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #202467		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE MACLEODS PHARMS LTD Approval
02/06/2013 VERSACLOZ
NDA #203479		 ORIG-1 CLOZAPINE DOUGLAS PHARMS Type 3 - New Dosage Form Approval
02/07/2013 MONISTAT 3
NDA #018888		 SUPPL-14 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/07/2013 SAIZEN
BLA #019764		 SUPPL-60 SOMATROPIN EMD SERONO Approval
02/07/2013 NOVOLIN R
BLA #019938		 SUPPL-72 INSULIN RECOMBINANT HUMAN NOVO NORDISK INC Approval
02/07/2013 ALEVE
NDA #020204		 SUPPL-38 NAPROXEN SODIUM BAYER Labeling Approval
02/07/2013 TAMIFLU
NDA #021246		 SUPPL-46 OSELTAMIVIR PHOSPHATE ROCHE Manufacturing (CMC) Approval
02/07/2013 JANUMET
NDA #022044		 SUPPL-27 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
02/07/2013 SANDIMMUNE
NDA #050573		 SUPPL-38 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
02/07/2013 RANITIDINE HYDROCHLORIDE
ANDA #074467		 SUPPL-36 RANITIDINE HYDROCHLORIDE SANDOZ Labeling Approval
02/07/2013 RANITIDINE HYDROCHLORIDE
ANDA #074655		 SUPPL-35 RANITIDINE HYDROCHLORIDE SANDOZ Labeling Approval
02/07/2013 ETODOLAC
ANDA #075126		 SUPPL-5 ETODOLAC ANI PHARMS Labeling Approval
02/07/2013 ETODOLAC
ANDA #075419		 SUPPL-8 ETODOLAC APOTEX Labeling Approval
02/07/2013 ETODOLAC
ANDA #076004		 SUPPL-8 ETODOLAC APOTEX Labeling Approval
02/07/2013 ISOPTO CARPINE
NDA #200890		 SUPPL-3 PILOCARPINE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
02/07/2013 CALCIUM ACETATE
ANDA #203135		 ORIG-1 CALCIUM ACETATE INVAGEN PHARMS Approval
02/08/2013 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-61 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 CYTOTEC
NDA #019268		 SUPPL-48 MISOPROSTOL PFIZER Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-50 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-50 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-50 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 SAIZEN
BLA #019764		 SUPPL-61 SOMATROPIN EMD SERONO Approval
02/08/2013 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-32 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-32 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
02/08/2013 RISPERDAL
NDA #020272		 SUPPL-71 RISPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
02/08/2013 GONAL-F
BLA #020378		 SUPPL-54 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/08/2013 SEROSTIM
BLA #020604		 SUPPL-65 SOMATROPIN EMD SERONO Approval
02/08/2013 SEROSTIM LQ
BLA #020604		 SUPPL-65 SOMATROPIN EMD SERONO Approval
02/08/2013 ARTHROTEC
NDA #020607		 SUPPL-26 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Manufacturing (CMC) Approval
02/08/2013 DIFFERIN
NDA #020748		 SUPPL-8 ADAPALENE GALDERMA LABS LP Manufacturing (CMC) Approval
02/08/2013 THALOMID
NDA #020785		 SUPPL-48 THALIDOMIDE BRISTOL-MYERS REMS Approval
02/08/2013 FORADIL
NDA #020831		 SUPPL-30 FORMOTEROL FUMARATE NOVARTIS Manufacturing (CMC) Approval
02/08/2013 VIRAMUNE
NDA #020933		 SUPPL-34 NEVIRAPINE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
02/08/2013 TRILEPTAL
NDA #021014		 SUPPL-29 OXCARBAZEPINE NOVARTIS Labeling Approval
02/08/2013 OVIDREL
BLA #021149		 SUPPL-32 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
02/08/2013 TRILEPTAL
NDA #021285		 SUPPL-23 OXCARBAZEPINE NOVARTIS Labeling Approval
02/08/2013 ELIGARD KIT
NDA #021379		 SUPPL-23 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
02/08/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-27 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/08/2013 GONAL-F
BLA #021765		 SUPPL-24 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/08/2013 GONAL-F RFF
BLA #021765		 SUPPL-24 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/08/2013 REVLIMID
NDA #021880		 SUPPL-29 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
02/08/2013 REVLIMID
NDA #021880		 SUPPL-33 LENALIDOMIDE BRISTOL MYERS SQUIBB Labeling Approval
02/08/2013 VIMPAT
NDA #022253		 SUPPL-10 LACOSAMIDE UCB INC Labeling Approval
02/08/2013 VIMPAT
NDA #022254		 SUPPL-5 LACOSAMIDE UCB INC Labeling Approval
02/08/2013 VIMPAT
NDA #022255		 SUPPL-2 LACOSAMIDE UCB INC Labeling Approval
02/08/2013 MYFORTIC
NDA #050791		 SUPPL-15 MYCOPHENOLATE SODIUM NOVARTIS Manufacturing (CMC) Approval
02/08/2013 CARBIDOPA AND LEVODOPA
ANDA #202323		 ORIG-1 CARBIDOPA; LEVODOPA ACCORD HLTHCARE Approval
02/08/2013 POMALYST
NDA #204026		 ORIG-1 POMALIDOMIDE BRISTOL Type 1 - New Molecular Entity Approval
02/11/2013 JANUVIA
NDA #021995		 SUPPL-27 SITAGLIPTIN PHOSPHATE MSD Labeling Approval
02/11/2013 CEFTAZIDIME
ANDA #062640		 SUPPL-34 CEFTAZIDIME ACS DOBFAR Labeling Approval
02/11/2013 NIZATIDINE
ANDA #076178		 SUPPL-7 NIZATIDINE EPIC PHARMA LLC Labeling Approval
02/11/2013 LATANOPROST
ANDA #202077		 ORIG-1 LATANOPROST CARNEGIE Approval
