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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 2013

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

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

This report was produced on July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/01/2013 ORAP
NDA #017473		 SUPPL-47 PIMOZIDE TEVA Manufacturing (CMC) Approval
08/01/2013 K-TAB
NDA #018279		 SUPPL-31 POTASSIUM CHLORIDE ABBVIE Manufacturing (CMC) Approval
08/01/2013 GALZIN
NDA #020458		 SUPPL-5 ZINC ACETATE ETON Manufacturing (CMC) Approval
08/01/2013 AMARYL
NDA #020496		 SUPPL-26 GLIMEPIRIDE SANOFI AVENTIS US Labeling Approval
08/01/2013 DITROPAN XL
NDA #020897		 SUPPL-32 OXYBUTYNIN CHLORIDE JANSSEN PHARMS Labeling Approval
08/01/2013 ALTABAX
NDA #022055		 SUPPL-3 RETAPAMULIN ALMIRALL Manufacturing (CMC) Approval
08/01/2013 LISINOPRIL
ANDA #075752		 SUPPL-28 LISINOPRIL HERITAGE PHARMA Labeling Approval
08/01/2013 LISINOPRIL
ANDA #075752		 SUPPL-30 LISINOPRIL HERITAGE PHARMA Labeling Approval
08/01/2013 LISINOPRIL
ANDA #075752		 SUPPL-32 LISINOPRIL HERITAGE PHARMA Labeling Approval
08/01/2013 LISINOPRIL
ANDA #075752		 SUPPL-35 LISINOPRIL HERITAGE PHARMA Labeling Approval
08/01/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-32 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
08/01/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-34 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
08/01/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-35 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
08/01/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-36 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
08/01/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-37 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
08/01/2013 GLIMEPIRIDE
ANDA #078952		 ORIG-1 GLIMEPIRIDE HIKMA PHARMS Approval
08/01/2013 PIMTREA
ANDA #091247		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL NOVAST LABS Approval
08/01/2013 NORETHINDRONE
ANDA #202260		 ORIG-1 NORETHINDRONE AMNEAL PHARMS Approval
08/02/2013 BUPHENYL
NDA #020572		 SUPPL-20 SODIUM PHENYLBUTYRATE HORIZON THERAP US Manufacturing (CMC) Approval
08/02/2013 VALSTAR PRESERVATIVE FREE
NDA #020892		 SUPPL-16 VALRUBICIN ENDO OPERATIONS Efficacy Approval
08/02/2013 CANCIDAS
NDA #021227		 SUPPL-30 CASPOFUNGIN ACETATE MERCK Labeling Approval
08/02/2013 FORTEO
NDA #021318		 SUPPL-35 TERIPARATIDE LILLY Manufacturing (CMC) Approval
08/02/2013 LEVITRA
NDA #021400		 SUPPL-16 VARDENAFIL HYDROCHLORIDE BAYER HLTHCARE Efficacy Approval
08/02/2013 MUCINEX D
NDA #021585		 SUPPL-29 GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE RECKITT BENCKISER Manufacturing (CMC) Approval
08/02/2013 VELCADE
NDA #021602		 SUPPL-35 BORTEZOMIB TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/02/2013 XENAZINE
NDA #021894		 SUPPL-9 TETRABENAZINE BAUSCH REMS Approval
08/02/2013 ZIANA
NDA #050802		 SUPPL-11 CLINDAMYCIN PHOSPHATE; TRETINOIN BAUSCH Manufacturing (CMC) Approval
08/02/2013 METRONIDAZOLE
ANDA #070035		 SUPPL-56 METRONIDAZOLE WATSON LABS Labeling Approval
08/02/2013 METRONIDAZOLE
ANDA #070044		 SUPPL-55 METRONIDAZOLE WATSON LABS INC Labeling Approval
08/02/2013 GABAPENTIN
ANDA #077261		 ORIG-1 GABAPENTIN TARO Approval
08/02/2013 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183		 SUPPL-9 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
08/02/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089673		 SUPPL-21 ACETAMINOPHEN; CODEINE PHOSPHATE RHODES PHARMS Labeling Approval
08/02/2013 CEPHALEXIN
ANDA #090836		 SUPPL-4 CEPHALEXIN ALKEM LABS LTD Manufacturing (CMC) Approval
08/02/2013 STAXYN
NDA #200179		 SUPPL-1 VARDENAFIL HYDROCHLORIDE BAYER HLTHCARE Efficacy Approval
08/02/2013 BINOSTO
NDA #202344		 SUPPL-2 ALENDRONATE SODIUM RADIUS Manufacturing (CMC) Approval
08/02/2013 ZOLEDRONIC ACID
NDA #203231		 ORIG-1 ZOLEDRONIC ACID INFORLIFE Type 5 - New Formulation or New Manufacturer Approval
08/02/2013 OXYGEN, USP
NDA #205889		 ORIG-1 OXYGEN MATHESON TRI-GAS INC Medical Gas Approval
08/02/2013 MEDICAL AIR, USP
NDA #205890		 ORIG-1 MEDICAL AIR MATHESON TRI-GAS INC Medical Gas Approval
08/02/2013 NITROGEN, NF
NDA #205891		 ORIG-1 NITROGEN MATHESON TRI-GAS INC Medical Gas Approval
08/05/2013 LOCOID
NDA #018514		 SUPPL-11 HYDROCORTISONE BUTYRATE BAUSCH Manufacturing (CMC) Approval
08/05/2013 CERETEC
NDA #019829		 SUPPL-26 TECHNETIUM TC-99M EXAMETAZIME KIT GE HEALTHCARE Labeling Approval
08/05/2013 BUPHENYL
NDA #020573		 SUPPL-19 SODIUM PHENYLBUTYRATE HORIZON THERAP US Manufacturing (CMC) Approval
08/05/2013 INVANZ
NDA #021337		 SUPPL-40 ERTAPENEM SODIUM MSD SUB MERCK Manufacturing (CMC) Approval
08/05/2013 STRATTERA
NDA #021411		 SUPPL-40 ATOMOXETINE HYDROCHLORIDE LILLY Labeling Approval
08/05/2013 STRATTERA
NDA #021411		 SUPPL-42 ATOMOXETINE HYDROCHLORIDE LILLY Labeling Approval
08/05/2013 VELCADE
NDA #021602		 SUPPL-36 BORTEZOMIB TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/05/2013 ISENTRESS
NDA #022145		 SUPPL-29 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
08/05/2013 ISENTRESS HD
NDA #022145		 SUPPL-29 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
08/05/2013 CARBAGLU
NDA #022562		 SUPPL-2 CARGLUMIC ACID RECORDATI RARE Labeling Approval
08/05/2013 PYLERA
NDA #050786		 SUPPL-8 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE Manufacturing (CMC) Approval
08/05/2013 ERY-TAB
ANDA #062298		 SUPPL-69 ERYTHROMYCIN CARNEGIE Labeling Approval
08/05/2013 LISINOPRIL
ANDA #075944		 SUPPL-20 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL
ANDA #075944		 SUPPL-21 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL
ANDA #075944		 SUPPL-22 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL
ANDA #075944		 SUPPL-23 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076007		 SUPPL-12 HYDROCHLOROTHIAZIDE; LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076007		 SUPPL-13 HYDROCHLOROTHIAZIDE; LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076007		 SUPPL-14 HYDROCHLOROTHIAZIDE; LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076007		 SUPPL-15 HYDROCHLOROTHIAZIDE; LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/05/2013 LISINOPRIL
