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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 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
07/01/2013 ORTHO EVRA
NDA #021180		 SUPPL-44 ETHINYL ESTRADIOL; NORELGESTROMIN JANSSEN PHARMS Labeling Approval
07/01/2013 TRACLEER
NDA #021290		 SUPPL-25 BOSENTAN ACTELION REMS Approval
07/01/2013 RIZATRIPTAN BENZOATE
ANDA #078739		 ORIG-1 RIZATRIPTAN BENZOATE CHARTWELL RX Approval
07/01/2013 FINASTERIDE
ANDA #090060		 ORIG-1 FINASTERIDE HETERO LABS LTD III Approval
07/01/2013 FINASTERIDE
ANDA #090508		 ORIG-1 FINASTERIDE SUN PHARM Approval
07/01/2013 RASAGILINE MESYLATE
ANDA #201823		 ORIG-1 RASAGILINE MESYLATE WATSON LABS INC Approval
07/01/2013 RIZATRIPTAN BENZOATE
ANDA #201914		 ORIG-1 RIZATRIPTAN BENZOATE GLENMARK PHARMS LTD Approval
07/01/2013 RIZATRIPTAN BENZOATE
ANDA #202477		 ORIG-1 RIZATRIPTAN BENZOATE APOTEX INC Approval
07/01/2013 RILUZOLE
ANDA #203042		 ORIG-1 RILUZOLE PHARMOBEDIENT Approval
07/01/2013 RIZATRIPTAN BENZOATE
ANDA #203062		 ORIG-1 RIZATRIPTAN BENZOATE AUROBINDO PHARMA LTD Approval
07/01/2013 RIZATRIPTAN BENZOATE
ANDA #203478		 ORIG-1 RIZATRIPTAN BENZOATE NATCO PHARMA LTD Approval
07/01/2013 RIZATRIPTAN BENZOATE
ANDA #204339		 ORIG-1 RIZATRIPTAN BENZOATE INVAGEN PHARMS Approval
07/02/2013 EFUDEX
NDA #016831		 SUPPL-56 FLUOROURACIL EXTROVIS Manufacturing (CMC) Approval
07/02/2013 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-33 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Efficacy Approval
07/02/2013 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-34 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Efficacy Approval
07/02/2013 SPRIX
NDA #022382		 SUPPL-7 KETOROLAC TROMETHAMINE COSETTE Manufacturing (CMC) Approval
07/02/2013 ZIANA
NDA #050802		 SUPPL-14 CLINDAMYCIN PHOSPHATE; TRETINOIN BAUSCH Manufacturing (CMC) Approval
07/02/2013 CEFTRIAXONE
ANDA #065263		 SUPPL-11 CEFTRIAXONE SODIUM LUPIN Labeling Approval
07/02/2013 PHENDIMETRAZINE TARTRATE
ANDA #089452		 SUPPL-15 PHENDIMETRAZINE TARTRATE CHARTWELL Labeling Approval
07/02/2013 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-8 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Manufacturing (CMC) Approval
07/02/2013 MINOCYCLINE HYDROCHLORIDE
ANDA #090422		 SUPPL-8 MINOCYCLINE HYDROCHLORIDE SANDOZ Labeling Approval
07/02/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #091254		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
07/02/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #091254		 SUPPL-5 PRAMIPEXOLE DIHYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
07/02/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #091254		 SUPPL-7 PRAMIPEXOLE DIHYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
07/02/2013 PEGASYS
BLA #103964		 SUPPL-5245 PEGINTERFERON ALFA-2A Pharmaand GmbH Approval
07/02/2013 ACTEMRA
BLA #125276		 SUPPL-75 TOCILIZUMAB GENENTECH Approval
07/03/2013 SUBLIMAZE PRESERVATIVE FREE
NDA #016619		 SUPPL-34 FENTANYL CITRATE RISING Labeling Approval
07/03/2013 TENEX