02/11/2013 LATANOPROST
ANDA #202077		 SUPPL-11 LATANOPROST CARNEGIE Approval
02/11/2013 JANUMET XR
NDA #202270		 SUPPL-3 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
02/11/2013 JUVISYNC
NDA #202343		 SUPPL-6 SIMVASTATIN; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
02/12/2013 FML
NDA #016851		 SUPPL-63 FLUOROMETHOLONE ABBVIE Labeling Approval
02/12/2013 FML
NDA #017760		 SUPPL-17 FLUOROMETHOLONE ALLERGAN Labeling Approval
02/12/2013 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-60 HEPARIN SODIUM HOSPIRA Labeling Approval
02/12/2013 FML FORTE
NDA #019216		 SUPPL-25 FLUOROMETHOLONE ABBVIE Labeling Approval
02/12/2013 LEXIVA
NDA #021548		 SUPPL-31 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
02/12/2013 TOTECT
NDA #022025		 SUPPL-14 DEXRAZOXANE HYDROCHLORIDE CLINIGEN Manufacturing (CMC) Approval
02/12/2013 LEXIVA
NDA #022116		 SUPPL-15 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
02/12/2013 JENLOGA
NDA #022331		 SUPPL-12 CLONIDINE HYDROCHLORIDE CONCORDIA PHARMS INC Labeling Approval
02/12/2013 KAPVAY
NDA #022331		 SUPPL-12 CLONIDINE HYDROCHLORIDE CONCORDIA PHARMS INC Labeling Approval
02/12/2013 DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
ANDA #076536		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BARR LABS INC Approval
02/12/2013 ROCURONIUM BROMIDE
ANDA #079195		 SUPPL-6 ROCURONIUM BROMIDE SANDOZ Labeling Approval
02/12/2013 RISPERIDONE
ANDA #091537		 SUPPL-2 RISPERIDONE NATCO PHARMA USA Manufacturing (CMC) Approval
02/12/2013 QUETIAPINE FUMARATE
ANDA #201504		 ORIG-1 QUETIAPINE FUMARATE ALKEM LABS LTD Approval
02/12/2013 MAFENIDE ACETATE
ANDA #201511		 ORIG-1 MAFENIDE ACETATE PH HEALTH Approval
02/13/2013 XYLOCAINE
NDA #006488		 SUPPL-85 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/13/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-85 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/13/2013 CALAN
NDA #018817		 SUPPL-29 VERAPAMIL HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
02/13/2013 DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-33 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Labeling Approval
02/13/2013 DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-33 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Labeling Approval
02/13/2013 DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-33 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Labeling Approval
02/13/2013 SAIZEN
BLA #019764		 SUPPL-63 SOMATROPIN EMD SERONO Approval
02/13/2013 CLARITIN-D 24 HOUR
NDA #020470		 SUPPL-40 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/13/2013 ORFADIN
NDA #021232		 SUPPL-10 NITISINONE SWEDISH ORPHAN Labeling Approval
02/13/2013 GRALISE
NDA #022544		 SUPPL-15 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
02/13/2013 GLYCOPYRROLATE
ANDA #040844		 SUPPL-2 GLYCOPYRROLATE SUN PHARM INDS LTD Labeling Approval
02/13/2013 CEFAZOLIN SODIUM
ANDA #065306		 SUPPL-4 CEFAZOLIN SODIUM ACS DOBFAR Labeling Approval
02/13/2013 FELODIPINE
ANDA #075896		 SUPPL-13 FELODIPINE SUN PHARM INDUSTRIES Labeling Approval
02/13/2013 FELODIPINE
ANDA #075896		 SUPPL-14 FELODIPINE SUN PHARM INDUSTRIES Labeling Approval
02/13/2013 ANAGRELIDE HYDROCHLORIDE
ANDA #076811		 SUPPL-7 ANAGRELIDE HYDROCHLORIDE NOVITIUM PHARMA Labeling Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #078472		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE PHARMOBEDIENT Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #078670		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE AIPING PHARM INC Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #091298		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE TORRENT PHARMS LTD Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #200044		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE ACCORD HLTHCARE Approval
02/13/2013 OXYTOCIN
ANDA #200219		 ORIG-1 OXYTOCIN HIKMA FARMACEUTICA Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #200268		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
02/13/2013 SIGNIFOR
NDA #200677		 SUPPL-1 PASIREOTIDE DIASPARTATE RECORDATI RARE Labeling Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #200823		 ORIG-1 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #202001		 ORIG-1 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TORRENT PHARMS LTD Approval
02/13/2013 VICTRELIS
NDA #202258		 SUPPL-3 BOCEPREVIR MERCK SHARP DOHME Efficacy Approval
02/13/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #202456		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE ZYDUS PHARMS USA INC Approval
02/13/2013 ARGATROBAN
NDA #203049		 SUPPL-2 ARGATROBAN HIKMA PHARM CO LTD Manufacturing (CMC) Approval
02/14/2013 EMCYT
NDA #018045		 SUPPL-28 ESTRAMUSTINE PHOSPHATE SODIUM PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