ANDA #076063		 SUPPL-40 LISINOPRIL HIKMA INTL PHARMS Manufacturing (CMC) Approval
08/05/2013 ZOLEDRONIC ACID
ANDA #202163		 ORIG-1 ZOLEDRONIC ACID CHARTWELL RX Approval
08/05/2013 ZOLEDRONIC ACID
ANDA #202930		 ORIG-1 ZOLEDRONIC ACID GLAND Approval
08/05/2013 NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #203006		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE XIROMED Approval
08/05/2013 ISENTRESS
NDA #203045		 SUPPL-7 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
08/05/2013 FLUDEOXYGLUCOSE F18
ANDA #203612		 ORIG-1 FLUDEOXYGLUCOSE F-18 MCPRF Approval
08/05/2013 MEDICAL AIR, USP
NDA #205909		 ORIG-1 MEDICAL AIR PRAXAIR DISTRIBUTION INC Medical Gas Approval
08/05/2013 MEDICAL AIR, USP
NDA #205910		 ORIG-1 MEDICAL AIR PRAXAIR DISTRIBUTION MID-ATLANTIC LLC Medical Gas Approval
08/05/2013 HELIUM, USP
NDA #205911		 ORIG-1 HELIUM PRAXAIR DISTRIBUTION MID-ATLANTIC LLC Medical Gas Approval
08/05/2013 HELIUM, USP
NDA #205912		 ORIG-1 HELIUM PRAXAIR DISTRIBUTION INC Medical Gas Approval
08/06/2013 ANZEMET
NDA #020623		 SUPPL-11 DOLASETRON MESYLATE VALIDUS PHARMS Manufacturing (CMC) Approval
08/06/2013 FEMCON FE
NDA #021490		 SUPPL-13 ETHINYL ESTRADIOL; NORETHINDRONE APIL Manufacturing (CMC) Approval
08/06/2013 ABELCET
NDA #050724		 SUPPL-16 AMPHOTERICIN B LEADIANT BIOSCI INC Manufacturing (CMC) Approval
08/06/2013 FENOFIBRATE
ANDA #076433		 SUPPL-6 FENOFIBRATE RHODES PHARMS Labeling Approval
08/06/2013 DILANTIN
ANDA #084349		 SUPPL-70 PHENYTOIN SODIUM VIATRIS Labeling Approval
08/06/2013 DILANTIN
ANDA #084427		 SUPPL-28 PHENYTOIN PHARMACIA Labeling Approval
08/06/2013 GRANISETRON HYDROCHLORIDE
ANDA #091136		 SUPPL-3 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
08/06/2013 GRANISETRON HYDROCHLORIDE
ANDA #091136		 SUPPL-6 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
08/06/2013 GRANISETRON HYDROCHLORIDE
ANDA #091137		 SUPPL-4 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
08/06/2013 GRANISETRON HYDROCHLORIDE
ANDA #091137		 SUPPL-6 GRANISETRON HYDROCHLORIDE MYLAN ASI Labeling Approval
08/06/2013 MONTELUKAST SODIUM
ANDA #201581		 SUPPL-4 MONTELUKAST SODIUM SENORES PHARMS Labeling Approval
08/06/2013 MONTELUKAST SODIUM
ANDA #201582		 SUPPL-5 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
08/06/2013 STENDRA
NDA #202276		 SUPPL-3 AVANAFIL VIVUS LLC Manufacturing (CMC) Approval
08/06/2013 ESOMEPRAZOLE STRONTIUM
NDA #202342		 ORIG-1 ESOMEPRAZOLE STRONTIUM BELCHER Type 2 - New Active Ingredient Approval
08/07/2013 AMMONUL
NDA #020645		 SUPPL-9 SODIUM BENZOATE; SODIUM PHENYLACETATE BAUSCH Manufacturing (CMC) Approval
08/07/2013 MIRENA
NDA #021225		 SUPPL-32 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
08/07/2013 NICORETTE
NDA #021330		 SUPPL-15 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
08/07/2013 CRESTOR
NDA #021366		 SUPPL-28 ROSUVASTATIN CALCIUM ASTRAZENECA Labeling Approval
08/07/2013 CRESTOR
NDA #021366		 SUPPL-29 ROSUVASTATIN CALCIUM ASTRAZENECA Labeling Approval
08/07/2013 SYMBYAX
NDA #021520		 SUPPL-40 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
08/07/2013 ABLAVAR
NDA #021711		 SUPPL-4 GADOFOSVESET TRISODIUM LANTHEUS MEDCL Labeling Approval
08/07/2013 COSYNTROPIN
NDA #022028		 SUPPL-4 COSYNTROPIN SANDOZ Manufacturing (CMC) Approval
08/07/2013 ATOMOXETINE HYDROCHLORIDE
ANDA #079017		 SUPPL-2 ATOMOXETINE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
08/07/2013 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-6 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
08/07/2013 GRISEOFULVIN
ANDA #091592		 ORIG-1 GRISEOFULVIN, MICROSIZE SANDOZ Approval
08/07/2013 XARELTO
NDA #202439		 SUPPL-8 RIVAROXABAN JANSSEN PHARMS Labeling Approval
08/07/2013 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-3 LEVETIRACETAM HQ SPCLT PHARMA Manufacturing (CMC) Approval
08/07/2013 SKYLA
NDA #203159		 SUPPL-1 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
08/08/2013 DILANTIN-125
NDA #008762		 SUPPL-48 PHENYTOIN VIATRIS Manufacturing (CMC) Approval
08/08/2013 DILANTIN-30
NDA #008762		 SUPPL-48 PHENYTOIN VIATRIS Manufacturing (CMC) Approval
08/08/2013 BUPRENEX
NDA #018401		 SUPPL-19 BUPRENORPHINE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
08/08/2013 SUBUTEX
NDA #020732		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
08/08/2013 SUBOXONE
NDA #020733		 SUPPL-11 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
08/08/2013 SUBOXONE
NDA #022410		 SUPPL-11 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
08/08/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #077854		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE NATCO Labeling Approval
08/08/2013 ONDANSETRON HYDROCHLORIDE
ANDA #090116		 SUPPL-4 ONDANSETRON HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
08/08/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090764		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE NATCO PHARMA Labeling Approval
08/08/2013 ONDANSETRON HYDROCHLORIDE
ANDA #090883		 SUPPL-4 ONDANSETRON HYDROCHLORIDE LANNETT CO INC Labeling Approval
08/08/2013 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091397		 ORIG-1 LEVOFLOXACIN BAXTER HLTHCARE CORP Approval
08/08/2013 DISULFIRAM
ANDA #091681		 ORIG-1 DISULFIRAM ALVOGEN Approval
08/08/2013 LINZESS
NDA #202811		 SUPPL-3 LINACLOTIDE ABBVIE Labeling Approval
08/09/2013 ALOPRIM
NDA #020298		 SUPPL-5 ALLOPURINOL SODIUM MYLAN Manufacturing (CMC) Approval
08/09/2013 DEPOCYT
NDA #021041		 SUPPL-26 CYTARABINE PACIRA PHARMS INC Manufacturing (CMC) Approval
08/09/2013 ENABLEX
NDA #021513		 SUPPL-12 DARIFENACIN HYDROBROMIDE ABBVIE Manufacturing (CMC) Approval
08/09/2013 LIALDA
NDA #022000		 SUPPL-8 MESALAMINE TAKEDA PHARMS USA Labeling Approval
08/09/2013 LIALDA
NDA #022000		 SUPPL-10 MESALAMINE TAKEDA PHARMS USA Labeling Approval
