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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
September 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
09/01/2013 MEDICAL AIR, USP
NDA #205999		 ORIG-1 MEDICAL AIR ACETYLENE OXYGENE CO Medical Gas Approval
09/02/2013 FYCOMPA
NDA #202834		 SUPPL-2 PERAMPANEL CATALYST PHARMS Manufacturing (CMC) Approval
09/03/2013 LATUDA
NDA #200603		 SUPPL-16 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Labeling Approval
09/03/2013 NITROUS OXIDE, USP
NDA #206009		 ORIG-1 NITROUS OXIDE NITROUS OXIDE CORP Medical Gas Approval
09/04/2013 INFUVITE ADULT
NDA #021163		 SUPPL-25 ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K SANDOZ CANADA INC Manufacturing (CMC) Approval
09/04/2013 MINIRIN
NDA #021333		 SUPPL-9 DESMOPRESSIN ACETATE FERRING Manufacturing (CMC) Approval
09/04/2013 VIBRAMYCIN
NDA #050006		 SUPPL-85 DOXYCYCLINE PFIZER Labeling Approval
09/04/2013 VIBRAMYCIN
NDA #050007		 SUPPL-26 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
09/04/2013 VIBRAMYCIN
NDA #050480		 SUPPL-51 DOXYCYCLINE CALCIUM PFIZER Labeling Approval
09/04/2013 VIBRA-TABS
NDA #050533		 SUPPL-41 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
09/04/2013 PROGRAF
NDA #050708		 SUPPL-43 TACROLIMUS ASTELLAS Labeling Approval
09/04/2013 PROGRAF
NDA #050709		 SUPPL-36 TACROLIMUS ASTELLAS Labeling Approval
09/04/2013 ZOLPIDEM TARTRATE
ANDA #076410		 SUPPL-13 ZOLPIDEM TARTRATE TEVA Labeling Approval
09/04/2013 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #076447		 SUPPL-17 FEXOFENADINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
09/04/2013 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #076447		 SUPPL-17 FEXOFENADINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
09/04/2013 FEXOFENADINE HYDROCHLORIDE
ANDA #076447		 SUPPL-17 FEXOFENADINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
09/04/2013 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #076447		 SUPPL-17 FEXOFENADINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
09/04/2013 FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #076447		 SUPPL-17 FEXOFENADINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
09/04/2013 ZOLPIDEM TARTRATE
ANDA #077322		 SUPPL-12 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
09/04/2013 ZOLPIDEM TARTRATE
ANDA #078616		 SUPPL-7 ZOLPIDEM TARTRATE STRIDES PHARMA INTL Labeling Approval
09/04/2013 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-5 BUPRENORPHINE HYDROCHLORIDE HIKMA REMS Approval
09/04/2013 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE BARR REMS Approval
09/04/2013 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM REMS Approval
09/04/2013 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
09/04/2013 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 SUPPL-5 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS REMS Approval
09/04/2013 ZUBSOLV
NDA #204242		 SUPPL-2 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EDENBRIDGE PHARMS REMS Approval
09/05/2013 METOPIRONE
NDA #012911		 SUPPL-33 METYRAPONE ESTEVE Manufacturing (CMC) Approval
09/05/2013 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016367		 SUPPL-218 DEXTROSE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 NORMOSOL-R IN PLASTIC CONTAINER
NDA #017586		 SUPPL-127 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #017606		 SUPPL-141 DEXTROSE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017609		 SUPPL-127 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #017799		 SUPPL-130 DEXTROSE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
NDA #018233		 SUPPL-80 STERILE WATER FOR INJECTION OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #018365		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #018365		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #018365		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #018365		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #018365		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #018365		 SUPPL-91 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #018876		 SUPPL-45 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #018876		 SUPPL-45 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #018876		 SUPPL-45 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #018876		 SUPPL-45 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #018876		 SUPPL-45 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #018876		 SUPPL-45 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/05/2013 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #018876		 SUPPL-45 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/05/2013 ETHAMOLIN
NDA #019357		 SUPPL-20 ETHANOLAMINE OLEATE QOL MEDCL Manufacturing (CMC) Approval
09/05/2013 IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019513		 SUPPL-45 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS OTSUKA ICU MEDCL Manufacturing (CMC) Approval
09/05/2013 IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019515		 SUPPL-33 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS HOSPIRA Manufacturing (CMC) Approval
