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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 2015

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

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

This report was produced on December 08, 2023.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2015 ADDERALL 10
NDA #011522		 SUPPL-42 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
10/01/2015 ADDERALL 12.5
NDA #011522		 SUPPL-42 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
10/01/2015 ADDERALL 15
NDA #011522		 SUPPL-42 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
10/01/2015 ADDERALL 20
NDA #011522		 SUPPL-42 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
10/01/2015 ADDERALL 30
NDA #011522		 SUPPL-42 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
10/01/2015 ADDERALL 5
NDA #011522		 SUPPL-42 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
10/01/2015 ADDERALL 7.5
NDA #011522		 SUPPL-42 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
10/01/2015 ELOXATIN
NDA #021492		 SUPPL-14 OXALIPLATIN SANOFI AVENTIS US Labeling Approval
10/01/2015 ELOXATIN
NDA #021759		 SUPPL-19 OXALIPLATIN SANOFI AVENTIS US Labeling Approval
10/01/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #076565		 SUPPL-11 VENLAFAXINE HYDROCHLORIDE TEVA Labeling Approval
10/01/2015 AMLODIPINE BESYLATE
ANDA #076846		 SUPPL-14 AMLODIPINE BESYLATE TEVA Labeling Approval
10/01/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202046		 SUPPL-1 LEVOCETIRIZINE DIHYDROCHLORIDE MICRO LABS LTD INDIA Labeling Approval
10/01/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202046		 SUPPL-2 LEVOCETIRIZINE DIHYDROCHLORIDE MICRO LABS LTD INDIA Labeling Approval
10/01/2015 LAMOTRIGINE
ANDA #202383		 SUPPL-2 LAMOTRIGINE DR REDDYS LABS LTD Tentative Approval
10/01/2015 XTANDI
NDA #203415		 SUPPL-7 ENZALUTAMIDE ASTELLAS Labeling Approval
10/01/2015 RYANODEX
NDA #205579		 SUPPL-1 DANTROLENE SODIUM EAGLE PHARMS Manufacturing (CMC) Approval
10/02/2015 RITALIN
NDA #010187		 SUPPL-81 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
10/02/2015 MACRODANTIN
NDA #016620		 SUPPL-73 NITROFURANTOIN, MACROCRYSTALLINE ALMATICA Manufacturing (CMC) Approval
10/02/2015 PREGNYL
BLA #017692		 SUPPL-27 GONADOTROPIN, CHORIONIC ORGANON USA INC Approval
10/02/2015 ATIVAN
NDA #018140		 SUPPL-39 LORAZEPAM HIKMA Manufacturing (CMC) Approval
10/02/2015 COREG
NDA #020297		 SUPPL-37 CARVEDILOL WOODWARD Labeling Approval
10/02/2015 COPAXONE
NDA #020622		 SUPPL-96 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
10/02/2015 INFUVITE ADULT
NDA #021163		 SUPPL-30 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
10/02/2015 COREG CR
NDA #022012		 SUPPL-21 CARVEDILOL PHOSPHATE WOODWARD Labeling Approval
10/02/2015 LETAIRIS
NDA #022081		 SUPPL-33 AMBRISENTAN GILEAD Efficacy Approval
10/02/2015 IBUPROFEN
ANDA #072249		 SUPPL-3 IBUPROFEN VINTAGE PHARMS Labeling Approval
10/02/2015 NIFEDIPINE
ANDA #074045		 SUPPL-6 NIFEDIPINE LEADING Manufacturing (CMC) Approval
10/02/2015 GLYBURIDE (MICRONIZED)
ANDA #074792		 SUPPL-14 GLYBURIDE MYLAN Labeling Approval
10/02/2015 AMLODIPINE BESYLATE
ANDA #077073		 SUPPL-6 AMLODIPINE BESYLATE CIPLA Labeling Approval
10/02/2015 PREDNICARBATE
ANDA #077287		 SUPPL-3 PREDNICARBATE FOUGERA PHARMS Labeling Approval
10/02/2015 SERTRALINE HYDROCHLORIDE
ANDA #077713		 SUPPL-4 SERTRALINE HYDROCHLORIDE FOSUN PHARMA Labeling Approval
10/02/2015 SERTRALINE HYDROCHLORIDE
ANDA #077713		 SUPPL-5 SERTRALINE HYDROCHLORIDE FOSUN PHARMA Labeling Approval
10/02/2015 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
ANDA #078083		 SUPPL-3 GLIPIZIDE; METFORMIN HYDROCHLORIDE DASH PHARMS Labeling Approval
10/02/2015 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
ANDA #078083		 SUPPL-5 GLIPIZIDE; METFORMIN HYDROCHLORIDE DASH PHARMS Labeling Approval
10/02/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #078789		 SUPPL-6 VENLAFAXINE HYDROCHLORIDE MYLAN Labeling Approval
10/02/2015 LEVETIRACETAM
ANDA #090767		 SUPPL-1 LEVETIRACETAM VKT PHARMA Labeling Approval
10/02/2015 LEVETIRACETAM
ANDA #090767		 SUPPL-3 LEVETIRACETAM VKT PHARMA Labeling Approval
10/02/2015 LEVETIRACETAM
ANDA #090767		 SUPPL-4 LEVETIRACETAM VKT PHARMA Labeling Approval
10/02/2015 LEVETIRACETAM
ANDA #090767		 SUPPL-5 LEVETIRACETAM VKT PHARMA Labeling Approval
10/02/2015 LEVETIRACETAM
ANDA #090767		 SUPPL-6 LEVETIRACETAM VKT PHARMA Labeling Approval
10/02/2015 REMICADE
BLA #103772		 SUPPL-5373 INFLIXIMAB CENTOCOR INC Approval
10/02/2015 KEYTRUDA
BLA #125514		 SUPPL-5 PEMBROLIZUMAB MERCK SHARP DOHME Approval
10/02/2015 TOBI PODHALER
NDA #201688		 SUPPL-6 TOBRAMYCIN MYLAN SPECIALITY LP Labeling Approval
10/02/2015 VASCEPA
NDA #202057		 SUPPL-14 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
10/02/2015 MORPHABOND ER
NDA #206544		 ORIG-1 MORPHINE SULFATE OHEMO LIFE Type 5 - New Formulation or New Manufacturer Approval
10/05/2015 IC-GREEN
NDA #011525		 SUPPL-27 INDOCYANINE GREEN OAK TREE PHARMA Labeling Approval
10/05/2015 GLUCOTROL XL
NDA #020329		 SUPPL-29 GLIPIZIDE PFIZER Labeling Approval
10/05/2015 PHENYTOIN SODIUM
ANDA #040781		 SUPPL-2 PHENYTOIN SODIUM AM REGENT Labeling Approval
10/05/2015 PHENYTOIN SODIUM
ANDA #040781		 SUPPL-4 PHENYTOIN SODIUM AM REGENT Labeling Approval
10/05/2015 PHENYTOIN SODIUM
ANDA #040781		 SUPPL-5 PHENYTOIN SODIUM AM REGENT Labeling Approval
10/05/2015 TOBI
NDA #050753		 SUPPL-18 TOBRAMYCIN MYLAN SPECIALITY LP Labeling Approval
10/05/2015 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-21 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
10/05/2015 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-22 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
10/05/2015 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077742		 SUPPL-9 FLUOXETINE HYDROCHLORIDE; OLANZAPINE PAR PHARM Labeling Approval
10/05/2015 SIMVASTATIN
ANDA #077752		 SUPPL-22 SIMVASTATIN DR REDDYS LABS INC Labeling Approval
10/05/2015 SIMVASTATIN
ANDA #077837		 SUPPL-35 SIMVASTATIN ZYDUS PHARMS USA Labeling Approval
10/05/2015 NARATRIPTAN
ANDA #091326		 SUPPL-3 NARATRIPTAN HYDROCHLORIDE PADAGIS US Labeling Approval
10/05/2015 MYCOPHENOLATE MOFETIL
ANDA #200197		 SUPPL-2 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
10/05/2015 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #201529		 SUPPL-3 METHOTREXATE SODIUM EUGIA PHARMA SPECLTS Labeling Approval
10/05/2015 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #201529		 SUPPL-4 METHOTREXATE SODIUM EUGIA PHARMA SPECLTS Labeling Approval
10/05/2015 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #201530		 SUPPL-3 METHOTREXATE SODIUM MYLAN Labeling Approval
10/05/2015 INDOMETHACIN
ANDA #202706		 ORIG-1 INDOMETHACIN JUBILANT GENERICS Approval
10/05/2015 GATTEX KIT
NDA #203441		 SUPPL-6 TEDUGLUTIDE RECOMBINANT TAKEDA PHARMS USA Manufacturing (CMC) Approval