NDA #019032		 SUPPL-21 GUANFACINE HYDROCHLORIDE PROMIUS PHARMA Labeling Approval
07/03/2013 PERIOCHIP
NDA #020774		 SUPPL-13 CHLORHEXIDINE GLUCONATE DEXCEL PHARMA Manufacturing (CMC) Approval
07/03/2013 GEODON
NDA #020825		 SUPPL-41 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
07/03/2013 GEODON
NDA #020919		 SUPPL-27 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
07/03/2013 BENICAR
NDA #021286		 SUPPL-27 OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
07/03/2013 OXYTROL
NDA #021351		 SUPPL-7 OXYBUTYNIN ALLERGAN Manufacturing (CMC) Approval
07/03/2013 GEODON
NDA #021483		 SUPPL-7 ZIPRASIDONE HYDROCHLORIDE PFIZER INC Labeling Approval
07/03/2013 BENICAR HCT
NDA #021532		 SUPPL-22 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
07/03/2013 AZOR
NDA #022100		 SUPPL-22 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
07/03/2013 CAPRELSA
NDA #022405		 SUPPL-4 VANDETANIB GENZYME CORP Labeling Approval
07/03/2013 GABAPENTIN
ANDA #076672		 ORIG-1 GABAPENTIN TARO Approval
07/03/2013 PROLIA
BLA #125320		 SUPPL-113 DENOSUMAB AMGEN Approval
07/03/2013 XGEVA
BLA #125320		 SUPPL-113 DENOSUMAB AMGEN Approval
07/03/2013 TRIBENZOR
NDA #200175		 SUPPL-14 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
07/03/2013 TRIBENZOR
NDA #200175		 SUPPL-15 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
07/03/2013 ZELBORAF
NDA #202429		 SUPPL-2 VEMURAFENIB HOFFMANN LA ROCHE Labeling Approval
07/03/2013 ZELBORAF
NDA #202429		 SUPPL-3 VEMURAFENIB HOFFMANN LA ROCHE Labeling Approval
07/03/2013 ZUBSOLV
NDA #204242		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EDENBRIDGE PHARMS Type 5 - New Formulation or New Manufacturer Approval
07/05/2013 DILAUDID
NDA #019892		 SUPPL-23 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
07/05/2013 SARAFEM
NDA #021860		 SUPPL-6 FLUOXETINE HYDROCHLORIDE APIL Labeling Approval
07/05/2013 SARAFEM
NDA #021860		 SUPPL-7 FLUOXETINE HYDROCHLORIDE APIL Labeling Approval
07/05/2013 SARAFEM
NDA #021860		 SUPPL-8 FLUOXETINE HYDROCHLORIDE APIL Labeling Approval
07/05/2013 SARAFEM
NDA #021860		 SUPPL-9 FLUOXETINE HYDROCHLORIDE APIL Labeling Approval
07/05/2013 DONEPEZIL HYDROCHLORIDE
ANDA #202114		 ORIG-1 DONEPEZIL HYDROCHLORIDE RISING Approval
07/05/2013 CARBON DIOXIDE, USP
NDA #205764		 ORIG-1 CARBON DIOXIDE LINDE NORTH AMERICA INC Medical Gas Approval
07/05/2013 MEDICAL AIR, USP
NDA #205765		 ORIG-1 MEDICAL AIR LINDE NORTH AMERICA INC Medical Gas Approval
07/05/2013 NITROGEN, NF
NDA #205766		 ORIG-1 NITROGEN LINDE NORTH AMERICA INC Medical Gas Approval
07/05/2013 OXYGEN, USP
NDA #205767		 ORIG-1 OXYGEN LINDE NORTH AMERICA INC Medical Gas Approval
07/05/2013 CARBON DIOXIDE, USP
NDA #205815		 ORIG-1 CARBON DIOXIDE LINDE MERCHANT PRODUCTIONS INC Medical Gas Approval
07/05/2013 NITROGEN, NF
NDA #205816		 ORIG-1 NITROGEN LINDE GAS PUERTO RICO INC Medical Gas Approval
07/05/2013 OXYGEN, USP
NDA #205817		 ORIG-1 OXYGEN LINDE NORTH AMERICA INC Medical Gas Approval
07/05/2013 OXYGEN, USP
NDA #205818		 ORIG-1 OXYGEN LINDE GAS PUERTO RICO INC Medical Gas Approval
07/08/2013 TRUVADA