02/14/2013 GONAL-F
BLA #020378		 SUPPL-55 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/14/2013 RYTHMOL SR
NDA #021416		 SUPPL-11 PROPAFENONE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
02/14/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-28 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/14/2013 GONAL-F
BLA #021765		 SUPPL-25 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/14/2013 GONAL-F RFF
BLA #021765		 SUPPL-25 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/14/2013 PRISTIQ
NDA #021992		 SUPPL-33 DESVENLAFAXINE SUCCINATE PF PRISM CV Efficacy Approval
02/14/2013 PRISTIQ
NDA #021992		 SUPPL-36 DESVENLAFAXINE SUCCINATE PF PRISM CV Labeling Approval
02/14/2013 SELZENTRY
NDA #022128		 SUPPL-11 MARAVIROC VIIV HLTHCARE Labeling Approval
02/14/2013 SANCUSO
NDA #022198		 SUPPL-9 GRANISETRON CUMBERLAND Manufacturing (CMC) Approval
02/14/2013 CELLCEPT
NDA #050722		 SUPPL-27 MYCOPHENOLATE MOFETIL ROCHE PALO Manufacturing (CMC) Approval
02/14/2013 CELLCEPT
NDA #050723		 SUPPL-26 MYCOPHENOLATE MOFETIL ROCHE PALO Manufacturing (CMC) Approval
02/14/2013 CELLCEPT
NDA #050758		 SUPPL-25 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Manufacturing (CMC) Approval
02/14/2013 CELLCEPT
NDA #050759		 SUPPL-32 MYCOPHENOLATE MOFETIL ROCHE PALO Manufacturing (CMC) Approval
02/14/2013 FENTANYL-100
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 FENTANYL-12
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 FENTANYL-25
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 FENTANYL-37
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 FENTANYL-50
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 FENTANYL-62
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 FENTANYL-75
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 FENTANYL-87
ANDA #077449		 SUPPL-3 FENTANYL DIFGEN PHARMS REMS Approval
02/14/2013 GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078096		 SUPPL-2 GRANISETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/14/2013 GRANISETRON HYDROCHLORIDE
ANDA #078522		 SUPPL-2 GRANISETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/14/2013 ARIPIPRAZOLE
ANDA #078614		 ORIG-1 ARIPIPRAZOLE SUN PHARMA GLOBAL Tentative Approval
02/14/2013 URSODIOL
ANDA #202540		 ORIG-1 URSODIOL PH HEALTH Approval
02/14/2013 FLUDEOXYGLUCOSE F18
ANDA #203665		 ORIG-1 FLUDEOXYGLUCOSE F-18 SOFIE Approval
02/15/2013 HUMULIN N
BLA #018781		 SUPPL-128 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/15/2013 HUMULIN 70/30
BLA #019717		 SUPPL-107 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/15/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-107 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/15/2013 SAIZEN
BLA #019764		 SUPPL-65 SOMATROPIN EMD SERONO Approval
02/15/2013 SAIZEN
BLA #019764		 SUPPL-66 SOMATROPIN EMD SERONO Approval
02/15/2013 GONAL-F
BLA #020378		 SUPPL-53 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/15/2013 HUMALOG
BLA #020563		 SUPPL-132 INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-132 INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG PEN
BLA #020563		 SUPPL-132 INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-132 INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 SEROSTIM
BLA #020604		 SUPPL-68 SOMATROPIN EMD SERONO Approval
02/15/2013 SEROSTIM LQ
BLA #020604		 SUPPL-68 SOMATROPIN EMD SERONO Approval
02/15/2013 AROMASIN
NDA #020753		 SUPPL-14 EXEMESTANE PFIZER Labeling Approval
02/15/2013 ANGIOMAX
NDA #020873		 SUPPL-28 BIVALIRUDIN SANDOZ Manufacturing (CMC) Approval
02/15/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-87 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-87 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-87 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG MIX 50/50
BLA #021018		 SUPPL-81 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-81 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-81 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/15/2013 RELENZA
NDA #021036		 SUPPL-28 ZANAMIVIR GLAXOSMITHKLINE Manufacturing (CMC) Approval
02/15/2013 AVAGARD
NDA #021074		 SUPPL-9 ALCOHOL; CHLORHEXIDINE GLUCONATE SOLVENTUM Labeling Approval
02/15/2013 ALAMAST
NDA #021079		 SUPPL-14 PEMIROLAST POTASSIUM SANTEN Manufacturing (CMC) Approval
02/15/2013 FORTEO
NDA #021318		 SUPPL-32 TERIPARATIDE LILLY Manufacturing (CMC) Approval
02/15/2013 ZETIA
NDA #021445		 SUPPL-35 EZETIMIBE ORGANON Manufacturing (CMC) Approval
02/15/2013 LEVEMIR
BLA #021536		 SUPPL-45 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/15/2013 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-45 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/15/2013 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-45 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/15/2013 LEVEMIR INNOLET