09/05/2013 LIORESAL
NDA #020075		 SUPPL-27 BACLOFEN AMNEAL Manufacturing (CMC) Approval
09/05/2013 NIZORAL ANTI-DANDRUFF
NDA #020310		 SUPPL-20 KETOCONAZOLE KRAMER Manufacturing (CMC) Approval
09/05/2013 COPAXONE
NDA #020622		 SUPPL-83 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
09/05/2013 COPAXONE
NDA #020622		 SUPPL-85 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
09/05/2013 OXALIPLATIN
ANDA #078811		 SUPPL-5 OXALIPLATIN FRESENIUS KABI USA Labeling Approval
09/05/2013 NARATRIPTAN
ANDA #200502		 SUPPL-1 NARATRIPTAN HYDROCHLORIDE HERITAGE Labeling Approval
09/05/2013 GEMCITABINE HYDROCHLORIDE
NDA #200795		 SUPPL-4 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Labeling Approval
09/05/2013 JENTADUETO
NDA #201281		 SUPPL-4 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
09/06/2013 DILANTIN-125
NDA #008762		 SUPPL-49 PHENYTOIN VIATRIS Manufacturing (CMC) Approval
09/06/2013 DILANTIN-30
NDA #008762		 SUPPL-49 PHENYTOIN VIATRIS Manufacturing (CMC) Approval
09/06/2013 MACRODANTIN
NDA #016620		 SUPPL-72 NITROFURANTOIN, MACROCRYSTALLINE ALMATICA Labeling Approval
09/06/2013 MAGNEVIST
NDA #019596		 SUPPL-55 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Manufacturing (CMC) Approval
09/06/2013 MACROBID
NDA #020064		 SUPPL-21 NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE ALMATICA Labeling Approval
09/06/2013 LOVENOX
NDA #020164		 SUPPL-98 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
09/06/2013 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-98 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
09/06/2013 HUMALOG
BLA #020563		 SUPPL-133 INSULIN LISPRO RECOMBINANT LILLY Approval
09/06/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-133 INSULIN LISPRO RECOMBINANT LILLY Approval
09/06/2013 HUMALOG PEN
BLA #020563		 SUPPL-133 INSULIN LISPRO RECOMBINANT LILLY Approval
09/06/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-133 INSULIN LISPRO RECOMBINANT LILLY Approval
09/06/2013 ARICEPT
NDA #020690		 SUPPL-37 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
09/06/2013 ADRENACLICK
NDA #020800		 SUPPL-23 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
09/06/2013 TWINJECT
NDA #020800		 SUPPL-23 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
09/06/2013 PRILOSEC OTC
NDA #021229		 SUPPL-25 OMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
09/06/2013 APIDRA
BLA #021629		 SUPPL-28 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
09/06/2013 APIDRA SOLOSTAR
BLA #021629		 SUPPL-28 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
09/06/2013 NASCOBAL
NDA #021642		 SUPPL-21 CYANOCOBALAMIN ENDO OPERATIONS Manufacturing (CMC) Approval
09/06/2013 ABRAXANE
NDA #021660		 SUPPL-37 PACLITAXEL BRISTOL-MYERS Efficacy Approval
09/06/2013 ARICEPT ODT
NDA #021720		 SUPPL-10 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
09/06/2013 POTIGA
NDA #022345		 SUPPL-6 EZOGABINE GLAXOSMITHKLINE Labeling Approval
09/06/2013 ARICEPT
NDA #022568		 SUPPL-7 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
09/06/2013 ZOSYN
NDA #050684		 SUPPL-63 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Labeling Approval
09/06/2013 ZOSYN
NDA #050684		 SUPPL-74 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Labeling Approval
09/06/2013 ZOSYN
NDA #050684		 SUPPL-80 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Labeling Approval
09/06/2013 ZOSYN IN PLASTIC CONTAINER
NDA #050750		 SUPPL-21 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM BAXTER HLTHCARE CORP Labeling Approval
09/06/2013 ZOSYN IN PLASTIC CONTAINER
NDA #050750		 SUPPL-26 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM BAXTER HLTHCARE CORP Labeling Approval
09/06/2013 ZOSYN IN PLASTIC CONTAINER
NDA #050750		 SUPPL-30 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM BAXTER HLTHCARE CORP Labeling Approval
09/06/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076113		 SUPPL-24 HYDROCHLOROTHIAZIDE; LISINOPRIL PHARMOBEDIENT Labeling Approval
09/06/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076113		 SUPPL-25 HYDROCHLOROTHIAZIDE; LISINOPRIL PHARMOBEDIENT Labeling Approval
09/06/2013 NITROUS OXIDE, USP
NDA #206014		 ORIG-1 NITROUS OXIDE NITROUS OXIDE OF CANADA Medical Gas Approval
09/07/2013 OXYGEN, USP
NDA #206023		 ORIG-1 OXYGEN AIRGAS USA LLC Medical Gas Approval
09/07/2013 NITROGEN, NF
NDA #206024		 ORIG-1 NITROGEN AIRGAS USA LLC Medical Gas Approval
09/07/2013 CARBON DIOXIDE, USP
NDA #206025		 ORIG-1 CARBON DIOXIDE AIRGAS USA LLC Medical Gas Approval
09/07/2013 HELIUM, USP
NDA #206026		 ORIG-1 HELIUM AIR LIQUIDE HEALTHCARE AMERICA CORP Medical Gas Approval
09/09/2013 RYTHMOL SR
NDA #021416		 SUPPL-12 PROPAFENONE HYDROCHLORIDE GLAXOSMITHKLINE LLC Manufacturing (CMC) Approval
09/09/2013 FORTESTA
NDA #021463		 SUPPL-9 TESTOSTERONE ENDO OPERATIONS Manufacturing (CMC) Approval
09/09/2013 ORAVERSE
NDA #022159		 SUPPL-6 PHENTOLAMINE MESYLATE SEPTODONT HOLDING Manufacturing (CMC) Approval
09/09/2013 GRALISE