08/09/2013 ZANOSAR
NDA #050577		 SUPPL-36 STREPTOZOCIN TEVA PHARMS USA Manufacturing (CMC) Approval
08/09/2013 QUILLIVANT XR
NDA #202100		 SUPPL-2 METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE Labeling Approval
08/09/2013 FLUOCINOLONE ACETONIDE
ANDA #202847		 ORIG-1 FLUOCINOLONE ACETONIDE PADAGIS ISRAEL Approval
08/09/2013 FLUOCINOLONE ACETONIDE
ANDA #202848		 ORIG-1 FLUOCINOLONE ACETONIDE PADAGIS ISRAEL Approval
08/12/2013 GELNIQUE
NDA #022204		 SUPPL-7 OXYBUTYNIN CHLORIDE ABBVIE Manufacturing (CMC) Approval
08/12/2013 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
NDA #022573		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/12/2013 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
NDA #022573		 SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/12/2013 IRINOTECAN HYDROCHLORIDE
ANDA #077776		 SUPPL-3 IRINOTECAN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/12/2013 AMIODARONE HYDROCHLORIDE
ANDA #077834		 SUPPL-2 AMIODARONE HYDROCHLORIDE ACELLA Labeling Approval
08/12/2013 ICLUSIG
NDA #203469		 SUPPL-3 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/12/2013 TIVICAY
NDA #204790		 ORIG-1 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Type 1 - New Molecular Entity Approval
08/13/2013 MONISTAT 7
NDA #017450		 SUPPL-64 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
08/13/2013 BREVIBLOC
NDA #019386		 SUPPL-41 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/13/2013 BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
NDA #019386		 SUPPL-41 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/13/2013 BREVIBLOC IN PLASTIC CONTAINER
NDA #019386		 SUPPL-41 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/13/2013 PROHANCE
NDA #020131		 SUPPL-26 GADOTERIDOL BRACCO Labeling Approval
08/13/2013 GONAL-F
BLA #020378		 SUPPL-42 FOLLITROPIN ALFA/BETA EMD SERONO Approval
08/13/2013 GEODON
NDA #020825		 SUPPL-47 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
08/13/2013 GEODON
NDA #020919		 SUPPL-32 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
08/13/2013 GEODON
NDA #021483		 SUPPL-10 ZIPRASIDONE HYDROCHLORIDE PFIZER INC Labeling Approval
08/13/2013 PROHANCE MULTIPACK
NDA #021489		 SUPPL-3 GADOTERIDOL BRACCO Labeling Approval
08/13/2013 CONZIP
NDA #022370		 SUPPL-9 TRAMADOL HYDROCHLORIDE CIPHER PHARMS INC Manufacturing (CMC) Approval
08/13/2013 DUEXIS
NDA #022519		 SUPPL-4 FAMOTIDINE; IBUPROFEN HORIZON Manufacturing (CMC) Approval
08/13/2013 OFLOXACIN
ANDA #076182		 SUPPL-9 OFLOXACIN TEVA REMS Approval
08/13/2013 OFLOXACIN
ANDA #076182		 SUPPL-11 OFLOXACIN TEVA Labeling Approval
08/13/2013 OFLOXACIN
ANDA #076616		 SUPPL-3 OFLOXACIN HIKMA Labeling Approval
08/13/2013 IBUPROFEN
ANDA #076925		 SUPPL-29 IBUPROFEN PADAGIS US Labeling Approval
08/13/2013 OFLOXACIN
ANDA #077098		 SUPPL-5 OFLOXACIN DR REDDYS LABS LTD REMS Approval
08/13/2013 OFLOXACIN
ANDA #077098		 SUPPL-7 OFLOXACIN DR REDDYS LABS LTD REMS Approval
08/13/2013 OFLOXACIN
ANDA #077098		 SUPPL-8 OFLOXACIN DR REDDYS LABS LTD REMS Approval
08/13/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #085082		 SUPPL-37 DICYCLOMINE HYDROCHLORIDE WATSON LABS Labeling Approval
08/13/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #085223		 SUPPL-43 DICYCLOMINE HYDROCHLORIDE WATSON LABS Labeling Approval
08/13/2013 WARFARIN SODIUM
ANDA #090935		 SUPPL-1 WARFARIN SODIUM INVAGEN PHARMS Labeling Approval
08/13/2013 BUPROPION HYDROBROMIDE
ANDA #200835		 ORIG-1 BUPROPION HYDROBROMIDE WATSON LABS INC Tentative Approval
08/13/2013 OSPHENA
NDA #203505		 SUPPL-1 OSPEMIFENE DUCHESNAY Manufacturing (CMC) Approval
08/13/2013 JUXTAPID
NDA #203858		 SUPPL-1 LOMITAPIDE MESYLATE CHIESI REMS Approval
08/13/2013 EPANED KIT
NDA #204308		 ORIG-1 ENALAPRIL MALEATE AZURITY Type 3 - New Dosage Form Approval
08/14/2013 GLEOSTINE
NDA #017588		 SUPPL-38 LOMUSTINE AZURITY Manufacturing (CMC) Approval
08/14/2013 NOROXIN
NDA #019384		 SUPPL-66 NORFLOXACIN MERCK Labeling Approval
08/14/2013 CIPRO
NDA #019537		 SUPPL-82 CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
08/14/2013 CIPRO
NDA #019847		 SUPPL-54 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
08/14/2013 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-62 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
08/14/2013 MORPHINE SULFATE (AUTOINJECTOR)
NDA #019999		 SUPPL-19 MORPHINE SULFATE MERIDIAN MEDCL TECHN Manufacturing (CMC) Approval
08/14/2013 LEVAQUIN
NDA #020634		 SUPPL-65 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
08/14/2013 LEVAQUIN
NDA #020635		 SUPPL-71 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
08/14/2013 LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020635		 SUPPL-71 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
08/14/2013 CIPRO
NDA #020780		 SUPPL-40 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
08/14/2013 LANTUS
BLA #021081		 SUPPL-49 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
08/14/2013 LANTUS SOLOSTAR
BLA #021081		 SUPPL-49 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
08/14/2013 AVELOX
NDA #021085		 SUPPL-57 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
08/14/2013 FACTIVE
NDA #021158		 SUPPL-22 GEMIFLOXACIN MESYLATE LG CHEM LTD Labeling Approval
08/14/2013 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
NDA #021277		 SUPPL-54 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
08/14/2013 CIPRO XR
NDA #021473		 SUPPL-35 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
08/14/2013 LEVAQUIN
NDA #021721		 SUPPL-32 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
08/14/2013 TASIGNA
NDA #022068		 SUPPL-15 NILOTINIB HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
08/14/2013 VOTRIENT
NDA #022465		 SUPPL-14 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
08/14/2013 VOTRIENT
NDA #022465		 SUPPL-15 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
08/14/2013 VOTRIENT
NDA #022465		 SUPPL-16 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
08/14/2013 ZINACEF