10/05/2015 OLYSIO
NDA #205123		 SUPPL-5 SIMEPREVIR SODIUM JANSSEN PRODS Efficacy Approval
10/05/2015 OLYSIO
NDA #205123		 SUPPL-6 SIMEPREVIR SODIUM JANSSEN PRODS Efficacy Approval
10/05/2015 ARISTADA
NDA #207533		 ORIG-1 ARIPIPRAZOLE LAUROXIL ALKERMES INC Type 1 - New Molecular Entity Approval
10/06/2015 KENALOG
NDA #012104		 SUPPL-36 TRIAMCINOLONE ACETONIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
10/06/2015 CISPLATIN
NDA #018057		 SUPPL-85 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
10/06/2015 PLATINOL
NDA #018057		 SUPPL-85 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
10/06/2015 PLATINOL-AQ
NDA #018057		 SUPPL-85 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
10/06/2015 BUPHENYL
NDA #020572		 SUPPL-21 SODIUM PHENYLBUTYRATE HORIZON THERAP US Manufacturing (CMC) Approval
10/06/2015 MAXITROL
NDA #050065		 SUPPL-60 DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SANDOZ Manufacturing (CMC) Approval
10/06/2015 CYCLOSPORINE
ANDA #065025		 SUPPL-20 CYCLOSPORINE ABBVIE Labeling Approval
10/06/2015 CYCLOSPORINE
ANDA #065025		 SUPPL-21 CYCLOSPORINE ABBVIE Labeling Approval
10/06/2015 CYCLOSPORINE
ANDA #065025		 SUPPL-23 CYCLOSPORINE ABBVIE Labeling Approval
10/06/2015 COLISTIMETHATE SODIUM
ANDA #065364		 SUPPL-3 COLISTIMETHATE SODIUM FRESENIUS KABI USA Labeling Approval
10/06/2015 CEFPODOXIME PROXETIL
ANDA #065388		 SUPPL-2 CEFPODOXIME PROXETIL ANDA REPOSITORY Labeling Approval
10/06/2015 TIMOLOL MALEATE
ANDA #074746		 SUPPL-12 TIMOLOL MALEATE PACIFIC PHARMA Labeling Approval
10/06/2015 TIMOLOL MALEATE
ANDA #074747		 SUPPL-14 TIMOLOL MALEATE PACIFIC PHARMA Labeling Approval
10/06/2015 BETAXOLOL HYDROCHLORIDE
ANDA #075630		 SUPPL-6 BETAXOLOL HYDROCHLORIDE MEDIMETRIKS PHARMS Labeling Approval
10/06/2015 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-7 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
10/06/2015 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076486		 SUPPL-11 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE NOSTRUM LABS INC Labeling Approval
10/06/2015 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076486		 SUPPL-13 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE NOSTRUM LABS INC Labeling Approval
10/06/2015 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076486		 SUPPL-15 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE NOSTRUM LABS INC Labeling Approval
10/06/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076896		 SUPPL-16 CIPROFLOXACIN HYDROCHLORIDE CHARTWELL Labeling Approval
10/06/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076896		 SUPPL-17 CIPROFLOXACIN HYDROCHLORIDE CHARTWELL Labeling Approval
10/06/2015 GLYBURIDE
ANDA #077537		 SUPPL-11 GLYBURIDE AUROBINDO PHARMA Labeling Approval
10/06/2015 ATORVASTATIN CALCIUM
ANDA #077575		 SUPPL-4 ATORVASTATIN CALCIUM SANDOZ INC Labeling Approval
10/06/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #077859		 SUPPL-18 CIPROFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
10/06/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #077859		 SUPPL-24 CIPROFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
10/06/2015 AMLODIPINE BESYLATE
ANDA #077974		 SUPPL-3 AMLODIPINE BESYLATE SUN PHARM INDS LTD Labeling Approval
10/06/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078385		 SUPPL-14 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
10/06/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #078515		 SUPPL-10 DROSPIRENONE; ETHINYL ESTRADIOL BARR Labeling Approval
10/06/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #078515		 SUPPL-11 DROSPIRENONE; ETHINYL ESTRADIOL BARR Labeling Approval
10/06/2015 AMIODARONE HYDROCHLORIDE
ANDA #079029		 SUPPL-14 AMIODARONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
10/06/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #090408		 SUPPL-7 TAMSULOSIN HYDROCHLORIDE MYLAN Labeling Approval
10/06/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #090408		 SUPPL-10 TAMSULOSIN HYDROCHLORIDE MYLAN Labeling Approval
10/06/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #090408		 SUPPL-11 TAMSULOSIN HYDROCHLORIDE MYLAN Labeling Approval
10/06/2015 MYCOPHENOLATE MOFETIL
ANDA #090419		 SUPPL-8 MYCOPHENOLATE MOFETIL APOTEX CORP Labeling Approval
10/06/2015 MYCOPHENOLATE MOFETIL
ANDA #090419		 SUPPL-10 MYCOPHENOLATE MOFETIL APOTEX CORP Labeling Approval
10/06/2015 MYCOPHENOLATE MOFETIL
ANDA #090499		 SUPPL-9 MYCOPHENOLATE MOFETIL APOTEX Labeling Approval
10/06/2015 MYCOPHENOLATE MOFETIL
ANDA #090499		 SUPPL-11 MYCOPHENOLATE MOFETIL APOTEX Labeling Approval
10/06/2015 ATORVASTATIN CALCIUM
ANDA #090548		 SUPPL-11 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
10/06/2015 FENOFIBRATE
ANDA #090715		 SUPPL-3 FENOFIBRATE VALEANT PHARMS NORTH Labeling Approval
10/06/2015 MYCOPHENOLATE MOFETIL
ANDA #091249		 SUPPL-5 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
10/06/2015 LEVOFLOXACIN
ANDA #200839		 SUPPL-4 LEVOFLOXACIN MACLEODS PHARMS LTD Labeling Approval
10/06/2015 LEVOFLOXACIN
ANDA #200839		 SUPPL-5 LEVOFLOXACIN MACLEODS PHARMS LTD Labeling Approval
10/06/2015 LEVOFLOXACIN
ANDA #200839		 SUPPL-7 LEVOFLOXACIN MACLEODS PHARMS LTD Labeling Approval
10/06/2015 BANZEL
NDA #201367		 SUPPL-6 RUFINAMIDE EISAI INC Manufacturing (CMC) Approval
10/06/2015 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-2 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
10/06/2015 JAKAFI
NDA #202192		 SUPPL-11 RUXOLITINIB PHOSPHATE INCYTE CORP Manufacturing (CMC) Approval
10/06/2015 ATORVASTATIN CALCIUM
ANDA #202357		 SUPPL-6 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
10/06/2015 MARQIBO KIT
NDA #202497		 SUPPL-4 VINCRISTINE SULFATE ACROTECH Manufacturing (CMC) Approval
10/06/2015 PICATO
NDA #202833		 SUPPL-5 INGENOL MEBUTATE LEO LABS Labeling Approval
10/06/2015 ACITRETIN
ANDA #204633		 SUPPL-1 ACITRETIN SIGMAPHARM LABS LLC Labeling Approval
10/06/2015 NAMZARIC
NDA #206439		 SUPPL-2 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
10/07/2015 NICODERM CQ
NDA #020165		 SUPPL-36 NICOTINE CHATTEM SANOFI Labeling Approval
10/07/2015 ZOLINZA
NDA #021991		 SUPPL-7 VORINOSTAT MSD SUB MERCK Manufacturing (CMC) Approval
10/07/2015 ZONISAMIDE
ANDA #077634		 SUPPL-10 ZONISAMIDE SUN PHARM INDS (IN) Labeling Approval
10/07/2015 AMLODIPINE BESYLATE
ANDA #078226		 SUPPL-13 AMLODIPINE BESYLATE ZYDUS PHARMS USA Labeling Approval
10/07/2015 AMLODIPINE BESYLATE
ANDA #078453		 SUPPL-4 AMLODIPINE BESYLATE ORBION PHARMS Labeling Approval
10/07/2015 LOSARTAN POTASSIUM
ANDA #091541		 SUPPL-5 LOSARTAN POTASSIUM MICRO LABS Labeling Approval
10/07/2015 FENOFIBRIC ACID
ANDA #200920		 ORIG-1 CHOLINE FENOFIBRATE ACTAVIS ELIZABETH Approval
10/07/2015 KETOROLAC TROMETHAMINE
ANDA #203242		 ORIG-1 KETOROLAC TROMETHAMINE FRESENIUS KABI USA Approval