BLA #021536		 SUPPL-45 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/15/2013 LEVEMIR PENFILL
BLA #021536		 SUPPL-45 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/15/2013 ZORTRESS
NDA #021560		 SUPPL-6 EVEROLIMUS NOVARTIS Efficacy Approval
02/15/2013 APIDRA
BLA #021629		 SUPPL-27 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
02/15/2013 APIDRA SOLOSTAR
BLA #021629		 SUPPL-27 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
02/15/2013 EPIDUO
NDA #022320		 SUPPL-5 ADAPALENE; BENZOYL PEROXIDE GALDERMA LABS LP Manufacturing (CMC) Approval
02/15/2013 WELCHOL
NDA #022362		 SUPPL-13 COLESEVELAM HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
02/15/2013 GRANISETRON HYDROCHLORIDE
ANDA #078090		 SUPPL-2 GRANISETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/15/2013 PROLIA
BLA #125320		 SUPPL-80 DENOSUMAB AMGEN Approval
02/15/2013 XGEVA
BLA #125320		 SUPPL-80 DENOSUMAB AMGEN Approval
02/15/2013 VICTRELIS
NDA #202258		 SUPPL-7 BOCEPREVIR MERCK SHARP DOHME Labeling Approval
02/15/2013 STRIBILD
NDA #203100		 SUPPL-1 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
02/16/2013 XYLOCAINE
NDA #006488		 SUPPL-83 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-83 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 NESACAINE
NDA #009435		 SUPPL-40 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 NESACAINE-MPF
NDA #009435		 SUPPL-40 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 CHORIONIC GONADOTROPIN
BLA #017067		 SUPPL-59 GONADOTROPIN, CHORIONIC FRESENIUS KABI USA Approval
02/16/2013 HEPARIN SODIUM
NDA #017651		 SUPPL-56 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 PENTAM
NDA #019264		 SUPPL-31 PENTAMIDINE ISETHIONATE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 NEBUPENT
NDA #019887		 SUPPL-16 PENTAMIDINE ISETHIONATE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 NAROPIN
NDA #020533		 SUPPL-30 ROPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 TOBRAMYCIN SULFATE
NDA #050789		 SUPPL-8 TOBRAMYCIN SULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/16/2013 LEVOTHYROXINE SODIUM
NDA #202231		 SUPPL-4 LEVOTHYROXINE SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
02/19/2013 MIACALCIN
NDA #017808		 SUPPL-33 CALCITONIN SALMON MYLAN IRELAND LTD Manufacturing (CMC) Approval
02/19/2013 GONAL-F
BLA #020378		 SUPPL-56 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/19/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-29 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/19/2013 GONAL-F
BLA #021765		 SUPPL-26 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/19/2013 GONAL-F RFF
BLA #021765		 SUPPL-26 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/19/2013 CHANTIX
NDA #021928		 SUPPL-30 VARENICLINE TARTRATE PF PRISM CV Efficacy Approval
02/19/2013 ZITHROMAX
NDA #050693		 SUPPL-23 AZITHROMYCIN PFIZER Labeling Approval
02/19/2013 ZITHROMAX
NDA #050710		 SUPPL-39 AZITHROMYCIN PFIZER Labeling Approval
02/19/2013 ZITHROMAX
NDA #050711		 SUPPL-36 AZITHROMYCIN PFIZER Labeling Approval
02/19/2013 ZITHROMAX
NDA #050730		 SUPPL-31 AZITHROMYCIN PFIZER Labeling Approval
02/19/2013 ZITHROMAX
NDA #050733		 SUPPL-35 AZITHROMYCIN PFIZER Labeling Approval
02/19/2013 ELLENCE
NDA #050778		 SUPPL-19 EPIRUBICIN HYDROCHLORIDE PFIZER INC Labeling Approval
02/19/2013 ZITHROMAX
NDA #050784		 SUPPL-23 AZITHROMYCIN PFIZER Labeling Approval
02/19/2013 ZMAX
NDA #050797		 SUPPL-17 AZITHROMYCIN PF PRISM CV Labeling Approval
02/19/2013 METOPROLOL TARTRATE
ANDA #073288		 SUPPL-35 METOPROLOL TARTRATE CHARTWELL RX Labeling Approval
02/19/2013 METOPROLOL TARTRATE
ANDA #073289		 SUPPL-31 METOPROLOL TARTRATE CHARTWELL RX Labeling Approval
02/19/2013 METOPROLOL TARTRATE
ANDA #074644		 SUPPL-31 METOPROLOL TARTRATE SUN PHARM INDS INC Labeling Approval
02/19/2013 CLOMIPHENE CITRATE
ANDA #075528		 SUPPL-8 CLOMIPHENE CITRATE COSETTE Labeling Approval
02/19/2013 LISINOPRIL
ANDA #075994		 SUPPL-27 LISINOPRIL CHARTWELL RX Labeling Approval
02/19/2013 LISINOPRIL
ANDA #075994		 SUPPL-29 LISINOPRIL CHARTWELL RX Labeling Approval
02/19/2013 LISINOPRIL
ANDA #075994		 SUPPL-31 LISINOPRIL CHARTWELL RX Labeling Approval
02/19/2013 METOPROLOL TARTRATE
ANDA #076670		 SUPPL-11 METOPROLOL TARTRATE SUN PHARM INDS INC Labeling Approval
02/19/2013 TERBINAFINE HYDROCHLORIDE
ANDA #078199		 SUPPL-5 TERBINAFINE HYDROCHLORIDE CHARTWELL Labeling Approval
02/19/2013 LEVALBUTEROL HYDROCHLORIDE
ANDA #078309		 SUPPL-8 LEVALBUTEROL HYDROCHLORIDE MYLAN SPECIALITY LP Labeling Approval
02/19/2013 TOPIRAMATE
ANDA #090162		 SUPPL-2 TOPIRAMATE UNICHEM LABS LTD Manufacturing (CMC) Approval
02/19/2013 LORAZEPAM
ANDA #091407		 ORIG-1 LORAZEPAM LUPIN LTD Approval
02/19/2013 MONTELUKAST SODIUM
ANDA #201582		 SUPPL-3 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