NDA #050558		 SUPPL-72 CEFUROXIME SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
08/14/2013 PYLERA
NDA #050786		 SUPPL-9 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE Manufacturing (CMC) Approval
08/14/2013 LISINOPRIL
ANDA #075994		 SUPPL-35 LISINOPRIL CHARTWELL RX Labeling Approval
08/14/2013 LISINOPRIL
ANDA #076059		 SUPPL-46 LISINOPRIL WATSON LABS Labeling Approval
08/14/2013 LISINOPRIL
ANDA #076063		 SUPPL-49 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
08/14/2013 OFLOXACIN
ANDA #076182		 SUPPL-12 OFLOXACIN TEVA Labeling Approval
08/14/2013 OFLOXACIN
ANDA #076182		 SUPPL-13 OFLOXACIN TEVA Labeling Approval
08/14/2013 OFLOXACIN
ANDA #077098		 SUPPL-9 OFLOXACIN DR REDDYS LABS LTD Labeling Approval
08/14/2013 CIPROFLOXACIN EXTENDED RELEASE
ANDA #077701		 SUPPL-10 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
08/14/2013 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078166		 SUPPL-8 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE PH HEALTH Labeling Approval
08/14/2013 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183		 SUPPL-11 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
08/14/2013 FOSPHENYTOIN SODIUM
ANDA #078765		 SUPPL-5 FOSPHENYTOIN SODIUM HIKMA FARMACEUTICA Labeling Approval
08/14/2013 MONTELUKAST SODIUM
ANDA #090984		 SUPPL-3 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
08/14/2013 MONTELUKAST SODIUM
ANDA #201294		 SUPPL-4 MONTELUKAST SODIUM APOTEX CORP Labeling Approval
08/14/2013 NITROFURANTOIN
ANDA #201355		 ORIG-1 NITROFURANTOIN STRIDES PHARMA Approval
08/14/2013 MONTELUKAST SODIUM
ANDA #201508		 SUPPL-4 MONTELUKAST SODIUM APOTEX INC Labeling Approval
08/14/2013 MORPHINE SULFATE
NDA #202515		 SUPPL-3 MORPHINE SULFATE HOSPIRA INC Manufacturing (CMC) Approval
08/14/2013 MONTELUKAST SODIUM
ANDA #202906		 SUPPL-3 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
08/15/2013 GLEOSTINE
NDA #017588		 SUPPL-39 LOMUSTINE AZURITY Labeling Approval
08/15/2013 HUMULIN R
BLA #018780		 SUPPL-145 INSULIN HUMAN LILLY Approval
08/15/2013 HUMULIN R
BLA #018780		 SUPPL-145 INSULIN RECOMBINANT HUMAN LILLY Approval
08/15/2013 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-145 INSULIN HUMAN LILLY Approval
08/15/2013 HUMULIN R PEN
BLA #018780		 SUPPL-145 INSULIN RECOMBINANT HUMAN LILLY Approval
08/15/2013 HUMULIN N
BLA #018781		 SUPPL-136 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/15/2013 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-49 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/15/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-49 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/15/2013 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-49 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/15/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-49 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/15/2013 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-49 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/15/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-49 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/15/2013 HUMULIN 70/30
BLA #019717		 SUPPL-115 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/15/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-115 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/15/2013 TAXOTERE
NDA #020449		 SUPPL-70 DOCETAXEL SANOFI AVENTIS US Manufacturing (CMC) Approval
08/15/2013 HUMALOG
BLA #020563		 SUPPL-142 INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-142 INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG PEN
BLA #020563		 SUPPL-142 INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-142 INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-94 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-94 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-94 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG MIX 50/50
BLA #021018		 SUPPL-88 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-88 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-88 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
08/15/2013 GLUCOVANCE
NDA #021178		 SUPPL-14 GLYBURIDE; METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
08/15/2013 REYATAZ
NDA #021567		 SUPPL-32 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
08/15/2013 REYATAZ
NDA #021567		 SUPPL-33 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
08/15/2013 TRUVADA
NDA #021752		 SUPPL-37 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing (CMC) Approval
08/15/2013 ACTOPLUS MET
NDA #021842		 SUPPL-18 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/15/2013 NESINA
NDA #022271		 SUPPL-3 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/15/2013 OSENI
NDA #022426		 SUPPL-1 ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/15/2013 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #075929		 SUPPL-11 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE PHARMOBEDIENT Labeling Approval
08/15/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090151		 SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE PHARMOBEDIENT Labeling Approval
08/15/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090151		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE PHARMOBEDIENT Labeling Approval
08/15/2013 MECLIZINE HYDROCHLORIDE
ANDA #201451		 SUPPL-2 MECLIZINE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
08/15/2013 ADVIL
NDA #201803		 SUPPL-1 IBUPROFEN SODIUM HALEON US HOLDINGS Manufacturing (CMC) Approval
08/15/2013 SUCLEAR
NDA #203595		 SUPPL-1 MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE BRAINTREE LABS Manufacturing (CMC) Approval
08/15/2013 SUCLEAR
NDA #203595		 SUPPL-2 MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE BRAINTREE LABS Manufacturing (CMC) Approval
08/16/2013 FLAGYL
NDA #012623		 SUPPL-65 METRONIDAZOLE PFIZER Labeling Approval
08/16/2013 DIABETA
NDA #017532		 SUPPL-35 GLYBURIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
08/16/2013 FLAGYL I.V.