10/08/2015 MANNITOL 10%
NDA #016269		 SUPPL-52 MANNITOL HOSPIRA Manufacturing (CMC) Approval
10/08/2015 MANNITOL 15%
NDA #016269		 SUPPL-52 MANNITOL HOSPIRA Manufacturing (CMC) Approval
10/08/2015 MANNITOL 20%
NDA #016269		 SUPPL-52 MANNITOL HOSPIRA Manufacturing (CMC) Approval
10/08/2015 MANNITOL 25%
NDA #016269		 SUPPL-52 MANNITOL HOSPIRA Manufacturing (CMC) Approval
10/08/2015 MANNITOL 5%
NDA #016269		 SUPPL-52 MANNITOL HOSPIRA Manufacturing (CMC) Approval
10/08/2015 HUMULIN R
BLA #018780		 SUPPL-151 INSULIN HUMAN LILLY Approval
10/08/2015 HUMULIN R
BLA #018780		 SUPPL-151 INSULIN RECOMBINANT HUMAN LILLY Approval
10/08/2015 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-151 INSULIN HUMAN LILLY Approval
10/08/2015 HUMULIN R PEN
BLA #018780		 SUPPL-151 INSULIN RECOMBINANT HUMAN LILLY Approval
10/08/2015 HUMULIN N
BLA #018781		 SUPPL-158 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
10/08/2015 CLOZARIL
NDA #019758		 SUPPL-78 CLOZAPINE HERITAGE LIFE Labeling Approval
10/08/2015 TIMOPTIC-XE
NDA #020330		 SUPPL-29 TIMOLOL MALEATE BAUSCH AND LOMB INC Labeling Approval
10/08/2015 GLUCAGEN
NDA #020918		 SUPPL-44 GLUCAGON HYDROCHLORIDE NOVO NORDISK Manufacturing (CMC) Approval
10/08/2015 PATADAY ONCE DAILY RELIEF
NDA #021545		 SUPPL-18 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Manufacturing (CMC) Approval
10/08/2015 SUTENT
NDA #021938		 SUPPL-30 SUNITINIB MALATE CPPI CV Manufacturing (CMC) Approval
10/08/2015 EXPAREL
NDA #022496		 SUPPL-16 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
10/08/2015 CEFAZOLIN AND DEXTROSE
NDA #050779		 SUPPL-25 CEFAZOLIN SODIUM B BRAUN Labeling Approval
10/08/2015 ACANYA
NDA #050819		 SUPPL-15 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
10/08/2015 ONEXTON
NDA #050819		 SUPPL-15 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
10/08/2015 SIMVASTATIN
ANDA #078034		 SUPPL-9 SIMVASTATIN BIOCON PHARMA Labeling Approval
10/08/2015 SIMVASTATIN
ANDA #078103		 SUPPL-33 SIMVASTATIN LUPIN Labeling Approval
10/08/2015 MONTELUKAST SODIUM
ANDA #079103		 SUPPL-9 MONTELUKAST SODIUM MYLAN PHARMS INC Labeling Approval
10/08/2015 MONTELUKAST SODIUM
ANDA #079142		 SUPPL-9 MONTELUKAST SODIUM MYLAN PHARMS INC Labeling Approval
10/08/2015 CICLOPIROX
ANDA #090269		 SUPPL-2 CICLOPIROX TARO Labeling Approval
10/08/2015 LEVOFLOXACIN
ANDA #201043		 SUPPL-7 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/08/2015 LEVOFLOXACIN
ANDA #201043		 SUPPL-9 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/08/2015 TELMISARTAN
ANDA #202130		 SUPPL-2 TELMISARTAN ALEMBIC Labeling Approval
10/08/2015 MONTELUKAST SODIUM
ANDA #202776		 SUPPL-2 MONTELUKAST SODIUM MYLAN PHARMS INC Labeling Approval
10/08/2015 MONTELUKAST SODIUM
ANDA #202776		 SUPPL-5 MONTELUKAST SODIUM MYLAN PHARMS INC Labeling Approval
10/08/2015 ZOLEDRONIC ACID
NDA #203231		 SUPPL-10 ZOLEDRONIC ACID INFORLIFE Labeling Approval
10/08/2015 BOSULIF
NDA #203341		 SUPPL-4 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
10/08/2015 ARIPIPRAZOLE
ANDA #203908		 ORIG-1 ARIPIPRAZOLE AUROBINDO PHARMA Approval
10/08/2015 MONTELUKAST SODIUM
ANDA #204290		 ORIG-1 MONTELUKAST SODIUM UNICHEM Approval
10/09/2015 NOR-QD
NDA #017060		 SUPPL-82 NORETHINDRONE TEVA BRANDED PHARM Manufacturing (CMC) Approval
10/09/2015 INOMAX
NDA #020845		 SUPPL-16 NITRIC OXIDE MALLINCKRODT HOSP Labeling Approval
10/09/2015 INOMAX
NDA #020845		 SUPPL-17 NITRIC OXIDE MALLINCKRODT HOSP Efficacy Approval
10/09/2015 ZELAPAR
NDA #021479		 SUPPL-7 SELEGILINE HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
10/09/2015 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-49 DOXORUBICIN HYDROCHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
10/09/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #077527		 SUPPL-2 DROSPIRENONE; ETHINYL ESTRADIOL BARR Labeling Approval
10/09/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #077527		 SUPPL-3 DROSPIRENONE; ETHINYL ESTRADIOL BARR Labeling Approval
10/09/2015 NIACIN
ANDA #090446		 SUPPL-3 NIACIN LUPIN LTD Manufacturing (CMC) Approval
10/09/2015 NIACIN
ANDA #090860		 SUPPL-3 NIACIN LUPIN LTD Manufacturing (CMC) Approval
10/09/2015 NIACIN
ANDA #090892		 SUPPL-3 NIACIN LUPIN LTD Manufacturing (CMC) Approval
10/09/2015 OPDIVO
BLA #125554		 SUPPL-5 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
10/09/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202253		 SUPPL-1 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
10/09/2015 MILNACIPRAN HYDROCHLORIDE
ANDA #205062		 ORIG-1 MILNACIPRAN HYDROCHLORIDE PAR PHARM INC Tentative Approval
10/12/2015 TROKENDI XR
NDA #201635		 SUPPL-10 TOPIRAMATE SUPERNUS PHARMS Manufacturing (CMC) Approval
10/13/2015 BICILLIN C-R
NDA #050138		 SUPPL-236 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
10/13/2015 BICILLIN C-R 900/300
NDA #050138		 SUPPL-236 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
10/13/2015 BICILLIN L-A
NDA #050141		 SUPPL-233 PENICILLIN G BENZATHINE KING PHARMS LLC Labeling Approval
10/13/2015 TACROLIMUS
ANDA #090509		 SUPPL-9 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
10/13/2015 TACROLIMUS
ANDA #090509		 SUPPL-11 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #091585		 ORIG-1 MEMANTINE HYDROCHLORIDE JUBILANT GENERICS Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #200022		 ORIG-1 MEMANTINE HYDROCHLORIDE UNICHEM Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #200155		 ORIG-1 MEMANTINE HYDROCHLORIDE TORRENT Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #200891		 ORIG-1 MEMANTINE HYDROCHLORIDE ALEMBIC Approval
10/13/2015 CYTARABINE
ANDA #200916		 SUPPL-3 CYTARABINE MYLAN LABS LTD Labeling Approval
10/13/2015 PALONOSETRON HYDROCHLORIDE
ANDA #202521		 ORIG-1 PALONOSETRON HYDROCHLORIDE SANDOZ Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #202790		 ORIG-1 MEMANTINE HYDROCHLORIDE MACLEODS PHARMS LTD Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #202840		 ORIG-1 MEMANTINE HYDROCHLORIDE MACLEODS PHARMS LTD Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #203175		 ORIG-1 MEMANTINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
10/13/2015 CLONIDINE HYDROCHLORIDE
ANDA #203320		 SUPPL-1 CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
10/13/2015 CLONIDINE HYDROCHLORIDE
ANDA #203320		 SUPPL-2 CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/13/2015 MEMANTINE HYDROCHLORIDE
ANDA #204033		 ORIG-1 MEMANTINE HYDROCHLORIDE CHARTWELL MOLECULAR Approval
10/13/2015 ACIPHEX SPRINKLE
NDA #204736		 SUPPL-6 RABEPRAZOLE SODIUM AYTU Manufacturing (CMC) Approval
10/13/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-6 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Labeling Approval
10/14/2015 GLYSET
NDA #020682		 SUPPL-12 MIGLITOL PFIZER Manufacturing (CMC) Approval
10/14/2015 CEFACLOR
ANDA #065412		 SUPPL-1 CEFACLOR YUNG SHIN PHARM Labeling Approval