02/19/2013 AMYVID
NDA #202008		 SUPPL-7 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
02/19/2013 AMYVID
NDA #202008		 SUPPL-10 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
02/19/2013 AMYVID
NDA #202008		 SUPPL-11 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
02/20/2013 XYLOCAINE
NDA #006488		 SUPPL-86 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/20/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-86 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/20/2013 SAIZEN
BLA #019764		 SUPPL-67 SOMATROPIN EMD SERONO Approval
02/20/2013 GONAL-F
BLA #020378		 SUPPL-57 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/20/2013 DURAPREP
NDA #021586		 SUPPL-3 IODINE POVACRYLEX; ISOPROPYL ALCOHOL SOLVENTUM Manufacturing (CMC) Approval
02/20/2013 INTUNIV
NDA #022037		 SUPPL-8 GUANFACINE HYDROCHLORIDE TAKEDA PHARMS USA Efficacy Approval
02/20/2013 AMIKACIN SULFATE
ANDA #064045		 SUPPL-24 AMIKACIN SULFATE MEITHEAL Labeling Approval
02/20/2013 LISINOPRIL
ANDA #075999		 SUPPL-9 LISINOPRIL RISING Labeling Approval
02/20/2013 LISINOPRIL
ANDA #076059		 SUPPL-43 LISINOPRIL WATSON LABS Labeling Approval
02/20/2013 LISINOPRIL
ANDA #076059		 SUPPL-44 LISINOPRIL WATSON LABS Labeling Approval
02/20/2013 ITRACONAZOLE
ANDA #076104		 SUPPL-11 ITRACONAZOLE SANDOZ Labeling Approval
02/20/2013 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #076899		 SUPPL-12 SULFAMETHOXAZOLE; TRIMETHOPRIM AMNEAL PHARMS NY Labeling Approval
02/20/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078385		 SUPPL-9 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
02/20/2013 EPLERENONE
ANDA #078510		 SUPPL-4 EPLERENONE SANDOZ Labeling Approval
02/20/2013 EPLERENONE
ANDA #078510		 SUPPL-6 EPLERENONE SANDOZ Labeling Approval
02/20/2013 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #090037		 SUPPL-6 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE BAUSCH AND LOMB Labeling Approval
02/20/2013 DORZOLAMIDE HYDROCHLORIDE
ANDA #090143		 SUPPL-5 DORZOLAMIDE HYDROCHLORIDE BAUSCH AND LOMB Labeling Approval
02/20/2013 SUPRAX
NDA #202091		 ORIG-1 CEFIXIME LUPIN LTD Type 5 - New Formulation or New Manufacturer Approval
02/20/2013 VITUZ
NDA #204307		 ORIG-1 CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE PERSION Type 3 - New Dosage Form Approval
02/21/2013 FORANE
NDA #017624		 SUPPL-39 ISOFLURANE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/21/2013 HUMULIN N
BLA #018781		 SUPPL-131 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/21/2013 IMODIUM A-D
NDA #019860		 SUPPL-31 LOPERAMIDE HYDROCHLORIDE KENVUE BRANDS Manufacturing (CMC) Approval
02/21/2013 NIASPAN
NDA #020381		 SUPPL-48 NIACIN ABBVIE Labeling Approval
02/21/2013 NIASPAN TITRATION STARTER PACK
NDA #020381		 SUPPL-48 NIACIN ABBVIE Labeling Approval
02/21/2013 ATACAND
NDA #020838		 SUPPL-37 CANDESARTAN CILEXETIL ANI PHARMS Manufacturing (CMC) Approval
02/21/2013 PHOSLO
NDA #021160		 SUPPL-25 CALCIUM ACETATE FRESENIUS MEDCL CARE Manufacturing (CMC) Approval
02/21/2013 PHOSLO GELCAPS
NDA #021160		 SUPPL-25 CALCIUM ACETATE FRESENIUS MEDCL CARE Manufacturing (CMC) Approval
02/21/2013 GLEEVEC
NDA #021588		 SUPPL-38 IMATINIB MESYLATE NOVARTIS Labeling Approval
02/21/2013 FENTORA
NDA #021947		 SUPPL-8 FENTANYL CITRATE CEPHALON Efficacy Approval
02/21/2013 AMOXICILLIN
ANDA #065256		 SUPPL-7 AMOXICILLIN AUROBINDO Labeling Approval
02/21/2013 AMOXICILLIN
ANDA #065271		 SUPPL-9 AMOXICILLIN AUROBINDO Labeling Approval
02/21/2013 AMPICILLIN AND SULBACTAM
ANDA #065403		 SUPPL-2 AMPICILLIN SODIUM; SULBACTAM SODIUM ACS DOBFAR Labeling Approval
02/21/2013 AMPICILLIN AND SULBACTAM
ANDA #065403		 SUPPL-6 AMPICILLIN SODIUM; SULBACTAM SODIUM ACS DOBFAR Labeling Approval
02/21/2013 AMPICILLIN AND SULBACTAM
ANDA #065406		 SUPPL-7 AMPICILLIN SODIUM; SULBACTAM SODIUM ACS DOBFAR Labeling Approval
02/21/2013 TRI-SPRINTEC
ANDA #075808		 SUPPL-29 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
02/21/2013 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-3 BUPRENORPHINE HYDROCHLORIDE HIKMA Labeling Approval
02/21/2013 DIFICID
NDA #201699		 SUPPL-5 FIDAXOMICIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
02/21/2013 KYPROLIS
NDA #202714		 SUPPL-1 CARFILZOMIB ONYX PHARMS AMGEN Manufacturing (CMC) Approval
02/22/2013 MYAMBUTOL
NDA #016320		 SUPPL-66 ETHAMBUTOL HYDROCHLORIDE KANCHAN HLTHCARE Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-47 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-47 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-47 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-47 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-47 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-47 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 CARNITOR