NDA #022544		 SUPPL-21 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
09/09/2013 BIAXIN
NDA #050662		 SUPPL-52 CLARITHROMYCIN ABBVIE Labeling Approval
09/09/2013 BIAXIN
NDA #050662		 SUPPL-53 CLARITHROMYCIN ABBVIE Labeling Approval
09/09/2013 BIAXIN
NDA #050698		 SUPPL-31 CLARITHROMYCIN ABBVIE Labeling Approval
09/09/2013 BIAXIN
NDA #050698		 SUPPL-32 CLARITHROMYCIN ABBVIE Labeling Approval
09/09/2013 BIAXIN XL
NDA #050775		 SUPPL-20 CLARITHROMYCIN ABBVIE Labeling Approval
09/09/2013 BIAXIN XL
NDA #050775		 SUPPL-21 CLARITHROMYCIN ABBVIE Labeling Approval
09/09/2013 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #077829		 SUPPL-1 CETIRIZINE HYDROCHLORIDE UNIQUE Manufacturing (CMC) Approval
09/09/2013 CETIRIZINE HYDROCHLORIDE HIVES
ANDA #077829		 SUPPL-1 CETIRIZINE HYDROCHLORIDE UNIQUE Manufacturing (CMC) Approval
09/09/2013 ZOLPIDEM TARTRATE
ANDA #078055		 SUPPL-4 ZOLPIDEM TARTRATE SUN PHARM INDS LTD Labeling Approval
09/09/2013 LEVETIRACETAM
ANDA #203059		 ORIG-1 LEVETIRACETAM SUN PHARM Approval
09/09/2013 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #204226		 ORIG-1 CETIRIZINE HYDROCHLORIDE PERRIGO R AND D Approval
09/10/2013 DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016678		 SUPPL-105 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016683		 SUPPL-100 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #016687		 SUPPL-102 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #016689		 SUPPL-105 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016696		 SUPPL-97 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016697		 SUPPL-96 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
NDA #018037		 SUPPL-70 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-27 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-27 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-27 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-27 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-27 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/10/2013 PREPIDIL
NDA #019617		 SUPPL-16 DINOPROSTONE PFIZER Manufacturing (CMC) Approval
09/10/2013 DEPO-PROVERA
NDA #020246		 SUPPL-49 MEDROXYPROGESTERONE ACETATE PFIZER Manufacturing (CMC) Approval
09/10/2013 LAMISIL
NDA #020980		 SUPPL-10 TERBINAFINE HYDROCHLORIDE KARO HLTHCARE Manufacturing (CMC) Approval
09/10/2013 AVODART
NDA #021319		 SUPPL-30 DUTASTERIDE WAYLIS THERAP Manufacturing (CMC) Approval
09/10/2013 XOPENEX HFA
NDA #021730		 SUPPL-33 LEVALBUTEROL TARTRATE LUPIN Labeling Approval
09/10/2013 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-17 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
09/10/2013 CLARITIN
NDA #021891		 SUPPL-17 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
09/10/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194		 SUPPL-31 HYDROCHLOROTHIAZIDE; LISINOPRIL WATSON LABS Labeling Approval
09/10/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194		 SUPPL-32 HYDROCHLOROTHIAZIDE; LISINOPRIL WATSON LABS Labeling Approval
09/10/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194		 SUPPL-33 HYDROCHLOROTHIAZIDE; LISINOPRIL WATSON LABS Labeling Approval
09/10/2013 NIACIN
ANDA #076250		 SUPPL-8 NIACIN BARR Manufacturing (CMC) Approval
09/10/2013 ZOLPIDEM TARTRATE
ANDA #200266		 ORIG-1 ZOLPIDEM TARTRATE APOTEX Approval
09/10/2013 VARENICLINE
ANDA #201920		 ORIG-1 VARENICLINE TEVA PHARMS USA Tentative Approval
09/11/2013 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016677		 SUPPL-147 SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/11/2013 RINGER'S IN PLASTIC CONTAINER
NDA #016693		 SUPPL-96 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/11/2013 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
NDA #017378		 SUPPL-68 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Labeling Approval
09/11/2013 PLASMA-LYTE A IN PLASTIC CONTAINER
NDA #017378		 SUPPL-68 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Labeling Approval
09/11/2013 PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017385		 SUPPL-59 DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/11/2013 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018016		 SUPPL-61 SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
09/11/2013 DENAVIR
NDA #020629		 SUPPL-16 PENCICLOVIR MYLAN Labeling Approval
09/11/2013 URSO 250
NDA #020675		 SUPPL-25 URSODIOL ABBVIE Manufacturing (CMC) Approval
09/11/2013 URSO FORTE
NDA #020675		 SUPPL-25 URSODIOL ABBVIE Manufacturing (CMC) Approval
09/11/2013 PEPCID AC
NDA #020801		 SUPPL-17 FAMOTIDINE KENVUE BRANDS Manufacturing (CMC) Approval
09/11/2013 ZIAGEN
NDA #020977		 SUPPL-26 ABACAVIR SULFATE VIIV HLTHCARE Labeling Approval
09/11/2013 ZIAGEN
NDA #020978		 SUPPL-30 ABACAVIR SULFATE VIIV HLTHCARE Labeling Approval
09/11/2013 FORTESTA
NDA #021463		 SUPPL-10 TESTOSTERONE ENDO OPERATIONS REMS Approval
09/11/2013 LOVAZA
NDA #021654		 SUPPL-39 OMEGA-3-ACID ETHYL ESTERS WAYLIS THERAP Manufacturing (CMC) Approval
09/11/2013 JANUMET
NDA #022044		 SUPPL-29 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