10/14/2015 VERAPAMIL HYDROCHLORIDE
ANDA #071881		 SUPPL-5 VERAPAMIL HYDROCHLORIDE HERITAGE PHARMS Manufacturing (CMC) Approval
10/14/2015 PACLITAXEL
ANDA #078167		 SUPPL-7 PACLITAXEL SANDOZ Labeling Approval
10/14/2015 PACLITAXEL
ANDA #078167		 SUPPL-12 PACLITAXEL SANDOZ Labeling Approval
10/14/2015 CICLOPIROX
ANDA #078266		 SUPPL-2 CICLOPIROX PADAGIS US Labeling Approval
10/14/2015 CICLOPIROX
ANDA #078594		 SUPPL-5 CICLOPIROX PADAGIS US Labeling Approval
10/14/2015 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
ANDA #090315		 SUPPL-2 MIDAZOLAM HYDROCHLORIDE STERISCIENCE Labeling Approval
10/14/2015 LOSARTAN POTASSIUM
ANDA #090544		 SUPPL-6 LOSARTAN POTASSIUM UPSHER SMITH LABS Labeling Approval
10/14/2015 LOSARTAN POTASSIUM
ANDA #090544		 SUPPL-7 LOSARTAN POTASSIUM UPSHER SMITH LABS Labeling Approval
10/14/2015 LOSARTAN POTASSIUM
ANDA #090544		 SUPPL-8 LOSARTAN POTASSIUM UPSHER SMITH LABS Labeling Approval
10/14/2015 CIPROFLOXACIN
ANDA #200563		 SUPPL-2 CIPROFLOXACIN CHARTWELL Labeling Approval
10/14/2015 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #201615		 SUPPL-3 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE CHARTWELL RX Labeling Approval
10/14/2015 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #201615		 SUPPL-4 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE CHARTWELL RX Labeling Approval
10/14/2015 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #201615		 SUPPL-6 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE CHARTWELL RX Labeling Approval
10/14/2015 LOSARTAN POTASSIUM
ANDA #203030		 ORIG-1 LOSARTAN POTASSIUM UNICHEM Approval
10/14/2015 BUNAVAIL
NDA #205637		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BDSI Manufacturing (CMC) Approval
10/14/2015 DICLOFENAC SODIUM
ANDA #208068		 ORIG-1 DICLOFENAC SODIUM PADDOCK LABS Tentative Approval
10/15/2015 MACRODANTIN
NDA #016620		 SUPPL-74 NITROFURANTOIN, MACROCRYSTALLINE ALMATICA Manufacturing (CMC) Approval
10/15/2015 XIFAXAN
NDA #021361		 SUPPL-16 RIFAXIMIN SALIX PHARMS Manufacturing (CMC) Approval
10/15/2015 COMBIGAN
NDA #021398		 SUPPL-7 BRIMONIDINE TARTRATE; TIMOLOL MALEATE ABBVIE Labeling Approval
10/15/2015 TASIGNA
NDA #022068		 SUPPL-21 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
10/15/2015 VERAPAMIL HYDROCHLORIDE
ANDA #074587		 SUPPL-36 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
10/15/2015 VERAPAMIL HYDROCHLORIDE
ANDA #074587		 SUPPL-37 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
10/15/2015 TRAMADOL HYDROCHLORIDE
ANDA #075964		 SUPPL-25 TRAMADOL HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
10/15/2015 RISPERIDONE
ANDA #076904		 SUPPL-7 RISPERIDONE HIKMA Labeling Approval
10/15/2015 SIMVASTATIN
ANDA #077691		 SUPPL-33 SIMVASTATIN AUROBINDO PHARMA Labeling Approval
10/15/2015 FOSPHENYTOIN SODIUM
ANDA #078476		 SUPPL-6 FOSPHENYTOIN SODIUM AMNEAL Labeling Approval
10/15/2015 FENOFIBRATE
ANDA #090856		 SUPPL-5 FENOFIBRATE LUPIN LTD Manufacturing (CMC) Approval
10/15/2015 TRAMADOL HYDROCHLORIDE
ANDA #200503		 SUPPL-3 TRAMADOL HYDROCHLORIDE LUPIN LTD Labeling Approval
10/15/2015 IRBESARTAN
ANDA #200832		 SUPPL-2 IRBESARTAN APOTEX INC Labeling Approval
10/15/2015 IRBESARTAN
ANDA #201531		 SUPPL-3 IRBESARTAN LUPIN LTD Labeling Approval
10/15/2015 NEVIRAPINE
ANDA #206448		 ORIG-1 NEVIRAPINE CIPLA Approval
10/16/2015 COMTAN
NDA #020796		 SUPPL-25 ENTACAPONE ORION PHARMA Manufacturing (CMC) Approval
10/16/2015 CLARINEX-D 12 HOUR
NDA #021313		 SUPPL-6 DESLORATADINE; PSEUDOEPHEDRINE SULFATE ORGANON LLC Manufacturing (CMC) Approval
10/16/2015 EXTRANEAL
NDA #021321		 SUPPL-32 ICODEXTRIN BAXTER HLTHCARE REMS Approval
10/16/2015 EMSAM
NDA #021336		 SUPPL-12 SELEGILINE SOMERSET Manufacturing (CMC) Approval
10/16/2015 ROCURONIUM BROMIDE
ANDA #079195		 SUPPL-10 ROCURONIUM BROMIDE SANDOZ Labeling Approval
10/16/2015 ROCURONIUM BROMIDE
ANDA #091458		 SUPPL-4 ROCURONIUM BROMIDE SAGENT PHARMS INC Labeling Approval
10/16/2015 ROPINIROLE HYDROCHLORIDE
ANDA #200462		 SUPPL-4 ROPINIROLE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
10/16/2015 RIZATRIPTAN BENZOATE
ANDA #203334		 ORIG-1 RIZATRIPTAN BENZOATE JUBILANT GENERICS Approval
10/16/2015 TECFIDERA
NDA #204063		 SUPPL-13 DIMETHYL FUMARATE BIOGEN INC Manufacturing (CMC) Approval
10/16/2015 IBANDRONATE SODIUM
ANDA #204222		 ORIG-1 IBANDRONATE SODIUM APOTEX Approval
10/16/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ETHYPHARM USA CORP Approval
10/16/2015 SAVAYSA
NDA #206316		 SUPPL-6 EDOXABAN TOSYLATE DAIICHI SANKYO INC Manufacturing (CMC) Approval
10/16/2015 LENVIMA
NDA #206947		 SUPPL-1 LENVATINIB MESYLATE EISAI INC Manufacturing (CMC) Approval
10/16/2015 ENSTILAR
NDA #207589		 ORIG-1 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Type 3 - New Dosage Form Approval
10/16/2015 PRAXBIND
BLA #761025		 ORIG-1 IDARUCIZUMAB BOEHRINGER INGELHEIM Approval
10/19/2015 FLUMADINE
NDA #019649		 SUPPL-18 RIMANTADINE HYDROCHLORIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
10/19/2015 FAMVIR
NDA #020363		 SUPPL-45 FAMCICLOVIR NOVARTIS Manufacturing (CMC) Approval
10/19/2015 MUCINEX
NDA #021282		 SUPPL-46 GUAIFENESIN RB HLTH Manufacturing (CMC) Approval
10/19/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076211		 SUPPL-21 BENAZEPRIL HYDROCHLORIDE TEVA Labeling Approval
10/19/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076344		 SUPPL-16 BENAZEPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
10/19/2015 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-16 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
10/19/2015 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-17 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
10/19/2015 ESCITALOPRAM OXALATE
ANDA #076765		 SUPPL-5 ESCITALOPRAM OXALATE TEVA PHARMS USA Labeling Approval
10/19/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076820		 SUPPL-15 BENAZEPRIL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
10/19/2015 ROPINIROLE HYDROCHLORIDE
ANDA #077852		 SUPPL-8 ROPINIROLE HYDROCHLORIDE HIKMA Labeling Approval
10/19/2015 LEVETIRACETAM
ANDA #078106		 SUPPL-11 LEVETIRACETAM PRINSTON INC Labeling Approval
10/19/2015 LEVETIRACETAM
ANDA #078106		 SUPPL-12 LEVETIRACETAM PRINSTON INC Labeling Approval
10/19/2015 AMLODIPINE BESYLATE
ANDA #078552		 SUPPL-6 AMLODIPINE BESYLATE EPIC PHARMA LLC Labeling Approval
10/19/2015 ESCITALOPRAM OXALATE
ANDA #078604		 SUPPL-6 ESCITALOPRAM OXALATE INVAGEN PHARMS Labeling Approval
10/19/2015 ROPINIROLE HYDROCHLORIDE
ANDA #078881		 SUPPL-14 ROPINIROLE HYDROCHLORIDE MYLAN Labeling Approval
10/19/2015 ROPINIROLE HYDROCHLORIDE
ANDA #079165		 SUPPL-1 ROPINIROLE HYDROCHLORIDE MLV Labeling Approval
10/19/2015 ROPINIROLE HYDROCHLORIDE
ANDA #079165		 SUPPL-2 ROPINIROLE HYDROCHLORIDE MLV Labeling Approval
10/19/2015 ROPINIROLE HYDROCHLORIDE