NDA #021752		 SUPPL-39 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing (CMC) Approval
07/08/2013 INTELENCE
NDA #022187		 SUPPL-15 ETRAVIRINE JANSSEN R AND D Manufacturing (CMC) Approval
07/08/2013 CYCLOSPORINE
ANDA #065017		 SUPPL-20 CYCLOSPORINE SANDOZ Labeling Approval
07/08/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065096		 SUPPL-27 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA PHARMS USA Labeling Approval
07/08/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065101		 SUPPL-26 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
07/08/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065205		 SUPPL-15 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
07/08/2013 CEVIMELINE HYDROCHLORIDE
ANDA #091591		 ORIG-1 CEVIMELINE HYDROCHLORIDE HIKMA Approval
07/09/2013 DIPRIVAN
NDA #019627		 SUPPL-60 PROPOFOL FRESENIUS KABI USA Manufacturing (CMC) Approval
07/09/2013 CIPRO HC
NDA #020805		 SUPPL-10 CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE SANDOZ Manufacturing (CMC) Approval
07/09/2013 OVIDREL
BLA #021149		 SUPPL-17 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
07/09/2013 SUSTIVA
NDA #021360		 SUPPL-32 EFAVIRENZ BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
07/09/2013 SYNERA
NDA #021623		 SUPPL-22 LIDOCAINE; TETRACAINE GALEN SPECIALTY Manufacturing (CMC) Approval
07/09/2013 EPITOL
ANDA #070541		 SUPPL-49 CARBAMAZEPINE TEVA Manufacturing (CMC) Approval
07/09/2013 AMLODIPINE BESYLATE
ANDA #078925		 SUPPL-2 AMLODIPINE BESYLATE ALKEM Manufacturing (CMC) Approval
07/09/2013 METHYLPHENIDATE HYDROCHLORIDE
ANDA #091695		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Approval
07/09/2013 DELZICOL
NDA #204412		 SUPPL-1 MESALAMINE ABBVIE Manufacturing (CMC) Approval
07/10/2013 MONISTAT 7
NDA #017450		 SUPPL-63 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 MONISTAT 7
NDA #018520		 SUPPL-24 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 MONISTAT 3
NDA #018888		 SUPPL-15 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 LUPRON DEPOT
NDA #019732		 SUPPL-40 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
07/10/2013 MONISTAT 7 COMBINATION PACK
NDA #020288		 SUPPL-17 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 LUPRON DEPOT
NDA #020517		 SUPPL-35 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
07/10/2013 MONISTAT 3 COMBINATION PACK
NDA #020670		 SUPPL-22 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 MONISTAT 3
NDA #020827		 SUPPL-21 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 MONISTAT DUAL- PAK
NDA #020968		 SUPPL-3 MICONAZOLE NITRATE PERSONAL PRODS Manufacturing (CMC) Approval
07/10/2013 MONISTAT 3 COMBINATION PACK
NDA #021261		 SUPPL-14 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 MONISTAT 3 COMBINATION PACK (PREFILLED)
NDA #021261		 SUPPL-14 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 MONISTAT 1 COMBINATION PACK
NDA #021308		 SUPPL-19 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
07/10/2013 OXYTROL
NDA #021351		 SUPPL-12 OXYBUTYNIN ALLERGAN Manufacturing (CMC) Approval