09/11/2013 VIBRAMYCIN
NDA #050442		 SUPPL-16 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
09/11/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-17 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
09/11/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-18 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
09/11/2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-20 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
09/11/2013 NIACIN
ANDA #076378		 SUPPL-11 NIACIN BARR Manufacturing (CMC) Approval
09/11/2013 TOPIRAMATE
ANDA #078410		 ORIG-1 TOPIRAMATE CHARTWELL Approval
09/11/2013 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-9 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
09/11/2013 ZOLPIDEM TARTRATE
ANDA #078970		 ORIG-1 ZOLPIDEM TARTRATE LUPIN Approval
09/11/2013 BOTOX
BLA #103000		 SUPPL-5260 OnabotulinumtoxinA ALLERGAN Approval
09/11/2013 BOTOX COSMETIC
BLA #103000		 SUPPL-5260 OnabotulinumtoxinA ALLERGAN Approval
09/11/2013 JEVTANA KIT
NDA #201023		 SUPPL-9 CABAZITAXEL SANOFI AVENTIS US Manufacturing (CMC) Approval
09/11/2013 METFORMIN HYDROCHLORIDE
ANDA #203769		 ORIG-1 METFORMIN HYDROCHLORIDE SCIEGEN PHARMS Approval
09/12/2013 UNISOM
NDA #018066		 SUPPL-20 DOXYLAMINE SUCCINATE CHATTEM Labeling Approval
09/12/2013 NORVASC
NDA #019787		 SUPPL-56 AMLODIPINE BESYLATE VIATRIS Manufacturing (CMC) Approval
09/12/2013 ESTROSTEP 21
NDA #020130		 SUPPL-12 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
09/12/2013 ESTROSTEP FE
NDA #020130		 SUPPL-12 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
09/12/2013 VISIPAQUE 270
NDA #020351		 SUPPL-40 IODIXANOL GE HEALTHCARE Manufacturing (CMC) Approval
09/12/2013 VISIPAQUE 320
NDA #020351		 SUPPL-40 IODIXANOL GE HEALTHCARE Manufacturing (CMC) Approval
09/12/2013 CASODEX
NDA #020498		 SUPPL-24 BICALUTAMIDE ANI PHARMS Manufacturing (CMC) Approval
09/12/2013 PATADAY TWICE DAILY RELIEF
NDA #020688		 SUPPL-25 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Manufacturing (CMC) Approval
09/12/2013 PLAVIX
NDA #020839		 SUPPL-57 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Labeling Approval
09/12/2013 PHOSLO
NDA #021160		 SUPPL-26 CALCIUM ACETATE FRESENIUS MEDCL CARE Manufacturing (CMC) Approval
09/12/2013 PHOSLO GELCAPS
NDA #021160		 SUPPL-26 CALCIUM ACETATE FRESENIUS MEDCL CARE Manufacturing (CMC) Approval
09/12/2013 ARIXTRA
NDA #021345		 SUPPL-30 FONDAPARINUX SODIUM MYLAN IRELAND LTD Labeling Approval
09/12/2013 ALIMTA
NDA #021462		 SUPPL-45 PEMETREXED DISODIUM LILLY Labeling Approval
09/12/2013 MOVIPREP
NDA #021881		 SUPPL-15 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE SALIX PHARMS Labeling Approval
09/12/2013 RASAGILINE MESYLATE
ANDA #201950		 ORIG-1 RASAGILINE MESYLATE APOTEX INC Approval
09/12/2013 VINORELBINE TARTRATE
ANDA #202017		 ORIG-1 VINORELBINE TARTRATE DR REDDYS Approval
09/12/2013 ZYTIGA
NDA #202379		 SUPPL-7 ABIRATERONE ACETATE JANSSEN BIOTECH Labeling Approval
09/13/2013 DIFLUCAN
NDA #019949		 SUPPL-57 FLUCONAZOLE PFIZER Labeling Approval
09/13/2013 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-61 FLUCONAZOLE PFIZER Labeling Approval
09/13/2013 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-61 FLUCONAZOLE PFIZER Labeling Approval
09/13/2013 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-61 FLUCONAZOLE PFIZER Labeling Approval
09/13/2013 DIFLUCAN
NDA #020090		 SUPPL-40 FLUCONAZOLE PFIZER Labeling Approval
09/13/2013 FEMHRT
NDA #021065		 SUPPL-21 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
09/13/2013 KEPPRA
NDA #021505		 SUPPL-32 LEVETIRACETAM UCB INC Manufacturing (CMC) Approval
09/13/2013 OMEPRAZOLE
NDA #022032		 SUPPL-22 OMEPRAZOLE DEXCEL PHARMA Manufacturing (CMC) Approval
09/13/2013 TREANDA
NDA #022249		 SUPPL-15 BENDAMUSTINE HYDROCHLORIDE CEPHALON Manufacturing (CMC) Approval
09/13/2013 ISTODAX
NDA #022393		 SUPPL-12 ROMIDEPSIN BRISTOL-MYERS Manufacturing (CMC) Approval
09/13/2013 LANSOPRAZOLE
ANDA #091509		 ORIG-1 LANSOPRAZOLE SUN PHARM Approval
09/13/2013 ABACAVIR SULFATE
ANDA #091560		 ORIG-1 ABACAVIR SULFATE HETERO LABS LTD III Approval
09/13/2013 NEUPOGEN
BLA #103353		 SUPPL-5157 FILGRASTIM AMGEN Approval
09/13/2013 NORETHINDRONE
ANDA #200961		 ORIG-1 NORETHINDRONE NOVAST LABS Approval
09/13/2013 NORETHINDRONE
ANDA #202014		 ORIG-1 NORETHINDRONE NOVAST LABS Approval
09/13/2013 XALKORI
NDA #202570		 SUPPL-8 CRIZOTINIB PF PRISM CV Manufacturing (CMC) Approval
09/13/2013 LANSOPRAZOLE
ANDA #202637		 ORIG-1 LANSOPRAZOLE SUN PHARM Approval
09/13/2013 STIVARGA
NDA #203085		 SUPPL-3 REGORAFENIB BAYER HLTHCARE Manufacturing (CMC) Approval
09/13/2013 SKYLA
NDA #203159		 SUPPL-2 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
09/16/2013 EPI E Z PEN JR
NDA #019430		 SUPPL-55 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
09/16/2013 EPIPEN
NDA #019430		 SUPPL-55 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
09/16/2013 EPIPEN E Z PEN
NDA #019430		 SUPPL-55 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
09/16/2013 EPIPEN JR.