ANDA #079229		 SUPPL-1 ROPINIROLE HYDROCHLORIDE ORBION PHARMS Labeling Approval
10/19/2015 LIDOCAINE HYDROCHLORIDE
ANDA #087881		 SUPPL-12 LIDOCAINE HYDROCHLORIDE WOCKHARDT BIO AG Labeling Approval
10/19/2015 OLANZAPINE
ANDA #090881		 SUPPL-3 OLANZAPINE SUN PHARM INDS Labeling Approval
10/19/2015 OLANZAPINE
ANDA #090881		 SUPPL-4 OLANZAPINE SUN PHARM INDS Labeling Approval
10/19/2015 OLANZAPINE
ANDA #090881		 SUPPL-5 OLANZAPINE SUN PHARM INDS Labeling Approval
10/19/2015 OLANZAPINE
ANDA #091038		 SUPPL-2 OLANZAPINE SUN PHARM INDS Labeling Approval
10/19/2015 OLANZAPINE
ANDA #091038		 SUPPL-3 OLANZAPINE SUN PHARM INDS Labeling Approval
10/19/2015 OLANZAPINE
ANDA #091038		 SUPPL-4 OLANZAPINE SUN PHARM INDS Labeling Approval
10/19/2015 TRIMETHOPRIM
ANDA #091437		 SUPPL-1 TRIMETHOPRIM NOVEL LABS INC Labeling Approval
10/19/2015 CIMZIA
BLA #125160		 SUPPL-264 CERTOLIZUMAB PEGOL UCB INC Approval
10/19/2015 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #200674		 SUPPL-1 LEVOFLOXACIN FRESENIUS KABI USA Labeling Approval
10/19/2015 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #200674		 SUPPL-3 LEVOFLOXACIN FRESENIUS KABI USA Labeling Approval
10/19/2015 ROPINIROLE HYDROCHLORIDE
ANDA #201576		 SUPPL-1 ROPINIROLE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
10/19/2015 TELMISARTAN
ANDA #202397		 SUPPL-2 TELMISARTAN MYLAN Labeling Approval
10/19/2015 ZOLEDRONIC ACID
ANDA #202930		 SUPPL-5 ZOLEDRONIC ACID GLAND PHARMA LTD Labeling Approval
10/19/2015 ESOMEPRAZOLE MAGNESIUM
ANDA #203636		 ORIG-1 ESOMEPRAZOLE MAGNESIUM TORRENT Approval
10/19/2015 SODIUM FLUORIDE F-18
ANDA #203777		 ORIG-1 SODIUM FLUORIDE F-18 3D IMAGING DRUG Approval
10/19/2015 AMMONIA N 13
ANDA #203779		 ORIG-1 AMMONIA N-13 3D IMAGING DRUG Approval
10/19/2015 DYANAVEL XR
NDA #208147		 ORIG-1 AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Type 3 - New Dosage Form Approval
10/20/2015 DELESTROGEN
NDA #009402		 SUPPL-47 ESTRADIOL VALERATE PAR STERILE PRODUCTS Manufacturing (CMC) Approval
10/20/2015 SODIUM IODIDE I 131
NDA #016515		 SUPPL-13 SODIUM IODIDE I-131 CURIUM Labeling Approval
10/20/2015 SODIUM IODIDE I 131
NDA #016517		 SUPPL-13 SODIUM IODIDE I-131 CURIUM Labeling Approval
10/20/2015 HUMULIN N
BLA #018781		 SUPPL-159 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
10/20/2015 CYKLOKAPRON
NDA #019281		 SUPPL-36 TRANEXAMIC ACID PFIZER Manufacturing (CMC) Approval
10/20/2015 OXSORALEN-ULTRA
NDA #019600		 SUPPL-18 METHOXSALEN BAUSCH Manufacturing (CMC) Approval
10/20/2015 TIMOPTIC-XE
NDA #020330		 SUPPL-30 TIMOLOL MALEATE BAUSCH AND LOMB INC Manufacturing (CMC) Approval
10/20/2015 PANDEL
NDA #020453		 SUPPL-5 HYDROCORTISONE PROBUTATE ANI PHARMS Manufacturing (CMC) Approval
10/20/2015 CYCLOSET
NDA #020866		 SUPPL-8 BROMOCRIPTINE MESYLATE VEROSCIENCE Labeling Approval
10/20/2015 SIMVASTATIN
ANDA #078155		 SUPPL-21 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
10/20/2015 AMPICILLIN SODIUM
ANDA #090581		 ORIG-1 AMPICILLIN SODIUM SAGENT PHARMS INC Approval
10/20/2015 GUANFACINE HYDROCHLORIDE
ANDA #202238		 ORIG-1 GUANFACINE HYDROCHLORIDE IMPAX LABS INC Approval
10/20/2015 OLANZAPINE
ANDA #202295		 ORIG-1 OLANZAPINE ALKEM LABS LTD Approval
10/20/2015 ZOLEDRONIC ACID
ANDA #202650		 SUPPL-6 ZOLEDRONIC ACID MYLAN LABS LTD Labeling Approval
10/20/2015 LEVOLEUCOVORIN CALCIUM
ANDA #203576		 ORIG-1 LEVOLEUCOVORIN CALCIUM MYLAN TEORANTA Approval
10/20/2015 BLOXIVERZ
NDA #204078		 SUPPL-7 NEOSTIGMINE METHYLSULFATE EXELA PHARMA Labeling Approval
10/20/2015 TRAMADOL HYDROCHLORIDE
ANDA #204421		 ORIG-1 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
10/20/2015 MILNACIPRAN HYDROCHLORIDE
ANDA #205286		 ORIG-1 MILNACIPRAN HYDROCHLORIDE LUPIN LTD Tentative Approval
10/21/2015 CHORIONIC GONADOTROPIN
BLA #017016		 SUPPL-159 GONADOTROPIN, CHORIONIC FERRING Approval
10/21/2015 OMNIPAQUE 12
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 140
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 180
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 210
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 240
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 300
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 350
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 70
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 OMNIPAQUE 9
NDA #018956		 SUPPL-96 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
10/21/2015 CLARITIN
NDA #020641		 SUPPL-37 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
10/21/2015 CLARITIN HIVES RELIEF
NDA #020641		 SUPPL-37 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
10/21/2015 NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #200488		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE MYLAN LABS LTD Approval
10/21/2015 NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #200489		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE MYLAN LABS LTD Approval
10/21/2015 DOCETAXEL
NDA #201195		 SUPPL-8 DOCETAXEL ACCORD HLTHCARE Manufacturing (CMC) Approval
10/21/2015 BREO ELLIPTA
NDA #204275		 SUPPL-8 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Manufacturing (CMC) Approval
10/21/2015 VELTASSA
NDA #205739		 ORIG-1 PATIROMER SORBITEX CALCIUM VIFOR PHARMA Type 1 - New Molecular Entity Approval
10/21/2015 DEXMEDETOMIDINE HYDROCHLORIDE
NDA #206628		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE HQ SPCLT PHARMA Type 5 - New Formulation or New Manufacturer Approval
10/22/2015 INDERAL LA
NDA #018553		 SUPPL-38 PROPRANOLOL HYDROCHLORIDE ANI PHARMS Manufacturing (CMC) Approval
10/22/2015 ACTONEL
NDA #020835		 SUPPL-49 RISEDRONATE SODIUM APIL Manufacturing (CMC) Approval
10/22/2015 ORTHO EVRA
NDA #021180		 SUPPL-47 ETHINYL ESTRADIOL; NORELGESTROMIN JANSSEN PHARMS Labeling Approval
10/22/2015 MIRENA
NDA #021225		 SUPPL-31 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
10/22/2015 ASACOL HD
NDA #021830		 SUPPL-9 MESALAMINE ABBVIE Manufacturing (CMC) Approval
10/22/2015 LOSARTAN POTASSIUM
ANDA #076958		 SUPPL-12 LOSARTAN POTASSIUM TEVA Labeling Approval
10/22/2015 RISPERIDONE
ANDA #077543		 SUPPL-4 RISPERIDONE CHARTWELL MOLECULAR Labeling Approval
10/22/2015 RISPERIDONE
ANDA #090839		 SUPPL-6 RISPERIDONE JUBILANT GENERICS Labeling Approval
10/22/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202253		 SUPPL-4 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/22/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202253		 SUPPL-7 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/22/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #202594		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL MYLAN LABS LTD Approval
10/22/2015 DONEPEZIL HYDROCHLORIDE
ANDA #202656		 ORIG-1 DONEPEZIL HYDROCHLORIDE RISING Approval
10/22/2015 ZOLMITRIPTAN
ANDA #204336		 ORIG-1 ZOLMITRIPTAN MACLEODS PHARMS LTD Approval