NDA #018353		 SUPPL-26 METRONIDAZOLE HYDROCHLORIDE PFIZER Labeling Approval
08/16/2013 FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018353		 SUPPL-26 METRONIDAZOLE PFIZER Labeling Approval
08/16/2013 FLAGYL
NDA #020334		 SUPPL-8 METRONIDAZOLE PFIZER Labeling Approval
08/16/2013 GLIADEL
NDA #020637		 SUPPL-26 CARMUSTINE AZURITY Labeling Approval
08/16/2013 FLAGYL ER
NDA #020868		 SUPPL-9 METRONIDAZOLE PFIZER Labeling Approval
08/16/2013 OMEPRAZOLE
NDA #022032		 SUPPL-21 OMEPRAZOLE DEXCEL PHARMA Labeling Approval
08/16/2013 FIRMAGON
NDA #022201		 SUPPL-3 DEGARELIX ACETATE FERRING Labeling Approval
08/16/2013 BESIVANCE
NDA #022308		 SUPPL-5 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
08/16/2013 PROGRAF
NDA #050709		 SUPPL-35 TACROLIMUS ASTELLAS Manufacturing (CMC) Approval
08/16/2013 TOBRAMYCIN SULFATE
ANDA #065013		 SUPPL-12 TOBRAMYCIN SULFATE XGEN PHARMS Labeling Approval
08/16/2013 AMIODARONE HYDROCHLORIDE
ANDA #075955		 SUPPL-15 AMIODARONE HYDROCHLORIDE HOSPIRA Labeling Approval
08/16/2013 LISINOPRIL
ANDA #076102		 SUPPL-10 LISINOPRIL COREPHARMA Labeling Approval
08/16/2013 BUPROPION HYDROCHLORIDE
ANDA #077475		 SUPPL-14 BUPROPION HYDROCHLORIDE SANDOZ Labeling Approval
08/16/2013 FOSPHENYTOIN SODIUM
ANDA #078736		 SUPPL-2 FOSPHENYTOIN SODIUM PHARMOBEDIENT Labeling Approval
08/16/2013 AMIODARONE HYDROCHLORIDE
ANDA #079029		 SUPPL-7 AMIODARONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
08/16/2013 BUPROPION HYDROCHLORIDE
ANDA #079094		 SUPPL-12 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
08/16/2013 NIFEDIPINE
ANDA #090649		 SUPPL-6 NIFEDIPINE AUROBINDO PHARMA USA Labeling Approval
08/16/2013 BUPROPION HYDROCHLORIDE
ANDA #091520		 SUPPL-5 BUPROPION HYDROCHLORIDE PH HEALTH Labeling Approval
08/16/2013 PROGESTERONE
ANDA #200900		 ORIG-1 PROGESTERONE BIONPHARMA Approval
08/16/2013 TROKENDI XR
NDA #201635		 ORIG-1 TOPIRAMATE SUPERNUS PHARMS Type 3 - New Dosage Form Approval
08/16/2013 OXYTROL FOR WOMEN
NDA #202211		 SUPPL-2 OXYBUTYNIN ABBVIE Manufacturing (CMC) Approval
08/17/2013 LETAIRIS
NDA #022081		 SUPPL-19 AMBRISENTAN GILEAD REMS Approval
08/19/2013 COLYTE
NDA #018983		 SUPPL-47 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA INTL Labeling Approval
08/19/2013 COLYTE WITH FLAVOR PACKS
NDA #018983		 SUPPL-47 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA INTL Labeling Approval
08/19/2013 COLYTE-FLAVORED
NDA #018983		 SUPPL-47 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA INTL Labeling Approval
08/19/2013 URSO 250
NDA #020675		 SUPPL-23 URSODIOL ABBVIE Manufacturing (CMC) Approval
08/19/2013 URSO FORTE
NDA #020675		 SUPPL-23 URSODIOL ABBVIE Manufacturing (CMC) Approval
08/19/2013 AMITIZA
NDA #021908		 SUPPL-12 LUBIPROSTONE SUCAMPO PHARMA LLC Manufacturing (CMC) Approval
08/19/2013 JANUVIA
NDA #021995		 SUPPL-29 SITAGLIPTIN PHOSPHATE MSD Labeling Approval
08/19/2013 ERYTHROCIN
NDA #050609		 SUPPL-34 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
08/19/2013 PAROXETINE HYDROCHLORIDE
ANDA #077584		 SUPPL-22 PAROXETINE HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
08/19/2013 PAROXETINE HYDROCHLORIDE
ANDA #077584		 SUPPL-25 PAROXETINE HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
08/19/2013 FOSPHENYTOIN SODIUM
ANDA #078277		 SUPPL-2 FOSPHENYTOIN SODIUM AM REGENT Labeling Approval
08/19/2013 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #078374		 SUPPL-6 METOCLOPRAMIDE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
08/19/2013 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #078374		 SUPPL-7 METOCLOPRAMIDE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
08/19/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090190		 SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE SANDOZ Labeling Approval
08/19/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090190		 SUPPL-12 PRAMIPEXOLE DIHYDROCHLORIDE SANDOZ Labeling Approval
08/19/2013 ADCETRIS
BLA #125388		 SUPPL-45 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
08/19/2013 KADCYLA
BLA #125427		 SUPPL-12 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
08/19/2013 JUVISYNC
NDA #202343		 SUPPL-10 SIMVASTATIN; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
08/19/2013 LANSOPRAZOLE
ANDA #202366		 ORIG-1 LANSOPRAZOLE ZYDUS HLTHCARE Approval
08/20/2013 DEXILANT
NDA #022287		 SUPPL-17 DEXLANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
08/20/2013 ZOSYN
NDA #050684		 SUPPL-79 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Manufacturing (CMC) Approval
08/20/2013 ZIANA
NDA #050802		 SUPPL-13 CLINDAMYCIN PHOSPHATE; TRETINOIN BAUSCH Manufacturing (CMC) Approval
08/20/2013 LISINOPRIL
ANDA #077622		 SUPPL-17 LISINOPRIL AUROBINDO Labeling Approval
08/20/2013 MONTELUKAST SODIUM
ANDA #200405		 SUPPL-3 MONTELUKAST SODIUM LANNETT CO INC Labeling Approval
08/20/2013 OXYTROL FOR WOMEN
NDA #202211		 SUPPL-1 OXYBUTYNIN ABBVIE Manufacturing (CMC) Approval
08/20/2013 TECFIDERA
NDA #204063		 SUPPL-2 DIMETHYL FUMARATE BIOGEN Manufacturing (CMC) Approval
08/21/2013 PROCALAMINE