NDA #019430		 SUPPL-55 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
09/16/2013 ANZEMET
NDA #020623		 SUPPL-10 DOLASETRON MESYLATE VALIDUS PHARMS Labeling Approval
09/16/2013 ANZEMET
NDA #020624		 SUPPL-23 DOLASETRON MESYLATE VALIDUS PHARMS Labeling Approval
09/16/2013 AVANDIA
NDA #021071		 SUPPL-45 ROSIGLITAZONE MALEATE WOODWARD REMS Approval
09/16/2013 AVANDAMET
NDA #021410		 SUPPL-34 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE SB PHARMCO REMS Approval
09/16/2013 ZOMIG
NDA #021450		 SUPPL-7 ZOLMITRIPTAN AMNEAL Efficacy Approval
09/16/2013 RIOMET
NDA #021591		 SUPPL-6 METFORMIN HYDROCHLORIDE RANBAXY Manufacturing (CMC) Approval
09/16/2013 AVANDARYL
NDA #021700		 SUPPL-16 GLIMEPIRIDE; ROSIGLITAZONE MALEATE SB PHARMCO REMS Approval
09/16/2013 LANSOPRAZOLE
ANDA #091212		 ORIG-1 LANSOPRAZOLE KRKA TOVARNA ZDRAVIL Approval
09/16/2013 CAPECITABINE
ANDA #091649		 ORIG-1 CAPECITABINE TEVA PHARMS USA Approval
09/16/2013 SUMATRIPTAN SUCCINATE
ANDA #200183		 ORIG-1 SUMATRIPTAN SUCCINATE HIKMA Approval
09/16/2013 AZACITIDINE
ANDA #201537		 ORIG-1 AZACITIDINE DR REDDYS Approval
09/16/2013 INLYTA
NDA #202324		 SUPPL-1 AXITINIB PF PRISM CV Labeling Approval
09/16/2013 CYCLOPHOSPHAMIDE
NDA #203856		 ORIG-1 CYCLOPHOSPHAMIDE HIKMA Type 5 - New Formulation or New Manufacturer Approval
09/17/2013 NUTROPIN AQ
BLA #020522		 SUPPL-50 SOMATROPIN GENENTECH Approval
09/17/2013 NUTROPIN AQ NUSPIN
BLA #020522		 SUPPL-50 SOMATROPIN GENENTECH Approval
09/17/2013 NUTROPIN AQ PEN
BLA #020522		 SUPPL-50 SOMATROPIN GENENTECH Approval
09/17/2013 OPANA
NDA #021611		 SUPPL-8 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Manufacturing (CMC) Approval
09/17/2013 RECLAST
NDA #021817		 SUPPL-17 ZOLEDRONIC ACID SANDOZ Manufacturing (CMC) Approval
09/17/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202046		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE MICRO LABS LTD INDIA Approval
09/18/2013 BICNU
NDA #017422		 SUPPL-45 CARMUSTINE AVET LIFESCIENCES Manufacturing (CMC) Approval
09/18/2013 ZOLPIDEM TARTRATE
ANDA #077214		 SUPPL-5 ZOLPIDEM TARTRATE ACME LABS Labeling Approval
09/18/2013 ZIPRASIDONE HYDROCHLORIDE
ANDA #077561		 SUPPL-2 ZIPRASIDONE HYDROCHLORIDE APOTEX Labeling Approval
09/18/2013 VICTRELIS
NDA #202258		 SUPPL-9 BOCEPREVIR MERCK SHARP DOHME Labeling Approval
09/18/2013 GANCICLOVIR SODIUM
ANDA #202624		 ORIG-1 GANCICLOVIR SODIUM AM REGENT Approval
09/18/2013 SUPRAX
NDA #203195		 SUPPL-2 CEFIXIME LUPIN LTD Manufacturing (CMC) Approval
09/19/2013 METHADONE HYDROCHLORIDE
NDA #017058		 SUPPL-21 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
09/19/2013 COMBIPATCH
NDA #020870		 SUPPL-17 ESTRADIOL; NORETHINDRONE ACETATE NOVEN PHARMS INC Labeling Approval
09/19/2013 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #073135		 SUPPL-19 METOCLOPRAMIDE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
09/19/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076780		 SUPPL-14 ONDANSETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
09/19/2013 ONDANSETRON HYDROCHLORIDE
ANDA #076781		 SUPPL-10 ONDANSETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
09/19/2013 NICOTINE POLACRILEX
ANDA #076880		 SUPPL-3 NICOTINE POLACRILEX IVAX SUB TEVA PHARMS Labeling Approval
09/19/2013 ONDANSETRON HYDROCHLORIDE
ANDA #076930		 SUPPL-6 ONDANSETRON HYDROCHLORIDE RISING Labeling Approval
09/19/2013 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565		 SUPPL-4 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
09/19/2013 NICOTINE POLACRILEX
ANDA #077850		 SUPPL-3 NICOTINE POLACRILEX IVAX SUB TEVA PHARMS Labeling Approval
09/19/2013 ALPRAZOLAM
ANDA #090871		 SUPPL-6 ALPRAZOLAM AUROBINDO PHARMA Labeling Approval
09/19/2013 METHYLPHENIDATE HYDROCHLORIDE
ANDA #091601		 SUPPL-1 METHYLPHENIDATE HYDROCHLORIDE TRIS PHARMA INC Labeling Approval
09/19/2013 HUMIRA
BLA #125057		 SUPPL-327 ADALIMUMAB ABBVIE INC Approval
09/20/2013 8-MOP
NDA #009048		 SUPPL-46 METHOXSALEN VALEANT PHARM INTL Labeling Approval
09/20/2013 OXSORALEN
NDA #009048		 SUPPL-46 METHOXSALEN VALEANT PHARM INTL Labeling Approval
09/20/2013 METOPIRONE
NDA #012911		 SUPPL-32 METYRAPONE ESTEVE Manufacturing (CMC) Approval
09/20/2013 GONAL-F
BLA #020378		 SUPPL-62 FOLLITROPIN ALFA/BETA EMD SERONO Approval
09/20/2013 XOPENEX
NDA #020837		 SUPPL-38 LEVALBUTEROL HYDROCHLORIDE HIKMA Labeling Approval
09/20/2013 CAMPRAL
NDA #021431		 SUPPL-16 ACAMPROSATE CALCIUM FOREST LABS Manufacturing (CMC) Approval
09/20/2013 ENABLEX
NDA #021513		 SUPPL-13 DARIFENACIN HYDROBROMIDE ABBVIE Manufacturing (CMC) Approval
09/20/2013 BYSTOLIC