10/22/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-8 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Labeling Approval
10/22/2015 JADENU
NDA #206910		 SUPPL-1 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
10/22/2015 JADENU
NDA #206910		 SUPPL-3 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
10/22/2015 VIVLODEX
NDA #207233		 ORIG-1 MELOXICAM ICEUTICA OPERATIONS Type 3 - New Dosage Form Approval
10/22/2015 ONIVYDE
NDA #207793		 ORIG-1 IRINOTECAN HYDROCHLORIDE IPSEN INC Type 5 - New Formulation or New Manufacturer Approval
10/22/2015 TECHNIVIE
NDA #207931		 SUPPL-1 OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE Labeling Approval
10/23/2015 LYSTEDA
NDA #022430		 SUPPL-5 TRANEXAMIC ACID AMRING PHARMS Manufacturing (CMC) Approval
10/23/2015 PRADAXA
NDA #022512		 SUPPL-32 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
10/23/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040422		 SUPPL-20 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BARR Labeling Approval
10/23/2015 BIAXIN
NDA #050662		 SUPPL-57 CLARITHROMYCIN ABBVIE Labeling Approval
10/23/2015 BIAXIN
NDA #050698		 SUPPL-37 CLARITHROMYCIN ABBVIE Labeling Approval
10/23/2015 BIAXIN XL
NDA #050775		 SUPPL-25 CLARITHROMYCIN ABBVIE Labeling Approval
10/23/2015 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #076493		 SUPPL-8 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE TARO Labeling Approval
10/23/2015 VINORELBINE TARTRATE
ANDA #076827		 SUPPL-9 VINORELBINE TARTRATE HOSPIRA Labeling Approval
10/23/2015 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-21 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
10/23/2015 ONDANSETRON HYDROCHLORIDE
ANDA #077303		 SUPPL-1 ONDANSETRON HYDROCHLORIDE CHARTWELL MOLECULES Labeling Approval
10/23/2015 LOSARTAN POTASSIUM
ANDA #090467		 SUPPL-14 LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
10/23/2015 ESCITALOPRAM OXALATE
ANDA #090477		 SUPPL-3 ESCITALOPRAM OXALATE CHARTWELL MOLECULAR Labeling Approval
10/23/2015 VORICONAZOLE
ANDA #090862		 SUPPL-1 VORICONAZOLE SANDOZ INC Labeling Approval
10/23/2015 VORICONAZOLE
ANDA #090862		 SUPPL-2 VORICONAZOLE SANDOZ INC Labeling Approval
10/23/2015 RISEDRONATE SODIUM
ANDA #090886		 SUPPL-2 RISEDRONATE SODIUM SUN PHARM Labeling Approval
10/23/2015 STRENSIQ
BLA #125513		 ORIG-1 ASFOTASE ALFA ALEXION PHARM Approval
10/23/2015 SODIUM FLUORIDE F-18
ANDA #203968		 ORIG-1 SODIUM FLUORIDE F-18 JUBILANT DRAXIMAGE Approval
10/23/2015 EPINEPHRINE
NDA #205029		 SUPPL-1 EPINEPHRINE BPI LABS Efficacy Approval
10/23/2015 BELBUCA
NDA #207932		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE BDSI Type 3 - New Dosage Form Approval
10/23/2015 YONDELIS
NDA #207953		 ORIG-1 TRABECTEDIN JANSSEN PRODS Type 1 - New Molecular Entity Approval
10/26/2015 KENALOG-10
NDA #012041		 SUPPL-43 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
10/26/2015 KENALOG-40
NDA #014901		 SUPPL-43 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
10/26/2015 KENALOG-80
NDA #014901		 SUPPL-43 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
10/26/2015 NICODERM CQ
NDA #020165		 SUPPL-37 NICOTINE CHATTEM SANOFI Manufacturing (CMC) Approval
10/26/2015 ULTANE
NDA #020478		 SUPPL-29 SEVOFLURANE ABBVIE Manufacturing (CMC) Approval
10/26/2015 INFUVITE ADULT
NDA #021163		 SUPPL-31 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
10/26/2015 ELIGARD KIT
NDA #021343		 SUPPL-32 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
10/26/2015 SPIRIVA
NDA #021395		 SUPPL-37 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
10/26/2015 EOVIST
NDA #022090		 SUPPL-12 GADOXETATE DISODIUM BAYER HLTHCARE Manufacturing (CMC) Approval
10/26/2015 FERAHEME
NDA #022180		 SUPPL-15 FERUMOXYTOL COVIS Manufacturing (CMC) Approval
10/26/2015 XARELTO
NDA #022406		 SUPPL-16 RIVAROXABAN JANSSEN PHARMS Manufacturing (CMC) Approval
10/26/2015 VERAPAMIL HYDROCHLORIDE
ANDA #070994		 SUPPL-34 VERAPAMIL HYDROCHLORIDE WATSON LABS Labeling Approval
10/26/2015 VERAPAMIL HYDROCHLORIDE
ANDA #070995		 SUPPL-35 VERAPAMIL HYDROCHLORIDE WATSON LABS Labeling Approval
10/26/2015 VERAPAMIL HYDROCHLORIDE
ANDA #072924		 SUPPL-20 VERAPAMIL HYDROCHLORIDE WATSON LABS Labeling Approval
10/26/2015 METOPROLOL TARTRATE
ANDA #074644		 SUPPL-37 METOPROLOL TARTRATE SUN PHARM INDS INC Labeling Approval
10/26/2015 METOPROLOL TARTRATE
ANDA #074644		 SUPPL-40 METOPROLOL TARTRATE SUN PHARM INDS INC Labeling Approval
10/26/2015 MAGNESIUM SULFATE
ANDA #075151		 SUPPL-13 MAGNESIUM SULFATE HOSPIRA Labeling Approval
10/26/2015 OFLOXACIN
ANDA #076093		 SUPPL-8 OFLOXACIN LARKEN LABS Manufacturing (CMC) Approval
10/26/2015 MOMETASONE FUROATE
ANDA #076499		 SUPPL-10 MOMETASONE FUROATE ENCUBE Labeling Approval
10/26/2015 METOPROLOL TARTRATE
ANDA #076670		 SUPPL-16 METOPROLOL TARTRATE SUN PHARM INDS INC Labeling Approval
10/26/2015 METOPROLOL TARTRATE
ANDA #076670		 SUPPL-18 METOPROLOL TARTRATE SUN PHARM INDS INC Labeling Approval
10/26/2015 ZONISAMIDE
ANDA #077637		 SUPPL-6 ZONISAMIDE RISING Labeling Approval
10/26/2015 ZONISAMIDE
ANDA #077637		 SUPPL-7 ZONISAMIDE RISING Labeling Approval
10/26/2015 ZONISAMIDE
ANDA #077651		 SUPPL-13 ZONISAMIDE GLENMARK GENERICS Labeling Approval
10/26/2015 VINORELBINE TARTRATE
ANDA #078011		 SUPPL-3 VINORELBINE TARTRATE ACTAVIS TOTOWA Labeling Approval
10/26/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078244		 SUPPL-4 ONDANSETRON HYDROCHLORIDE STERISCIENCE Labeling Approval
10/26/2015 ONDANSETRON HYDROCHLORIDE
ANDA #078257		 SUPPL-4 ONDANSETRON HYDROCHLORIDE STERISCIENCE Labeling Approval
10/26/2015 ROCURONIUM BROMIDE
ANDA #078717		 SUPPL-17 ROCURONIUM BROMIDE TEVA PHARMS Labeling Approval
10/26/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090190		 SUPPL-13 PRAMIPEXOLE DIHYDROCHLORIDE SANDOZ Labeling Approval
10/26/2015 LOSARTAN POTASSIUM
ANDA #090428		 SUPPL-8 LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
10/26/2015 URSODIOL
ANDA #090801		 SUPPL-1 URSODIOL GLENMARK GENERICS Labeling Approval
10/26/2015 GALANTAMINE HYDROBROMIDE
ANDA #090957		 SUPPL-9 GALANTAMINE HYDROBROMIDE AUROBINDO PHARMA LTD Labeling Approval
10/26/2015 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091648		 SUPPL-3 HYDROCHLOROTHIAZIDE; TELMISARTAN MYLAN Labeling Approval
10/26/2015 VERAPAMIL HYDROCHLORIDE
ANDA #200878		 SUPPL-1 VERAPAMIL HYDROCHLORIDE APOTEX CORP Labeling Approval
10/26/2015 TRAMADOL HYDROCHLORIDE
ANDA #202390		 SUPPL-1 TRAMADOL HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/26/2015 VALACYCLOVIR HYDROCHLORIDE
ANDA #203047		 SUPPL-1 VALACYCLOVIR HYDROCHLORIDE HETERO LABS LTD V Labeling Approval
10/26/2015 CALCIUM ACETATE
ANDA #203179		 ORIG-1 CALCIUM ACETATE NOSTRUM LABS INC Approval
10/26/2015 TRAMADOL HYDROCHLORIDE
ANDA #203494		 SUPPL-1 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
10/26/2015 SILDENAFIL CITRATE