NDA #018582		 SUPPL-47 AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/21/2013 HUMULIN N
BLA #018781		 SUPPL-132 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/21/2013 OMNIPAQUE 12
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 140
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 180
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 210
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 240
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 300
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 350
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 70
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 OMNIPAQUE 9
NDA #018956		 SUPPL-89 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
08/21/2013 HUMULIN 70/30
BLA #019717		 SUPPL-111 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/21/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-111 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/21/2013 HUMALOG
BLA #020563		 SUPPL-139 INSULIN LISPRO RECOMBINANT LILLY Approval
08/21/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-139 INSULIN LISPRO RECOMBINANT LILLY Approval
08/21/2013 HUMALOG PEN
BLA #020563		 SUPPL-139 INSULIN LISPRO RECOMBINANT LILLY Approval
08/21/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-139 INSULIN LISPRO RECOMBINANT LILLY Approval
08/21/2013 URSO 250
NDA #020675		 SUPPL-24 URSODIOL ABBVIE Manufacturing (CMC) Approval
08/21/2013 URSO FORTE
NDA #020675		 SUPPL-24 URSODIOL ABBVIE Manufacturing (CMC) Approval
08/21/2013 CRINONE
NDA #020701		 SUPPL-26 PROGESTERONE ABBVIE Manufacturing (CMC) Approval
08/21/2013 TRUVADA
NDA #021752		 SUPPL-38 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing (CMC) Approval
08/21/2013 LYSTEDA
NDA #022430		 SUPPL-3 TRANEXAMIC ACID J MOLNER Labeling Approval
08/21/2013 DULERA
NDA #022518		 SUPPL-13 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
08/21/2013 CEFAZOLIN AND DEXTROSE
NDA #050779		 SUPPL-22 CEFAZOLIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/21/2013 FOSPHENYTOIN SODIUM
ANDA #078417		 SUPPL-2 FOSPHENYTOIN SODIUM SUN PHARM Labeling Approval
08/21/2013 SULFASALAZINE
ANDA #085828		 SUPPL-36 SULFASALAZINE WATSON LABS Labeling Approval
08/21/2013 RIFAMPIN
ANDA #090034		 ORIG-1 RIFAMPIN LUPIN PHARMS Approval
08/21/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #201674		 ORIG-1 HYDROXYZINE HYDROCHLORIDE LANNETT CO INC Approval
08/22/2013 OMNITROPE
BLA #021426		 SUPPL-27 SOMATROPIN SANDOZ Approval
08/22/2013 NATAZIA
NDA #022252		 SUPPL-3 DIENOGEST; ESTRADIOL VALERATE BAYER HLTHCARE Labeling Approval
08/22/2013 LISINOPRIL
ANDA #077622		 SUPPL-18 LISINOPRIL AUROBINDO Labeling Approval
08/22/2013 FOSPHENYTOIN SODIUM
ANDA #078052		 SUPPL-2 FOSPHENYTOIN SODIUM FRESENIUS KABI USA Labeling Approval
08/22/2013 OXYCODONE HYDROCHLORIDE
NDA #200535		 SUPPL-6 OXYCODONE HYDROCHLORIDE GENUS LIFESCIENCES Labeling Approval
08/22/2013 OXYCODONE HYDROCHLORIDE
NDA #200535		 SUPPL-8 OXYCODONE HYDROCHLORIDE GENUS LIFESCIENCES Manufacturing (CMC) Approval
08/22/2013 MONTELUKAST SODIUM
ANDA #201522		 SUPPL-4 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
08/22/2013 HALAVEN
NDA #201532		 SUPPL-6 ERIBULIN MESYLATE EISAI INC Labeling Approval
08/22/2013 VERSACLOZ
NDA #203479		 SUPPL-2 CLOZAPINE DOUGLAS PHARMS Labeling Approval
08/23/2013 DESOXYN
NDA #005378		 SUPPL-27 METHAMPHETAMINE HYDROCHLORIDE AJENAT PHARMS Labeling Approval
08/23/2013 NUVIGIL
NDA #021875		 SUPPL-19 ARMODAFINIL NUVO PHARMS Manufacturing (CMC) Approval
08/23/2013 RELISTOR
NDA #021964		 SUPPL-11 METHYLNALTREXONE BROMIDE SALIX PHARMS Labeling Approval
08/23/2013 INTUNIV
NDA #022037		 SUPPL-9 GUANFACINE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
08/23/2013 NEXTERONE
NDA #022325		 SUPPL-7 AMIODARONE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/23/2013 MIRAPEX ER
NDA #022421		 SUPPL-9 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
08/23/2013 DALIRESP
NDA #022522		 SUPPL-3 ROFLUMILAST ASTRAZENECA Labeling Approval
08/23/2013 MIRTAZAPINE
ANDA #076219		 SUPPL-20 MIRTAZAPINE CHARTWELL RX Labeling Approval
08/23/2013 REPAGLINIDE
ANDA #090252		 ORIG-1 REPAGLINIDE QUAGEN Approval
08/23/2013 LARIN FE 1.5/30
ANDA #091453		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Approval
08/23/2013 PROLIA
BLA #125320		 SUPPL-114 DENOSUMAB AMGEN Approval
08/23/2013 PROLIA
BLA #125320		 SUPPL-124 DENOSUMAB AMGEN Approval
08/23/2013 XGEVA
BLA #125320		 SUPPL-114 DENOSUMAB AMGEN Approval
08/23/2013 XGEVA
BLA #125320		 SUPPL-124 DENOSUMAB AMGEN Approval
08/23/2013 VALCHLOR
NDA #202317		 ORIG-1 MECHLORETHAMINE HYDROCHLORIDE HELSINN Type 5 - New Formulation or New Manufacturer Approval
08/23/2013 DACTINOMYCIN
ANDA #202562		 ORIG-1 DACTINOMYCIN AM REGENT Approval
08/23/2013 MONTELUKAST SODIUM
ANDA #202717		 SUPPL-3 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
08/23/2013 OXTELLAR XR
NDA #202810		 SUPPL-2 OXCARBAZEPINE SUPERNUS PHARMS Manufacturing (CMC) Approval
08/23/2013 MIRVASO
NDA #204708		 ORIG-1 BRIMONIDINE TARTRATE GALDERMA LABS LP Type 3 - New Dosage Form Approval