NDA #018948		 SUPPL-25 LEVOCARNITINE LEADIANT BIOSCI INC Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/2013 COPAXONE
NDA #020622		 SUPPL-79 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
02/22/2013 QUALAQUIN
NDA #021799		 SUPPL-21 QUININE SULFATE SUN PHARM INDUSTRIES Labeling Approval
02/22/2013 PREZISTA
NDA #021976		 SUPPL-30 DARUNAVIR JANSSEN PRODS Labeling Approval
02/22/2013 AMOXICILLIN
ANDA #064076		 SUPPL-25 AMOXICILLIN SANDOZ Labeling Approval
02/22/2013 AMOXICILLIN
ANDA #065228		 SUPPL-6 AMOXICILLIN SANDOZ Labeling Approval
02/22/2013 AMPICILLIN AND SULBACTAM
ANDA #065241		 SUPPL-11 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
02/22/2013 AMOXICILLIN
ANDA #065378		 SUPPL-8 AMOXICILLIN SANDOZ Labeling Approval
02/22/2013 AMOXICILLIN
ANDA #065387		 SUPPL-8 AMOXICILLIN SANDOZ Labeling Approval
02/22/2013 NICOTINE POLACRILEX
ANDA #074707		 SUPPL-48 NICOTINE POLACRILEX P AND L Labeling Approval
02/22/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078287		 ORIG-1 ONDANSETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Approval
02/22/2013 ONDANSETRON HYDROCHLORIDE
ANDA #078288		 ORIG-1 ONDANSETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Approval
02/22/2013 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE HIKMA Labeling Approval
02/22/2013 FAMOTIDINE
ANDA #078916		 SUPPL-2 FAMOTIDINE ALEMBIC PHARMS LTD Labeling Approval
02/22/2013 FINASTERIDE
ANDA #090061		 SUPPL-5 FINASTERIDE HETERO LABS LTD III Labeling Approval
02/22/2013 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE BARR Labeling Approval
02/22/2013 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622		 SUPPL-5 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM Labeling Approval
02/22/2013 VALPROIC ACID
ANDA #091037		 ORIG-1 VALPROIC ACID SUN PHARM INDS LTD Approval
02/22/2013 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
02/22/2013 RANITIDINE HYDROCHLORIDE
ANDA #091534		 ORIG-1 RANITIDINE HYDROCHLORIDE ZYDUS PHARMS USA INC Approval
02/22/2013 KADCYLA
BLA #125427		 ORIG-1 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
02/22/2013 POTASSIUM CHLORIDE
ANDA #202128		 ORIG-1 POTASSIUM CHLORIDE AMNEAL PHARMS Approval
02/22/2013 LEVONORGESTREL
ANDA #202508		 ORIG-1 LEVONORGESTREL NOVEL LABS INC Approval
02/22/2013 ZIOPTAN
NDA #202514		 SUPPL-1 TAFLUPROST THEA PHARMA Labeling Approval
02/22/2013 PREZISTA
NDA #202895		 SUPPL-7 DARUNAVIR JANSSEN PRODS Labeling Approval
02/22/2013 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Approval
02/22/2013 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203630		 ORIG-1 HYDROCHLOROTHIAZIDE; IRBESARTAN AUROBINDO PHARMA LTD Approval
02/25/2013 PROVENTIL-HFA
NDA #020503		 SUPPL-47 ALBUTEROL SULFATE KINDEVA Manufacturing (CMC) Approval
02/25/2013 WELCHOL
NDA #021176		 SUPPL-36 COLESEVELAM HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
02/25/2013 ARCAPTA NEOHALER
NDA #022383		 SUPPL-3 INDACATEROL MALEATE NOVARTIS Manufacturing (CMC) Approval
02/25/2013 ALENDRONATE SODIUM
ANDA #090520		 ORIG-1 ALENDRONATE SODIUM HIKMA Approval
02/25/2013 CAFFEINE CITRATE
ANDA #090827		 SUPPL-2 CAFFEINE CITRATE SAGENT PHARMS Labeling Approval
02/25/2013 SILDENAFIL CITRATE
ANDA #200149		 ORIG-1 SILDENAFIL CITRATE ACTAVIS GRP PTC Approval
02/25/2013 SILDENAFIL CITRATE
ANDA #200165		 ORIG-1 SILDENAFIL CITRATE ACTAVIS PHARMA Tentative Approval
02/25/2013 DONEPEZIL HYDROCHLORIDE
ANDA #201724		 ORIG-1 DONEPEZIL HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
02/25/2013 AMMONIA N 13
ANDA #203321		 ORIG-1 AMMONIA N-13 MCPRF Approval
02/25/2013 AMMONIA N 13
ANDA #203700		 ORIG-1 AMMONIA N-13 CARDINAL HLTH 414 Approval
02/25/2013 STIVARGA
NDA #204369		 ORIG-1 REGORAFENIB BAYER HEALTHCARE PHARMS Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
02/26/2013 PREGNYL
BLA #017692		 SUPPL-23 GONADOTROPIN, CHORIONIC ORGANON USA LLC Approval
02/26/2013 PRINIVIL
NDA #019558		 SUPPL-56 LISINOPRIL MERCK Labeling Approval
02/26/2013 PRINZIDE
NDA #019778		 SUPPL-49 HYDROCHLOROTHIAZIDE; LISINOPRIL MERCK Labeling Approval
02/26/2013 VUMON
NDA #020119		 SUPPL-12 TENIPOSIDE HQ SPECLT PHARMA Manufacturing (CMC) Approval
02/26/2013 ACEON
NDA #020184		 SUPPL-20 PERINDOPRIL ERBUMINE SYMPLMED PHARMS LLC Labeling Approval
02/26/2013 GONAL-F
BLA #020378		 SUPPL-59 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/26/2013 RISPERDAL CONSTA
NDA #021346		 SUPPL-48 RISPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
02/26/2013 BROVANA
NDA #021912		 SUPPL-22 ARFORMOTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
02/26/2013 STAVZOR
NDA #022152		 SUPPL-3 VALPROIC ACID BIONPHARMA Labeling Approval
02/26/2013 STAVZOR
NDA #022152		 SUPPL-4 VALPROIC ACID BIONPHARMA Labeling Approval
02/26/2013 MOZOBIL
NDA #022311		 SUPPL-12 PLERIXAFOR GENZYME Manufacturing (CMC) Approval