ANDA #203814		 SUPPL-2 SILDENAFIL CITRATE MACLEODS PHARMS LTD Labeling Approval
10/26/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203855		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
10/26/2015 OMTRYG
NDA #204977		 SUPPL-5 OMEGA-3-ACID ETHYL ESTERS TYPE A OSMOTICA PHARM US Manufacturing (CMC) Approval
10/27/2015 KLARON
NDA #019931		 SUPPL-23 SULFACETAMIDE SODIUM BAUSCH Manufacturing (CMC) Approval
10/27/2015 THALOMID
NDA #020785		 SUPPL-58 THALIDOMIDE BRISTOL-MYERS SQUIBB CO REMS Approval
10/27/2015 CAVERJECT IMPULSE
NDA #021212		 SUPPL-11 ALPROSTADIL PFIZER Labeling Approval
10/27/2015 BRAVELLE
BLA #021289		 SUPPL-27 UROFOLLITROPIN FERRING Approval
10/27/2015 GLUMETZA
NDA #021748		 SUPPL-19 METFORMIN HYDROCHLORIDE SANTARUS INC Manufacturing (CMC) Approval
10/27/2015 PATANASE
NDA #021861		 SUPPL-11 OLOPATADINE HYDROCHLORIDE NOVARTIS Labeling Approval
10/27/2015 REVLIMID
NDA #021880		 SUPPL-45 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
10/27/2015 FIRMAGON
NDA #022201		 SUPPL-11 DEGARELIX ACETATE FERRING Labeling Approval
10/27/2015 ERYTHROCIN
NDA #050609		 SUPPL-36 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
10/27/2015 MYFORTIC
NDA #050791		 SUPPL-24 MYCOPHENOLIC SODIUM NOVARTIS Labeling Approval
10/27/2015 DOXYCYCLINE HYCLATE
ANDA #062269		 SUPPL-28 DOXYCYCLINE HYCLATE CARIBE HOLDINGS Labeling Approval
10/27/2015 RIFAMPIN
ANDA #065421		 SUPPL-3 RIFAMPIN MYLAN LABS LTD Labeling Approval
10/27/2015 TRIMETHOPRIM
ANDA #070049		 SUPPL-31 TRIMETHOPRIM WATSON LABS Labeling Approval
10/27/2015 VERAPAMIL HYDROCHLORIDE
ANDA #075138		 SUPPL-13 VERAPAMIL HYDROCHLORIDE MYLAN Labeling Approval
10/27/2015 VERAPAMIL HYDROCHLORIDE
ANDA #075138		 SUPPL-15 VERAPAMIL HYDROCHLORIDE MYLAN Labeling Approval
10/27/2015 CICLOPIROX
ANDA #076790		 SUPPL-4 CICLOPIROX TARO Labeling Approval
10/27/2015 GLIMEPIRIDE
ANDA #077370		 SUPPL-9 GLIMEPIRIDE PRINSTON INC Labeling Approval
10/27/2015 GLIMEPIRIDE
ANDA #077370		 SUPPL-10 GLIMEPIRIDE PRINSTON INC Labeling Approval
10/27/2015 MELOXICAM
ANDA #077929		 SUPPL-4 MELOXICAM CIPLA Labeling Approval
10/27/2015 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #091235		 SUPPL-1 AMLODIPINE BESYLATE; VALSARTAN TEVA PHARMS USA Labeling Approval
10/27/2015 VINORELBINE TARTRATE
ANDA #200148		 SUPPL-3 VINORELBINE TARTRATE MYLAN LABS LTD Labeling Approval
10/27/2015 HALAVEN
NDA #201532		 SUPPL-13 ERIBULIN MESYLATE EISAI INC Labeling Approval
10/27/2015 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203145		 SUPPL-2 HYDROCHLOROTHIAZIDE; VALSARTAN MACLEODS PHARMS LTD Labeling Approval
10/27/2015 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203145		 SUPPL-5 HYDROCHLOROTHIAZIDE; VALSARTAN MACLEODS PHARMS LTD Labeling Approval
10/27/2015 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203145		 SUPPL-9 HYDROCHLOROTHIAZIDE; VALSARTAN MACLEODS PHARMS LTD Labeling Approval
10/27/2015 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #203865		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE AMNEAL PHARMS Approval
10/27/2015 POMALYST
NDA #204026		 SUPPL-10 POMALIDOMIDE BRISTOL REMS Approval
10/27/2015 LAMOTRIGINE
ANDA #204158		 ORIG-1 LAMOTRIGINE PAR PHARM Approval
10/27/2015 FLUDEOXYGLUCOSE F18
ANDA #204759		 ORIG-1 FLUDEOXYGLUCOSE F-18 KETTERING MEDCTR Approval
10/28/2015 COUMADIN
NDA #009218		 SUPPL-115 WARFARIN SODIUM BRISTOL MYERS SQUIBB Labeling Approval
10/28/2015 NIASPAN
NDA #020381		 SUPPL-52 NIACIN ABBVIE Manufacturing (CMC) Approval
10/28/2015 NIASPAN TITRATION STARTER PACK
NDA #020381		 SUPPL-52 NIACIN ABBVIE Manufacturing (CMC) Approval
10/28/2015 BUSULFEX
NDA #020954		 SUPPL-15 BUSULFAN OTSUKA PHARM Manufacturing (CMC) Approval
10/28/2015 FERAHEME
NDA #022180		 SUPPL-14 FERUMOXYTOL COVIS Manufacturing (CMC) Approval
10/28/2015 PAROMOMYCIN SULFATE
ANDA #065173		 SUPPL-1 PAROMOMYCIN SULFATE HERITAGE PHARMS Manufacturing (CMC) Approval
10/28/2015 TESTOSTERONE
ANDA #076737		 SUPPL-7 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
10/28/2015 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-7 CLOPIDOGREL BISULFATE TEVA Labeling Approval
10/28/2015 CICLOPIROX
ANDA #077092		 SUPPL-3 CICLOPIROX TARO Labeling Approval
10/28/2015 VALACYCLOVIR HYDROCHLORIDE
ANDA #077135		 SUPPL-6 VALACYCLOVIR HYDROCHLORIDE CIPLA Labeling Approval
10/28/2015 AMLODIPINE BESYLATE
ANDA #077516		 SUPPL-1 AMLODIPINE BESYLATE STRIDES PHARMA Manufacturing (CMC) Approval
10/28/2015 TERBINAFINE HYDROCHLORIDE
ANDA #077919		 SUPPL-7 TERBINAFINE HYDROCHLORIDE EMED MEDCL Labeling Approval
10/28/2015 TERBINAFINE HYDROCHLORIDE
ANDA #077919		 SUPPL-10 TERBINAFINE HYDROCHLORIDE EMED MEDCL Labeling Approval
10/28/2015 LINEZOLID
ANDA #078061		 SUPPL-1 LINEZOLID TEVA PHARMS USA Manufacturing (CMC) Approval
10/28/2015 LINEZOLID
ANDA #078061		 SUPPL-2 LINEZOLID TEVA PHARMS USA Labeling Approval
10/28/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078245		 SUPPL-18 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
10/28/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078245		 SUPPL-21 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
10/28/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078245		 SUPPL-22 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
10/28/2015 ROPINIROLE HYDROCHLORIDE
ANDA #090411		 SUPPL-5 ROPINIROLE HYDROCHLORIDE CADILA Labeling Approval
10/28/2015 DULOXETINE HYDROCHLORIDE
ANDA #090780		 ORIG-1 DULOXETINE HYDROCHLORIDE ANCHEN PHARMS Approval
10/28/2015 BLISOVI 24 FE
ANDA #091398		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN LTD Approval
10/28/2015 YERVOY
BLA #125377		 SUPPL-73 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
10/28/2015 ESCITALOPRAM OXALATE
ANDA #202280		 SUPPL-6 ESCITALOPRAM OXALATE JUBILANT CADISTA Labeling Approval
10/28/2015 DULOXETINE HYDROCHLORIDE
ANDA #202336		 ORIG-1 DULOXETINE HYDROCHLORIDE INVENTIA Approval
10/28/2015 CHOLINE C-11
NDA #203155		 SUPPL-5 CHOLINE C-11 MCPRF Manufacturing (CMC) Approval
10/28/2015 ACETAMINOPHEN
NDA #204767		 ORIG-1 ACETAMINOPHEN FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Approval
10/28/2015 KUVAN
NDA #205065		 SUPPL-1 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Manufacturing (CMC) Approval
10/28/2015 ALEVE PM
NDA #205352		 SUPPL-6 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
10/29/2015 MODICON 28
NDA #017735		 SUPPL-117 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/29/2015 ORTHO-NOVUM 1/35-28
NDA #017919		 SUPPL-99 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/29/2015 ORTHO-NOVUM 7/7/7-21
NDA #018985		 SUPPL-63 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/29/2015 ORTHO-NOVUM 7/7/7-28
NDA #018985		 SUPPL-63 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/29/2015 MIRALAX
NDA #022015		 SUPPL-23 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
10/29/2015 TACLONEX