NDA #021742		 SUPPL-17 NEBIVOLOL HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
09/20/2013 GLIPIZIDE
ANDA #076159		 ORIG-1 GLIPIZIDE PH HEALTH Approval
09/20/2013 DONEPEZIL HYDROCHLORIDE
ANDA #078662		 SUPPL-1 DONEPEZIL HYDROCHLORIDE STRIDES PHARMA Labeling Approval
09/20/2013 DONEPEZIL HYDROCHLORIDE
ANDA #078841		 SUPPL-1 DONEPEZIL HYDROCHLORIDE APOTEX Labeling Approval
09/20/2013 DONEPEZIL HYDROCHLORIDE
ANDA #078841		 SUPPL-2 DONEPEZIL HYDROCHLORIDE APOTEX Labeling Approval
09/20/2013 NITROGLYCERIN
ANDA #091496		 ORIG-1 NITROGLYCERIN PADAGIS ISRAEL Approval
09/20/2013 STELARA
BLA #125261		 SUPPL-103 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
09/20/2013 EPROSARTAN MESYLATE
ANDA #202012		 SUPPL-1 EPROSARTAN MESYLATE PHARMOBEDIENT Labeling Approval
09/20/2013 DESOXIMETASONE
ANDA #202838		 ORIG-1 DESOXIMETASONE GLENMARK PHARMS LTD Approval
09/23/2013 GOLYTELY
NDA #019011		 SUPPL-25 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS AZURITY Labeling Approval
09/23/2013 NULYTELY
NDA #019797		 SUPPL-22 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE AZURITY Labeling Approval
09/23/2013 NULYTELY-FLAVORED
NDA #019797		 SUPPL-22 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE AZURITY Labeling Approval
09/23/2013 DURAGESIC-100
NDA #019813		 SUPPL-60 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
09/23/2013 DURAGESIC-12
NDA #019813		 SUPPL-60 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
09/23/2013 DURAGESIC-25
NDA #019813		 SUPPL-60 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
09/23/2013 DURAGESIC-37
NDA #019813		 SUPPL-60 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
09/23/2013 DURAGESIC-50
NDA #019813		 SUPPL-60 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
09/23/2013 DURAGESIC-75
NDA #019813		 SUPPL-60 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
09/23/2013 ACCUPRIL
NDA #019885		 SUPPL-38 QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
09/23/2013 ALTACE
NDA #019901		 SUPPL-60 RAMIPRIL KING PHARMS LLC Labeling Approval
09/23/2013 SUPRANE
NDA #020118		 SUPPL-18 DESFLURANE BAXTER HLTHCARE Labeling Approval
09/23/2013 ACCURETIC
NDA #020125		 SUPPL-15 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
09/23/2013 HECTOROL
NDA #021027		 SUPPL-27 DOXERCALCIFEROL SANOFI Manufacturing (CMC) Approval
09/23/2013 METHYLPHENIDATE HYDROCHLORIDE
ANDA #091695		 ORIG-2 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Approval
09/23/2013 ZOLEDRONIC ACID
ANDA #202828		 ORIG-1 ZOLEDRONIC ACID INFORLIFE Approval
09/24/2013 PERCODAN
NDA #007337		 SUPPL-47 ASPIRIN; OXYCODONE HYDROCHLORIDE ENDO OPERATIONS Manufacturing (CMC) Approval
09/24/2013 PERCODAN
NDA #007337		 SUPPL-47 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ENDO OPERATIONS Manufacturing (CMC) Approval
09/24/2013 PERCODAN-DEMI
NDA #007337		 SUPPL-47 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ENDO OPERATIONS Manufacturing (CMC) Approval
09/24/2013 XYLOCAINE
NDA #008816		 SUPPL-37 LIDOCAINE HYDROCHLORIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
09/24/2013 HEPARIN SODIUM
NDA #017029		 SUPPL-136 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
09/24/2013 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-136 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
09/24/2013 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-136 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
09/24/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #017029		 SUPPL-136 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
09/24/2013 HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029		 SUPPL-136 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
09/24/2013 HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029		 SUPPL-136 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
09/24/2013 QSYMIA
NDA #022580		 SUPPL-8 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Manufacturing (CMC) Approval
09/24/2013 ACEPHEN
ANDA #072237		 SUPPL-9 ACETAMINOPHEN COSETTE PHARMS NC Labeling Approval
09/24/2013 RITUXAN
BLA #103705		 SUPPL-5414 RITUXIMAB GENENTECH Approval
09/24/2013 ARZERRA
BLA #125326		 SUPPL-59 OFATUMUMAB NOVARTIS Approval
09/24/2013 KESIMPTA
BLA #125326		 SUPPL-59 OFATUMUMAB NOVARTIS Approval
09/24/2013 SODIUM CHLORIDE 0.9%
ANDA #201833		 ORIG-1 SODIUM CHLORIDE HIKMA Approval
09/25/2013 REBETOL
NDA #021546		 SUPPL-5 RIBAVIRIN SCHERING Manufacturing (CMC) Approval
09/25/2013 VIMPAT
NDA #022253		 SUPPL-14 LACOSAMIDE UCB INC Labeling Approval
09/25/2013 VIMPAT
NDA #022253		 SUPPL-16 LACOSAMIDE UCB INC Labeling Approval
09/25/2013 VIMPAT
NDA #022254		 SUPPL-8 LACOSAMIDE UCB INC Labeling Approval