07/10/2013 LUVOX
NDA #021519		 SUPPL-6 FLUVOXAMINE MALEATE ANI PHARMS Manufacturing (CMC) Approval
07/10/2013 DURAPREP
NDA #021586		 SUPPL-4 IODINE POVACRYLEX; ISOPROPYL ALCOHOL SOLVENTUM Manufacturing (CMC) Approval
07/10/2013 EXPAREL
NDA #022496		 SUPPL-4 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
07/10/2013 GABAPENTIN
ANDA #075435		 SUPPL-18 GABAPENTIN TEVA PHARMS Labeling Approval
07/10/2013 MORPHINE SULFATE
NDA #201517		 SUPPL-5 MORPHINE SULFATE CHARTWELL MOLECULAR Manufacturing (CMC) Approval
07/10/2013 STENDRA
NDA #202276		 SUPPL-4 AVANAFIL VIVUS LLC Manufacturing (CMC) Approval
07/10/2013 KHEDEZLA
NDA #204683		 ORIG-1 DESVENLAFAXINE OSMOTICA PHARM CORP Type 5 - New Formulation or New Manufacturer Approval
07/11/2013 FEMARA
NDA #020726		 SUPPL-25 LETROZOLE NOVARTIS PHARMS Manufacturing (CMC) Approval
07/11/2013 KETEK
NDA #021144		 SUPPL-16 TELITHROMYCIN SANOFI AVENTIS US Manufacturing (CMC) Approval
07/11/2013 TIROSINT
NDA #021924		 SUPPL-10 LEVOTHYROXINE SODIUM IBSA Manufacturing (CMC) Approval
07/11/2013 NUCYNTA
NDA #022304		 SUPPL-7 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
07/11/2013 NUCYNTA
NDA #022304		 SUPPL-8 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
07/11/2013 NUCYNTA
NDA #022304		 SUPPL-9 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
07/11/2013 NUCYNTA
NDA #022304		 SUPPL-11 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
07/11/2013 NUCYNTA
NDA #022304		 SUPPL-12 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
07/11/2013 CLARITHROMYCIN
ANDA #065174		 SUPPL-9 CLARITHROMYCIN SUN PHARM INDS LTD Labeling Approval
07/11/2013 AZITHROMYCIN
ANDA #065246		 SUPPL-16 AZITHROMYCIN PLIVA Labeling Approval
07/11/2013 CLARITHROMYCIN
ANDA #065382		 SUPPL-4 CLARITHROMYCIN SUN PHARM INDS LTD Labeling Approval
07/11/2013 STRONTIUM CHLORIDE SR-89
ANDA #075941		 SUPPL-11 STRONTIUM CHLORIDE SR-89 Q BIOMED Manufacturing (CMC) Approval
07/11/2013 REPAGLINIDE
ANDA #077571		 ORIG-1 REPAGLINIDE SUN PHARM INDS INC Approval
07/11/2013 EPLERENONE
ANDA #078482		 SUPPL-3 EPLERENONE CHARTWELL RX Labeling Approval
07/11/2013 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 ORIG-2 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
07/11/2013 ALFUZOSIN HYDROCHLORIDE
ANDA #079054		 SUPPL-3 ALFUZOSIN HYDROCHLORIDE TORRENT PHARMS Labeling Approval
07/11/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #090733		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE PH HEALTH Approval
07/11/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #090734		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE PH HEALTH Approval
07/11/2013 HYDROXYZINE PAMOATE
ANDA #201507		 SUPPL-1 HYDROXYZINE PAMOATE HERITAGE PHARMA Manufacturing (CMC) Approval
07/11/2013 SUPRENZA
NDA #202088		 SUPPL-6 PHENTERMINE HYDROCHLORIDE CITIUS PHARMS Labeling Approval
07/11/2013 QUININE SULFATE
ANDA #202581		 SUPPL-3 QUININE SULFATE AUROBINDO PHARMA USA Labeling Approval
07/11/2013 DECITABINE
ANDA #203131		 ORIG-1 DECITABINE DR REDDYS Approval