08/26/2013 BETADINE
NDA #018634		 SUPPL-13 POVIDONE-IODINE ALCON PHARMS LTD Manufacturing (CMC) Approval
08/26/2013 ETHYOL
NDA #020221		 SUPPL-28 AMIFOSTINE LEGACY Manufacturing (CMC) Approval
08/26/2013 OPTIMARK
NDA #020937		 SUPPL-22 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
08/26/2013 OPTIMARK
NDA #020975		 SUPPL-23 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
08/26/2013 OPTIMARK IN PLASTIC CONTAINER
NDA #020976		 SUPPL-24 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
08/26/2013 INVEGA SUSTENNA
NDA #022264		 SUPPL-11 PALIPERIDONE PALMITATE JANSSEN PHARMS Manufacturing (CMC) Approval
08/26/2013 ERYTHROCIN
ANDA #062638		 SUPPL-29 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
08/26/2013 CLOZAPINE
ANDA #074949		 SUPPL-63 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
08/26/2013 CLOZAPINE
ANDA #075417		 SUPPL-33 CLOZAPINE MYLAN Labeling Approval
08/26/2013 AMLODIPINE BESYLATE
ANDA #076719		 SUPPL-8 AMLODIPINE BESYLATE COREPHARMA Labeling Approval
08/26/2013 AMLODIPINE BESYLATE
ANDA #076719		 SUPPL-9 AMLODIPINE BESYLATE COREPHARMA Labeling Approval
08/26/2013 AMLODIPINE BESYLATE
ANDA #077955		 SUPPL-3 AMLODIPINE BESYLATE INVAGEN PHARMS Labeling Approval
08/26/2013 AMLODIPINE BESYLATE
ANDA #077955		 SUPPL-5 AMLODIPINE BESYLATE INVAGEN PHARMS Labeling Approval
08/26/2013 AMLODIPINE BESYLATE
ANDA #077955		 SUPPL-8 AMLODIPINE BESYLATE INVAGEN PHARMS Labeling Approval
08/26/2013 AMLODIPINE BESYLATE
ANDA #078043		 SUPPL-13 AMLODIPINE BESYLATE LUPIN Labeling Approval
08/26/2013 LARIN FE 1/20
ANDA #091454		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Approval
08/26/2013 REPAGLINIDE
ANDA #201189		 SUPPL-1 REPAGLINIDE PADAGIS US Labeling Approval
08/27/2013 HEPARIN SODIUM
NDA #017037		 SUPPL-170 HEPARIN SODIUM HIKMA Manufacturing (CMC) Approval
08/27/2013 OMNISCAN
NDA #020123		 SUPPL-39 GADODIAMIDE GE HEALTHCARE Labeling Approval
08/27/2013 ANTHELIOS SX
NDA #021502		 SUPPL-13 AVOBENZONE; ECAMSULE; OCTOCRYLENE LOREAL USA Manufacturing (CMC) Approval
08/27/2013 OMNISCAN
NDA #022066		 SUPPL-4 GADODIAMIDE GE HEALTHCARE Labeling Approval
08/27/2013 ONDANSETRON
ANDA #078139		 SUPPL-4 ONDANSETRON PHARMOBEDIENT Labeling Approval
08/27/2013 LANSOPRAZOLE
ANDA #090331		 SUPPL-12 LANSOPRAZOLE SANDOZ Labeling Approval
08/27/2013 LANSOPRAZOLE
ANDA #090763		 SUPPL-4 LANSOPRAZOLE MYLAN PHARMS INC Labeling Approval
08/27/2013 VANCOMYCIN HYDROCHLORIDE
ANDA #091469		 SUPPL-4 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/27/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #202289		 SUPPL-2 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
08/27/2013 NITROGEN, NF
NDA #205985		 ORIG-1 NITROGEN PRAXAIR CANADA INC Medical Gas Approval
08/27/2013 OXYGEN, USP
NDA #205986		 ORIG-1 OXYGEN PRAXAIR CANADA INC Medical Gas Approval
08/28/2013 ZEBETA
NDA #019982		 SUPPL-17 BISOPROLOL FUMARATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/28/2013 AEROSPAN HFA
NDA #021247		 SUPPL-8 FLUNISOLIDE PHARMOBEDIENT Efficacy Approval
08/28/2013 LEXIVA
NDA #021548		 SUPPL-30 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Manufacturing (CMC) Approval
08/28/2013 LIALDA
NDA #022000		 SUPPL-9 MESALAMINE TAKEDA PHARMS USA Labeling Approval
08/28/2013 TREANDA
NDA #022249		 SUPPL-14 BENDAMUSTINE HYDROCHLORIDE CEPHALON Labeling Approval
08/28/2013 DUEXIS
NDA #022519		 SUPPL-7 FAMOTIDINE; IBUPROFEN HORIZON Manufacturing (CMC) Approval
08/28/2013 MORPHINE SULFATE
ANDA #075295		 SUPPL-32 MORPHINE SULFATE STRIDES PHARMA INTL REMS Approval
08/28/2013 OLANZAPINE
ANDA #091265		 SUPPL-1 OLANZAPINE APOTEX INC Labeling Approval
08/28/2013 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-4 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
08/28/2013 ZIOPTAN
NDA #202514		 SUPPL-2 TAFLUPROST THEA PHARMA Manufacturing (CMC) Approval
08/28/2013 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202580		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE AUROLIFE PHARMA LLC Approval
08/28/2013 GATIFLOXACIN
ANDA #202653		 ORIG-1 GATIFLOXACIN LUPIN Approval
08/28/2013 SIRTURO
NDA #204384		 SUPPL-2 BEDAQUILINE FUMARATE JANSSEN THERAP Labeling Approval
08/28/2013 ACIPHEX SPRINKLE
NDA #204736		 SUPPL-1 RABEPRAZOLE SODIUM AYTU Manufacturing (CMC) Approval
08/29/2013 SINOGRAFIN
NDA #011324		 SUPPL-33 DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE BRACCO Manufacturing (CMC) Approval
08/29/2013 DIASTAT
NDA #020648		 SUPPL-9 DIAZEPAM BAUSCH Labeling Approval
08/29/2013 DIASTAT ACUDIAL
NDA #020648		 SUPPL-9 DIAZEPAM BAUSCH Labeling Approval
08/29/2013 NEORAL
NDA #050716		 SUPPL-35 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
08/29/2013 OXYBUTYNIN CHLORIDE
ANDA #076745		 SUPPL-10 OXYBUTYNIN CHLORIDE IMPAX PHARMS Labeling Approval
08/29/2013 ADENOSINE
ANDA #077425		 ORIG-1 ADENOSINE MEITHEAL Approval
08/29/2013 MIRTAZAPINE
ANDA #077666		 SUPPL-6 MIRTAZAPINE APOTEX Labeling Approval
08/29/2013 MIRTAZAPINE
ANDA #077666		 SUPPL-7 MIRTAZAPINE APOTEX Labeling Approval