09/25/2013 VIMPAT
NDA #022254		 SUPPL-9 LACOSAMIDE UCB INC Labeling Approval
09/25/2013 VIMPAT
NDA #022255		 SUPPL-3 LACOSAMIDE UCB INC Labeling Approval
09/25/2013 VIMPAT
NDA #022255		 SUPPL-5 LACOSAMIDE UCB INC Labeling Approval
09/25/2013 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040422		 SUPPL-30 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BARR Labeling Approval
09/25/2013 FOSPHENYTOIN SODIUM
ANDA #077989		 SUPPL-1 FOSPHENYTOIN SODIUM HIKMA Labeling Approval
09/26/2013 MESTINON
NDA #015193		 SUPPL-24 PYRIDOSTIGMINE BROMIDE BAUSCH Manufacturing (CMC) Approval
09/26/2013 TERAZOL 7
NDA #019579		 SUPPL-35 TERCONAZOLE JANSSEN PHARMS Labeling Approval
09/26/2013 TERAZOL 3
NDA #019641		 SUPPL-28 TERCONAZOLE JANSSEN PHARMS Labeling Approval
09/26/2013 ZOLOFT
NDA #019839		 SUPPL-82 SERTRALINE HYDROCHLORIDE VIATRIS Manufacturing (CMC) Approval
09/26/2013 TERAZOL 3
NDA #019964		 SUPPL-30 TERCONAZOLE JANSSEN PHARMS Labeling Approval
09/26/2013 SOMAVERT
BLA #021106		 SUPPL-42 PEGVISOMANT PHARMACIA Approval
09/26/2013 REMODULIN
NDA #021272		 SUPPL-20 TREPROSTINIL UNITED THERAP Labeling Approval
09/26/2013 TYGACIL
NDA #021821		 SUPPL-26 TIGECYCLINE PF PRISM CV Labeling Approval
09/26/2013 TYGACIL
NDA #021821		 SUPPL-31 TIGECYCLINE PF PRISM CV Labeling Approval
09/26/2013 PUR-WASH
NDA #022305		 SUPPL-1 PURIFIED WATER NIAGARA PHARMS Manufacturing (CMC) Approval
09/26/2013 TOBI
NDA #050753		 SUPPL-11 TOBRAMYCIN VIATRIS Labeling Approval
09/26/2013 RIBAVIRIN
ANDA #076277		 SUPPL-8 RIBAVIRIN TEVA Labeling Approval
09/26/2013 RIBAVIRIN
ANDA #076277		 SUPPL-9 RIBAVIRIN TEVA Labeling Approval
09/26/2013 VYFEMLA
ANDA #201886		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN Approval
09/27/2013 SOLU-CORTEF
NDA #009866		 SUPPL-97 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
09/27/2013 MAXIDEX
NDA #013422		 SUPPL-40 DEXAMETHASONE HARROW EYE Manufacturing (CMC) Approval
09/27/2013 CARDENE
NDA #019734		 SUPPL-21 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
09/27/2013 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-21 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
09/27/2013 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-21 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
09/27/2013 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-21 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
09/27/2013 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-21 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
09/27/2013 SUPRANE
NDA #020118		 SUPPL-19 DESFLURANE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/27/2013 LOVENOX
NDA #020164		 SUPPL-103 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
09/27/2013 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-103 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
09/27/2013 DEPO-PROVERA
NDA #020246		 SUPPL-50 MEDROXYPROGESTERONE ACETATE PFIZER Manufacturing (CMC) Approval
09/27/2013 FRAGMIN
NDA #020287		 SUPPL-59 DALTEPARIN SODIUM PFIZER Manufacturing (CMC) Approval
09/27/2013 IMODIUM A-D EZ CHEWS
NDA #020448		 SUPPL-7 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
09/27/2013 GLUCAGON
NDA #020928		 SUPPL-47 GLUCAGON LILLY Manufacturing (CMC) Approval
09/27/2013 FROVA
NDA #021006		 SUPPL-20 FROVATRIPTAN SUCCINATE ENDO OPERATIONS Manufacturing (CMC) Approval
09/27/2013 ZOMETA
NDA #021223		 SUPPL-27 ZOLEDRONIC ACID NOVARTIS Labeling Approval
09/27/2013 IMPLANON
NDA #021529		 SUPPL-10 ETONOGESTREL ORGANON Labeling Approval
09/27/2013 NEXPLANON
NDA #021529		 SUPPL-10 ETONOGESTREL ORGANON Labeling Approval
09/27/2013 ACTOPLUS MET XR
NDA #022024		 SUPPL-10 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
09/27/2013 TASIGNA
NDA #022068		 SUPPL-18 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
09/27/2013 SAMSCA
NDA #022275		 SUPPL-10 TOLVAPTAN OTSUKA Manufacturing (CMC) Approval
09/27/2013 TIMENTIN
NDA #050590		 SUPPL-67 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Labeling Approval
09/27/2013 TIMENTIN IN PLASTIC CONTAINER
NDA #050658		 SUPPL-29 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Labeling Approval
09/27/2013 CELLCEPT
NDA #050722		 SUPPL-30 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
09/27/2013 CELLCEPT
NDA #050722		 SUPPL-31 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
09/27/2013 CELLCEPT
NDA #050723		 SUPPL-29 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
09/27/2013 CELLCEPT
NDA #050723		 SUPPL-30 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
09/27/2013 CELLCEPT