07/11/2013 MINASTRIN 24 FE
NDA #203667		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
07/12/2013 BACTRIM
NDA #017377		 SUPPL-68 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/12/2013 BACTRIM
NDA #017377		 SUPPL-73 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/12/2013 BACTRIM DS
NDA #017377		 SUPPL-68 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/12/2013 BACTRIM DS
NDA #017377		 SUPPL-73 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/12/2013 TRI-LUMA
NDA #021112		 SUPPL-7 FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN GALDERMA LABS LP Manufacturing (CMC) Approval
07/12/2013 FANAPT
NDA #022192		 SUPPL-10 ILOPERIDONE VANDA PHARMS INC Manufacturing (CMC) Approval
07/12/2013 RAPAFLO
NDA #022206		 SUPPL-12 SILODOSIN ABBVIE Labeling Approval
07/12/2013 AZACTAM IN PLASTIC CONTAINER
NDA #050632		 SUPPL-16 AZTREONAM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
07/12/2013 FOLIC ACID
ANDA #091145		 ORIG-1 FOLIC ACID AIPING PHARM INC Approval
07/12/2013 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #091234		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL NOVAST LABS Approval
07/12/2013 LATUDA
NDA #200603		 SUPPL-15 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Manufacturing (CMC) Approval
07/12/2013 GILOTRIF
NDA #201292		 ORIG-1 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Type 1 - New Molecular Entity Approval
07/12/2013 OXYCODONE HYDROCHLORIDE
ANDA #203208		 ORIG-1 OXYCODONE HYDROCHLORIDE HIKMA Approval
07/12/2013 GABAPENTIN
ANDA #203244		 ORIG-1 GABAPENTIN STRIDES PHARMA Approval
07/13/2013 INFUVITE ADULT
NDA #021163		 SUPPL-26 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
07/13/2013 MEDICAL AIR, USP
NDA #205796		 ORIG-1 MEDICAL AIR MACHINE & WELDING SUPPLY CO Medical Gas Approval
07/13/2013 OXYGEN, USP
NDA #205827		 ORIG-1 OXYGEN AIR LIQUIDE AMERICA LP Medical Gas Approval
07/13/2013 MEDICAL AIR, USP
NDA #205828		 ORIG-1 MEDICAL AIR AIR LIQUIDE AMERICA LP Medical Gas Approval
07/13/2013 NITROGEN, NF
NDA #205829		 ORIG-1 NITROGEN AIR LIQUIDE AMERICA LP Medical Gas Approval
07/14/2013 MEDICAL AIR, USP
NDA #205803		 ORIG-1 MEDICAL AIR WYNN L MADER, INDUSTRIAL GAS DISTRIBUTORS Medical Gas Approval
07/14/2013 MEDICAL AIR, USP
NDA #205804		 ORIG-1 MEDICAL AIR PURITY CYLINDER GASES, INC Medical Gas Approval
07/14/2013 NITROGEN, NF
NDA #205805		 ORIG-1 NITROGEN NORCO INC Medical Gas Approval
07/14/2013 MEDICAL AIR, USP
NDA #205809		 ORIG-1 MEDICAL AIR WESTAIR GASES & EQUIPMENT INC Medical Gas Approval
07/14/2013 HELIUM, USP
NDA #205819		 ORIG-1 HELIUM NORCO INC Medical Gas Approval
07/14/2013 OXYGEN, USP
NDA #205820		 ORIG-1 OXYGEN NORCO INC Medical Gas Approval
07/14/2013 MEDICAL AIR, USP
NDA #205821		 ORIG-1 MEDICAL AIR SCOTT-GROSS COMPANY Medical Gas Approval
07/15/2013 CORGARD
NDA #018063		 SUPPL-63 NADOLOL USWM Labeling Approval
07/15/2013 CORZIDE
NDA #018647		 SUPPL-25 BENDROFLUMETHIAZIDE; NADOLOL KING PHARMS LLC Labeling Approval
07/15/2013 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-62 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