08/29/2013 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091370		 SUPPL-1 HYDROCHLOROTHIAZIDE; IRBESARTAN ALEMBIC Labeling Approval
08/29/2013 TROSPIUM CHLORIDE
ANDA #091573		 SUPPL-3 TROSPIUM CHLORIDE PADAGIS US Labeling Approval
08/29/2013 KADCYLA
BLA #125427		 SUPPL-14 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
08/29/2013 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-1 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
08/29/2013 ADEFOVIR DIPIVOXIL
ANDA #202051		 ORIG-1 ADEFOVIR DIPIVOXIL SIGMAPHARM LABS LLC Approval
08/29/2013 TOPOTECAN HYDROCHLORIDE
ANDA #202203		 ORIG-1 TOPOTECAN HYDROCHLORIDE SUN PHARM INDS LTD Approval
08/29/2013 QNASL
NDA #202813		 SUPPL-3 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/30/2013 SEPTRA
NDA #017376		 SUPPL-60 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
08/30/2013 SEPTRA DS
NDA #017376		 SUPPL-60 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
08/30/2013 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-31 HEPARIN SODIUM B BRAUN Labeling Approval
08/30/2013 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-31 HEPARIN SODIUM B BRAUN Labeling Approval
08/30/2013 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-30 HEPARIN SODIUM B BRAUN Labeling Approval
08/30/2013 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-30 HEPARIN SODIUM B BRAUN Labeling Approval
08/30/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-30 HEPARIN SODIUM B BRAUN Labeling Approval
08/30/2013 CEREBYX
NDA #020450		 SUPPL-21 FOSPHENYTOIN SODIUM PARKE DAVIS Manufacturing (CMC) Approval
08/30/2013 ALORA
NDA #020655		 SUPPL-17 ESTRADIOL ABBVIE Manufacturing (CMC) Approval
08/30/2013 VANIQA
NDA #021145		 SUPPL-9 EFLORNITHINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
08/30/2013 FORTEO
NDA #021318		 SUPPL-36 TERIPARATIDE LILLY REMS Approval
08/30/2013 TESTIM
NDA #021454		 SUPPL-16 TESTOSTERONE ENDO OPERATIONS Labeling Approval
08/30/2013 CHLORHEXIDINE GLUCONATE
NDA #021669		 SUPPL-17 CHLORHEXIDINE GLUCONATE SAGE PRODS Manufacturing (CMC) Approval
08/30/2013 SUTENT
NDA #021938		 SUPPL-24 SUNITINIB MALATE CPPI CV Labeling Approval
08/30/2013 SUTENT
NDA #021938		 SUPPL-25 SUNITINIB MALATE CPPI CV Labeling Approval
08/30/2013 FIRAZYR
NDA #022150		 SUPPL-4 ICATIBANT ACETATE TAKEDA PHARMS USA Labeling Approval
08/30/2013 ASTEPRO
NDA #022203		 SUPPL-8 AZELASTINE HYDROCHLORIDE VIATRIS Efficacy Approval
08/30/2013 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-45 DOXORUBICIN HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
08/30/2013 CEFTRIAXONE IN PLASTIC CONTAINER
ANDA #065224		 SUPPL-8 CEFTRIAXONE SODIUM BAXTER HLTHCARE Labeling Approval
08/30/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076759		 SUPPL-8 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
08/30/2013 AMLODIPINE BESYLATE
ANDA #076846		 SUPPL-12 AMLODIPINE BESYLATE TEVA Labeling Approval
08/30/2013 ONDANSETRON HYDROCHLORIDE
ANDA #076876		 SUPPL-8 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
08/30/2013 RISPERIDONE
ANDA #077494		 SUPPL-11 RISPERIDONE PH HEALTH Labeling Approval
08/30/2013 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077969		 SUPPL-1 HYDROCHLOROTHIAZIDE; IRBESARTAN PHARMOBEDIENT Labeling Approval
08/30/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078244		 SUPPL-3 ONDANSETRON HYDROCHLORIDE ONESOURCE SPECIALTY Labeling Approval
08/30/2013 OXYBUTYNIN CHLORIDE
ANDA #078503		 SUPPL-3 OXYBUTYNIN CHLORIDE OSMOTICA PHARM US Labeling Approval
08/30/2013 OXYBUTYNIN CHLORIDE
ANDA #078503		 SUPPL-4 OXYBUTYNIN CHLORIDE OSMOTICA PHARM US Labeling Approval
08/30/2013 AMLODIPINE BESYLATE
ANDA #078552		 SUPPL-4 AMLODIPINE BESYLATE EPIC PHARMA LLC Labeling Approval
08/30/2013 AMLODIPINE BESYLATE
ANDA #078552		 SUPPL-5 AMLODIPINE BESYLATE EPIC PHARMA LLC Labeling Approval
08/30/2013 NARATRIPTAN
ANDA #090288		 SUPPL-2 NARATRIPTAN HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/30/2013 ROPINIROLE HYDROCHLORIDE
ANDA #090411		 SUPPL-2 ROPINIROLE HYDROCHLORIDE ZYDUS LIFESCIENCES Labeling Approval
08/30/2013 DOXERCALCIFEROL
ANDA #091101		 ORIG-1 DOXERCALCIFEROL HIKMA Approval
08/30/2013 NARATRIPTAN
ANDA #091373		 SUPPL-1 NARATRIPTAN HYDROCHLORIDE APOTEX CORP Labeling Approval
08/30/2013 NARATRIPTAN
ANDA #091552		 SUPPL-1 NARATRIPTAN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
08/30/2013 ZEVALIN
BLA #125019		 SUPPL-210 IBRITUMOMAB TIUXETAN SPECTRUM PHARMS Approval
08/30/2013 ZEVALIN
BLA #125019		 SUPPL-213 IBRITUMOMAB TIUXETAN SPECTRUM PHARMS Approval
08/30/2013 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 ORIG-1 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Approval
08/30/2013 LOSARTAN POTASSIUM
ANDA #200290		 ORIG-1 LOSARTAN POTASSIUM IPCA LABS LTD Approval
08/30/2013 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #202296		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL XIROMED Approval
08/31/2013 MEDICAL AIR, USP
NDA #205992		 ORIG-1 MEDICAL AIR UNITED STATES WELDING INC Medical Gas Approval
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