02/26/2013 POTASSIUM CHLORIDE
ANDA #077419		 SUPPL-15 POTASSIUM CHLORIDE ACTAVIS LABS FL INC Labeling Approval
02/26/2013 FINASTERIDE
ANDA #078341		 SUPPL-10 FINASTERIDE AUROBINDO PHARMA Labeling Approval
02/26/2013 OSPHENA
NDA #203505		 ORIG-1 OSPEMIFENE DUCHESNAY Type 1 - New Molecular Entity Approval
02/27/2013 DEPAKENE
NDA #018081		 SUPPL-54 VALPROIC ACID ABBVIE Labeling Approval
02/27/2013 DEPAKENE
NDA #018082		 SUPPL-38 VALPROIC ACID ABBVIE Labeling Approval
02/27/2013 DEPAKOTE
NDA #018723		 SUPPL-47 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/27/2013 DEPAKOTE
NDA #019680		 SUPPL-34 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/27/2013 DEPACON
NDA #020593		 SUPPL-25 VALPROATE SODIUM ABBVIE Labeling Approval
02/27/2013 URSO 250
NDA #020675		 SUPPL-21 URSODIOL ABBVIE Manufacturing (CMC) Approval
02/27/2013 URSO FORTE
NDA #020675		 SUPPL-21 URSODIOL ABBVIE Manufacturing (CMC) Approval
02/27/2013 PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
NDA #020849		 SUPPL-15 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
02/27/2013 MALARONE
NDA #021078		 SUPPL-22 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
02/27/2013 MALARONE PEDIATRIC
NDA #021078		 SUPPL-22 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
02/27/2013 DEPAKOTE ER
NDA #021168		 SUPPL-23 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/27/2013 ELIGARD KIT
NDA #021343		 SUPPL-27 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/27/2013 ELIGARD KIT
NDA #021379		 SUPPL-25 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/27/2013 ELIGARD KIT
NDA #021488		 SUPPL-25 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/27/2013 ELIGARD KIT
NDA #021731		 SUPPL-23 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/27/2013 XOLEGEL
NDA #021946		 SUPPL-6 KETOCONAZOLE INA PHARMS Manufacturing (CMC) Approval
02/27/2013 INTELENCE
NDA #022187		 SUPPL-11 ETRAVIRINE JANSSEN R AND D Labeling Approval
02/27/2013 INTELENCE
NDA #022187		 SUPPL-12 ETRAVIRINE JANSSEN R AND D Labeling Approval
02/27/2013 INTELENCE
NDA #022187		 SUPPL-14 ETRAVIRINE JANSSEN R AND D Labeling Approval
02/27/2013 BYDUREON
NDA #022200		 SUPPL-5 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
02/27/2013 BYDUREON PEN
NDA #022200		 SUPPL-5 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
02/27/2013 WELCHOL
NDA #022362		 SUPPL-14 COLESEVELAM HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
02/27/2013 RIFADIN
NDA #050420		 SUPPL-75 RIFAMPIN SANOFI AVENTIS US Labeling Approval
02/27/2013 RIFADIN
NDA #050627		 SUPPL-14 RIFAMPIN SANOFI AVENTIS US Labeling Approval
02/27/2013 RIFATER
NDA #050705		 SUPPL-10 ISONIAZID; PYRAZINAMIDE; RIFAMPIN SANOFI AVENTIS US Labeling Approval
02/27/2013 NORTREL 1/35-21
ANDA #072693		 SUPPL-24 ETHINYL ESTRADIOL; NORETHINDRONE BARR Labeling Approval
02/27/2013 NORTREL 0.5/35-28
ANDA #072695		 SUPPL-22 ETHINYL ESTRADIOL; NORETHINDRONE BARR LABS Labeling Approval
02/27/2013 NORTREL 1/35-28
ANDA #072696		 SUPPL-23 ETHINYL ESTRADIOL; NORETHINDRONE BARR LABS Labeling Approval
02/27/2013 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #073303		 SUPPL-28 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA PHARMS USA Labeling Approval
02/27/2013 METOPROLOL TARTRATE
ANDA #074133		 SUPPL-21 METOPROLOL TARTRATE HOSPIRA Labeling Approval
02/27/2013 HYDROXYUREA
ANDA #075143		 SUPPL-16 HYDROXYUREA BARR Labeling Approval
02/27/2013 HYDROXYUREA
ANDA #075143		 SUPPL-17 HYDROXYUREA BARR Labeling Approval
02/27/2013 METOPROLOL TARTRATE
ANDA #075160		 SUPPL-14 METOPROLOL TARTRATE HOSPIRA Labeling Approval
02/27/2013 HYDROXYUREA
ANDA #075340		 SUPPL-9 HYDROXYUREA PH HEALTH Labeling Approval
02/27/2013 EMOQUETTE
ANDA #076675		 SUPPL-3 DESOGESTREL; ETHINYL ESTRADIOL PH HEALTH Labeling Approval
02/27/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077545		 SUPPL-3 ONDANSETRON HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
02/27/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077545		 SUPPL-4 ONDANSETRON HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
02/27/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077545		 SUPPL-7 ONDANSETRON HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
02/27/2013 METOPROLOL TARTRATE
ANDA #077761		 SUPPL-13 METOPROLOL TARTRATE HIKMA FARMACEUTICA Labeling Approval
02/27/2013 METOPROLOL TARTRATE
ANDA #078085		 SUPPL-6 METOPROLOL TARTRATE HOSPIRA Labeling Approval
02/27/2013 LEVETIRACETAM
ANDA #078582		 SUPPL-6 LEVETIRACETAM STRIDES PHARMA Labeling Approval
02/27/2013 TOPIRAMATE
ANDA #078637		 ORIG-1 TOPIRAMATE ACTAVIS TOTOWA Approval
02/27/2013 DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE
ANDA #078648		 ORIG-1 DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE AVANTHI INC Approval