NDA #022185		 SUPPL-19 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
10/29/2015 TACLONEX
NDA #022185		 SUPPL-19 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
10/29/2015 MOMETASONE FUROATE
ANDA #075919		 SUPPL-3 MOMETASONE FUROATE FOUGERA PHARMS Labeling Approval
10/29/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076430		 SUPPL-10 BENAZEPRIL HYDROCHLORIDE RISING Labeling Approval
10/29/2015 MOMETASONE FUROATE
ANDA #076591		 SUPPL-10 MOMETASONE FUROATE ANDA REPOSITORY Labeling Approval
10/29/2015 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #088875		 SUPPL-34 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE WOCKHARDT BIO AG Manufacturing (CMC) Approval
10/29/2015 MEROPENEM
ANDA #090940		 SUPPL-8 MEROPENEM HOSPIRA INC Labeling Approval
10/29/2015 MEROPENEM
ANDA #090940		 SUPPL-12 MEROPENEM HOSPIRA INC Labeling Approval
10/29/2015 VALCHLOR
NDA #202317		 SUPPL-4 MECHLORETHAMINE HYDROCHLORIDE HELSINN Labeling Approval
10/29/2015 VAZCULEP
NDA #204300		 SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE EXELA PHARMA Manufacturing (CMC) Approval
10/29/2015 CHOLINE C-11
ANDA #205690		 ORIG-1 CHOLINE C-11 UNIV TX MD ANDERSON Approval
10/29/2015 SEEBRI
NDA #207923		 ORIG-1 GLYCOPYRROLATE NOVARTIS Type 3 - New Dosage Form Approval
10/29/2015 UTIBRON
NDA #207930		 ORIG-1 GLYCOPYRROLATE; INDACATEROL MALEATE NOVARTIS Type 3 - New Dosage Form and Type 4 - New Combination Approval
10/30/2015 TEGRETOL
NDA #016608		 SUPPL-111 CARBAMAZEPINE NOVARTIS Manufacturing (CMC) Approval
10/30/2015 HEPARIN SODIUM
NDA #017037		 SUPPL-176 HEPARIN SODIUM HIKMA Manufacturing (CMC) Approval
10/30/2015 HEPATOLITE
NDA #018467		 SUPPL-31 TECHNETIUM TC-99M DISOFENIN KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
10/30/2015 RENACIDIN
NDA #019481		 SUPPL-13 CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE UNITED GUARDIAN Labeling Approval
10/30/2015 ACTIGALL
NDA #019594		 SUPPL-34 URSODIOL TEVA BRANDED PHARM Manufacturing (CMC) Approval
10/30/2015 CONDYLOX
NDA #019795		 SUPPL-14 PODOFILOX TEVA BRANDED PHARM Manufacturing (CMC) Approval
10/30/2015 CEREZYME
BLA #020367		 SUPPL-95 IMIGLUCERASE GENZYME Approval
10/30/2015 PRANDIN
NDA #020741		 SUPPL-43 REPAGLINIDE GEMINI LABS LLC Manufacturing (CMC) Approval
10/30/2015 ATROPINE SULFATE
NDA #021146		 SUPPL-15 ATROPINE SULFATE HOSPIRA Labeling Approval
10/30/2015 SPIRONOLACTONE
ANDA #040750		 SUPPL-17 SPIRONOLACTONE OXFORD PHARMS Labeling Approval
10/30/2015 KEFLEX
NDA #050405		 SUPPL-106 CEPHALEXIN PRAGMA Labeling Approval
10/30/2015 MYCOPHENOLATE MOFETIL
ANDA #065410		 SUPPL-10 MYCOPHENOLATE MOFETIL HIKMA Labeling Approval
10/30/2015 MYCOPHENOLATE MOFETIL
ANDA #065413		 SUPPL-11 MYCOPHENOLATE MOFETIL HIKMA Labeling Approval
10/30/2015 MYCOPHENOLATE MOFETIL
ANDA #065457		 SUPPL-10 MYCOPHENOLATE MOFETIL TEVA PHARMS Labeling Approval
10/30/2015 MYCOPHENOLATE MOFETIL
ANDA #065491		 SUPPL-10 MYCOPHENOLATE MOFETIL TEVA PHARMS Labeling Approval
10/30/2015 MYCOPHENOLATE MOFETIL
ANDA #065520		 SUPPL-17 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
10/30/2015 MYCOPHENOLATE MOFETIL
ANDA #065521		 SUPPL-14 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
10/30/2015 TRIMETHOPRIM
ANDA #070494		 SUPPL-15 TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
10/30/2015 TRIMETHOPRIM
ANDA #070495		 SUPPL-13 TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
10/30/2015 CAPTOPRIL
ANDA #074322		 SUPPL-22 CAPTOPRIL TEVA Labeling Approval
10/30/2015 SUCRALFATE
ANDA #074415		 SUPPL-19 SUCRALFATE NOSTRUM LABS INC Labeling Approval
10/30/2015 CAPTOPRIL
ANDA #074532		 SUPPL-8 CAPTOPRIL WOCKHARDT Labeling Approval
10/30/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #078015		 SUPPL-7 TAMSULOSIN HYDROCHLORIDE SANDOZ Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #078235		 SUPPL-15 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #078235		 SUPPL-16 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #078235		 SUPPL-18 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/30/2015 TRANDOLAPRIL
ANDA #078438		 SUPPL-14 TRANDOLAPRIL AUROBINDO PHARMA Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #078877		 SUPPL-9 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #078877		 SUPPL-10 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #078877		 SUPPL-11 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/30/2015 PAMIDRONATE DISODIUM
ANDA #078942		 SUPPL-5 PAMIDRONATE DISODIUM AM REGENT Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #090278		 SUPPL-10 TOPIRAMATE SUN PHARM Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #090278		 SUPPL-11 TOPIRAMATE SUN PHARM Labeling Approval
10/30/2015 TOPIRAMATE
ANDA #090278		 SUPPL-13 TOPIRAMATE SUN PHARM Labeling Approval
10/30/2015 VALSARTAN
ANDA #090866		 SUPPL-2 VALSARTAN MYLAN Labeling Approval
10/30/2015 VORICONAZOLE
ANDA #200265		 SUPPL-8 VORICONAZOLE SANDOZ INC Labeling Approval
10/30/2015 VORICONAZOLE
ANDA #200265		 SUPPL-9 VORICONAZOLE SANDOZ INC Labeling Approval
10/30/2015 TRAMADOL HYDROCHLORIDE
ANDA #200491		 SUPPL-4 TRAMADOL HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
10/30/2015 SPIRONOLACTONE
ANDA #202187		 SUPPL-1 SPIRONOLACTONE AUROBINDO PHARMA Labeling Approval
10/30/2015 MORPHINE SULFATE
ANDA #202310		 ORIG-1 MORPHINE SULFATE CHARTWELL MOLECULAR Approval
10/30/2015 SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
ANDA #202365		 ORIG-1 SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE WATSON LABS INC Tentative Approval
10/30/2015 DONEPEZIL HYDROCHLORIDE
ANDA #202782		 ORIG-1 DONEPEZIL HYDROCHLORIDE LUPIN LTD Approval
10/30/2015 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #202894		 ORIG-1 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE GLENMARK PHARMS Approval
10/30/2015 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ANDA #203335		 ORIG-1 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE DR REDDYS LABS SA Approval
10/30/2015 FLUDEOXYGLUCOSE F18
ANDA #203778		 ORIG-1 FLUDEOXYGLUCOSE F-18 3D IMAGING DRUG Approval
10/30/2015 BUTALBITAL AND ACETAMINOPHEN
ANDA #205120		 ORIG-1 ACETAMINOPHEN; BUTALBITAL ALVOGEN Approval
10/30/2015 TELMISARTAN
ANDA #205150		 ORIG-1 TELMISARTAN INVENTIA Approval
10/30/2015 ITRACONAZOLE
ANDA #205573		 ORIG-1 ITRACONAZOLE AMNEAL PHARMS Approval
10/30/2015 SAVAYSA
NDA #206316		 SUPPL-3 EDOXABAN TOSYLATE DAIICHI SANKYO INC Manufacturing (CMC) Approval
10/31/2015 CALCITONIN-SALMON
ANDA #076396		 SUPPL-5 CALCITONIN SALMON APOTEX INC Labeling Approval
10/31/2015 CALCITONIN-SALMON
ANDA #076396		 SUPPL-6 CALCITONIN SALMON APOTEX INC Labeling Approval
10/31/2015 CALCITONIN-SALMON
ANDA #076979		 SUPPL-13 CALCITONIN SALMON PAR PHARM Labeling Approval
10/31/2015 MOMETASONE FUROATE
ANDA #077061		 SUPPL-3 MOMETASONE FUROATE FOUGERA PHARMS Labeling Approval
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