NDA #050758		 SUPPL-28 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Labeling Approval
09/27/2013 CELLCEPT
NDA #050758		 SUPPL-29 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO REMS Approval
09/27/2013 CELLCEPT
NDA #050759		 SUPPL-36 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
09/27/2013 CELLCEPT
NDA #050759		 SUPPL-37 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
09/27/2013 MYFORTIC
NDA #050791		 SUPPL-18 MYCOPHENOLATE SODIUM NOVARTIS Labeling Approval
09/27/2013 MYFORTIC
NDA #050791		 SUPPL-19 MYCOPHENOLATE SODIUM NOVARTIS REMS Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065379		 SUPPL-17 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065410		 SUPPL-8 MYCOPHENOLATE MOFETIL HIKMA REMS Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065413		 SUPPL-9 MYCOPHENOLATE MOFETIL HIKMA Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065416		 SUPPL-9 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065451		 SUPPL-16 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065457		 SUPPL-6 MYCOPHENOLATE MOFETIL TEVA PHARMS Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065491		 SUPPL-8 MYCOPHENOLATE MOFETIL TEVA PHARMS Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065520		 SUPPL-13 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #065521		 SUPPL-10 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
09/27/2013 TRAMADOL HYDROCHLORIDE
ANDA #076003		 SUPPL-18 TRAMADOL HYDROCHLORIDE AMNEAL PHARMS Manufacturing (CMC) Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #090055		 SUPPL-4 MYCOPHENOLATE MOFETIL STRIDES PHARMA Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #090111		 SUPPL-7 MYCOPHENOLATE MOFETIL STRIDES PHARMA INTL REMS Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #090253		 SUPPL-9 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #090419		 SUPPL-7 MYCOPHENOLATE MOFETIL APOTEX CORP Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #090456		 SUPPL-6 MYCOPHENOLATE MOFETIL STRIDES PHARMA Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #090499		 SUPPL-8 MYCOPHENOLATE MOFETIL APOTEX Labeling Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #090606		 SUPPL-6 MYCOPHENOLATE MOFETIL AMNEAL REMS Approval
09/27/2013 PARICALCITOL
ANDA #090829		 ORIG-1 PARICALCITOL TEVA PHARMS USA Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #091249		 SUPPL-3 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
09/27/2013 CIMZIA
BLA #125160		 SUPPL-213 CERTOLIZUMAB PEGOL UCB INC Approval
09/27/2013 MYCOPHENOLATE MOFETIL
ANDA #200197		 SUPPL-1 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
09/27/2013 HALAVEN
NDA #201532		 SUPPL-7 ERIBULIN MESYLATE EISAI INC Manufacturing (CMC) Approval
09/27/2013 BUDESONIDE
ANDA #201966		 ORIG-1 BUDESONIDE SANDOZ Approval
09/27/2013 HYDROCORTISONE BUTYRATE
ANDA #202145		 ORIG-1 HYDROCORTISONE BUTYRATE GLENMARK PHARMS LTD Approval
09/27/2013 OSPHENA
NDA #203505		 SUPPL-2 OSPEMIFENE DUCHESNAY Manufacturing (CMC) Approval
09/28/2013 PRECEDEX
NDA #021038		 SUPPL-23 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
09/29/2013 GALANTAMINE HYDROBROMIDE
ANDA #090957		 SUPPL-7 GALANTAMINE HYDROBROMIDE AUROBINDO PHARMA LTD Labeling Approval
09/30/2013 ACCUNEB
NDA #020949		 SUPPL-25 ALBUTEROL SULFATE PHARMOBEDIENT Manufacturing (CMC) Approval
09/30/2013 ACCUNEB
NDA #020949		 SUPPL-26 ALBUTEROL SULFATE PHARMOBEDIENT Manufacturing (CMC) Approval
09/30/2013 AEROSPAN HFA
NDA #021247		 SUPPL-9 FLUNISOLIDE PHARMOBEDIENT Manufacturing (CMC) Approval
09/30/2013 DICLEGIS
NDA #021876		 SUPPL-2 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Manufacturing (CMC) Approval
09/30/2013 ADENOSINE
ANDA #077133		 SUPPL-5 ADENOSINE FRESENIUS KABI USA Labeling Approval
09/30/2013 ADENOSINE
ANDA #078076		 SUPPL-2 ADENOSINE RISING Labeling Approval
09/30/2013 SIMVASTATIN
ANDA #078155		 SUPPL-10 SIMVASTATIN ACCORD HLTHCARE Manufacturing (CMC) Approval
09/30/2013 DICLOFENAC SODIUM
ANDA #078792		 SUPPL-6 DICLOFENAC SODIUM BAUSCH AND LOMB Labeling Approval
09/30/2013 ADENOSINE
ANDA #090220		 SUPPL-2 ADENOSINE WOCKHARDT Labeling Approval
09/30/2013 MYCOPHENOLATE SODIUM
ANDA #091558		 SUPPL-2 MYCOPHENOLATE SODIUM APOTEX INC REMS Approval
09/30/2013 PERJETA
BLA #125409		 SUPPL-51 PERTUZUMAB GENENTECH Approval
09/30/2013 CLONIDINE HYDROCHLORIDE
ANDA #202984		 ORIG-1 CLONIDINE HYDROCHLORIDE PH HEALTH Approval
09/30/2013 BOSULIF
NDA #203341		 SUPPL-1 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
09/30/2013 TRINTELLIX
NDA #204447		 ORIG-1 VORTIOXETINE HYDROBROMIDE TAKEDA PHARMS USA Type 1 - New Molecular Entity Approval
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