02/27/2013 OXALIPLATIN
ANDA #078817		 SUPPL-1 OXALIPLATIN SANDOZ Labeling Approval
02/27/2013 LEVETIRACETAM
ANDA #079063		 SUPPL-6 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
02/27/2013 LEVETIRACETAM
ANDA #090079		 SUPPL-4 LEVETIRACETAM QUAGEN Labeling Approval
02/27/2013 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #091674		 SUPPL-1 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Labeling Approval
02/27/2013 LATANOPROST
ANDA #201006		 SUPPL-4 LATANOPROST BAUSCH AND LOMB Labeling Approval
02/27/2013 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201524		 ORIG-1 HYDROCHLOROTHIAZIDE; IRBESARTAN CHARTWELL RX Approval
02/27/2013 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201524		 ORIG-2 HYDROCHLOROTHIAZIDE; IRBESARTAN CHARTWELL RX Tentative Approval
02/27/2013 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #201524		 ORIG-1 IRBESARTAN; HYDROCHLOROTHIAZIDE CHARTWELL RX Approval
02/27/2013 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #201524		 ORIG-2 IRBESARTAN; HYDROCHLOROTHIAZIDE CHARTWELL RX Tentative Approval
02/27/2013 QUETIAPINE FUMARATE
ANDA #201762		 ORIG-1 QUETIAPINE FUMARATE ACTAVIS GRP PTC Approval
02/27/2013 VICTRELIS
NDA #202258		 SUPPL-4 BOCEPREVIR MERCK SHARP DOHME Efficacy Approval
02/28/2013 HEXALEN
NDA #019926		 SUPPL-23 ALTRETAMINE EISAI INC Manufacturing (CMC) Approval
02/28/2013 SEROSTIM
BLA #020604		 SUPPL-71 SOMATROPIN EMD SERONO Approval
02/28/2013 SEROSTIM LQ
BLA #020604		 SUPPL-71 SOMATROPIN EMD SERONO Approval
02/28/2013 CLARITIN
NDA #020641		 SUPPL-32 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/28/2013 CLARITIN HIVES RELIEF
NDA #020641		 SUPPL-32 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/28/2013 CREON
BLA #020725		 SUPPL-17 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) ABBVIE Approval
02/28/2013 AVAPRO
NDA #020757		 SUPPL-61 IRBESARTAN SANOFI AVENTIS US Manufacturing (CMC) Approval
02/28/2013 LUMIGAN
NDA #021275		 SUPPL-24 BIMATOPROST ABBVIE Manufacturing (CMC) Approval
02/28/2013 DESMOPRESSIN ACETATE
NDA #021795		 SUPPL-3 DESMOPRESSIN ACETATE FERRING Manufacturing (CMC) Approval
02/28/2013 NEOPROFEN
NDA #021903		 SUPPL-7 IBUPROFEN LYSINE RECORDATI RARE Manufacturing (CMC) Approval
02/28/2013 LYRICA
NDA #022488		 SUPPL-7 PREGABALIN UPJOHN Efficacy Approval
02/28/2013 AZITHROMYCIN
ANDA #065150		 SUPPL-10 AZITHROMYCIN TEVA Labeling Approval
02/28/2013 AZITHROMYCIN
ANDA #065153		 SUPPL-13 AZITHROMYCIN TEVA Labeling Approval
02/28/2013 AZITHROMYCIN
ANDA #065193		 SUPPL-13 AZITHROMYCIN TEVA Labeling Approval
02/28/2013 AZITHROMYCIN
ANDA #065225		 SUPPL-19 AZITHROMYCIN PLIVA Labeling Approval
02/28/2013 AZITHROMYCIN
ANDA #065246		 SUPPL-15 AZITHROMYCIN PLIVA Labeling Approval
02/28/2013 AZITHROMYCIN
ANDA #065419		 SUPPL-9 AZITHROMYCIN TEVA PHARMS Labeling Approval
02/28/2013 KARIVA
ANDA #075863		 SUPPL-20 DESOGESTREL; ETHINYL ESTRADIOL BARR Labeling Approval
02/28/2013 KARIVA
ANDA #075863		 SUPPL-21 DESOGESTREL; ETHINYL ESTRADIOL BARR Labeling Approval
02/28/2013 LISINOPRIL
ANDA #076063		 SUPPL-42 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
02/28/2013 LISINOPRIL
ANDA #076063		 SUPPL-45 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
02/28/2013 LISINOPRIL
ANDA #076063		 SUPPL-47 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
02/28/2013 SIMVASTATIN
ANDA #077837		 SUPPL-27 SIMVASTATIN ZYDUS PHARMS USA Labeling Approval
02/28/2013 LEVETIRACETAM
ANDA #078042		 SUPPL-9 LEVETIRACETAM STRIDES PHARMA Labeling Approval
02/28/2013 OXALIPLATIN
ANDA #078812		 SUPPL-2 OXALIPLATIN SANDOZ Labeling Approval
02/28/2013 LEVETIRACETAM
ANDA #078993		 SUPPL-6 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
02/28/2013 ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
ANDA #079138		 SUPPL-1 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
02/28/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #087602		 SUPPL-29 HYDROXYZINE HYDROCHLORIDE STRIDES PHARMA INTL Labeling Approval
02/28/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #087603		 SUPPL-27 HYDROXYZINE HYDROCHLORIDE STRIDES PHARMA INTL Labeling Approval
02/28/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #087604		 SUPPL-27 HYDROXYZINE HYDROCHLORIDE STRIDES PHARMA INTL Labeling Approval
02/28/2013 LEVETIRACETAM
ANDA #091491		 SUPPL-6 LEVETIRACETAM ZHEJIANG JINGXIN Labeling Approval
02/28/2013 SILDENAFIL CITRATE
ANDA #202025		 ORIG-1 SILDENAFIL CITRATE AMNEAL PHARMS Approval
02/28/2013 XALKORI
NDA #202570		 SUPPL-4 CRIZOTINIB PF PRISM CV Labeling Approval
02/28/2013 ABILIFY MAINTENA KIT
NDA #202971		 ORIG-1 ARIPIPRAZOLE OTSUKA PHARM CO LTD Type 3 - New Dosage Form Approval
02/28/2013 LEVETIRACETAM
ANDA #203052		 ORIG-1 LEVETIRACETAM HETERO LABS LTD III Approval
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