07/15/2013 FEMHRT
NDA #021065		 SUPPL-22 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
07/15/2013 MIRAPEX ER
NDA #022421		 SUPPL-8 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
07/15/2013 AMPICILLIN AND SULBACTAM
ANDA #065316		 SUPPL-5 AMPICILLIN SODIUM; SULBACTAM SODIUM EUROFARMA Labeling Approval
07/15/2013 AMPICILLIN AND SULBACTAM
ANDA #065316		 SUPPL-6 AMPICILLIN SODIUM; SULBACTAM SODIUM EUROFARMA Labeling Approval
07/15/2013 ALENDRONATE SODIUM
ANDA #075710		 SUPPL-9 ALENDRONATE SODIUM IMPAX LABS INC Manufacturing (CMC) Approval
07/15/2013 OXYMORPHONE HYDROCHLORIDE
ANDA #200822		 ORIG-1 OXYMORPHONE HYDROCHLORIDE HIKMA Approval
07/15/2013 LAMOTRIGINE
ANDA #200828		 ORIG-1 LAMOTRIGINE IMPAX LABS INC Approval
07/15/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #201972		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AUROLIFE PHARMA LLC Approval
07/15/2013 OXYCODONE HYDROCHLORIDE
ANDA #204037		 ORIG-1 OXYCODONE HYDROCHLORIDE HIKMA Approval
07/15/2013 MEDICAL AIR, USP
NDA #205826		 ORIG-1 MEDICAL AIR DUPUY OXYGEN Medical Gas Approval
07/16/2013 ELOXATIN
NDA #021759		 SUPPL-16 OXALIPLATIN SANOFI AVENTIS US Labeling Approval
07/16/2013 ELSPAR
BLA #101063		 SUPPL-5169 ASPARAGINASE MERCK Approval
07/16/2013 ELIQUIS
NDA #202155		 SUPPL-1 APIXABAN BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
07/16/2013 ACAMPROSATE CALCIUM
ANDA #202229		 ORIG-1 ACAMPROSATE CALCIUM GLENMARK PHARMS LTD Approval
07/16/2013 NITROGEN, NF
NDA #205839		 ORIG-1 NITROGEN AIRGAS MERCHANTS GASES LLC Medical Gas Approval
07/16/2013 OXYGEN, USP
NDA #205840		 ORIG-1 OXYGEN AIRGAS MERCHANTS GASES LLC Medical Gas Approval
07/17/2013 AGRYLIN
NDA #020333		 SUPPL-20 ANAGRELIDE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
07/17/2013 RANITIDINE HYDROCHLORIDE
ANDA #091534		 SUPPL-1 RANITIDINE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
07/17/2013 REPAGLINIDE
ANDA #201189		 ORIG-1 REPAGLINIDE PADAGIS US Approval
07/17/2013 TRETINOIN
ANDA #202026		 ORIG-1 TRETINOIN RISING Approval
07/17/2013 TRETINOIN
ANDA #202567		 ORIG-1 TRETINOIN RISING Approval
07/18/2013 AZULFIDINE
NDA #007073		 SUPPL-126 SULFASALAZINE PFIZER Labeling Approval
07/18/2013 AZULFIDINE EN-TABS
NDA #007073		 SUPPL-126 SULFASALAZINE PFIZER Labeling Approval
07/18/2013 MEDROL
NDA #011153		 SUPPL-71 METHYLPREDNISOLONE PFIZER Manufacturing (CMC) Approval
07/18/2013 HEPARIN SODIUM
NDA #017651		 SUPPL-60 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/18/2013 CIS-MDP
NDA #018124		 SUPPL-21 TECHNETIUM TC-99M MEDRONATE KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
07/18/2013 MICRO-K
NDA #018238		 SUPPL-41 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
07/18/2013 MICRO-K 10
NDA #018238		 SUPPL-41 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
07/18/2013 NUTROPIN AQ
BLA #020522		 SUPPL-49 SOMATROPIN GENENTECH Approval
07/18/2013 NUTROPIN AQ NUSPIN
BLA #020522		 SUPPL-49 SOMATROPIN GENENTECH Approval
07/18/2013 NUTROPIN AQ PEN
BLA #020522		 SUPPL-49 SOMATROPIN GENENTECH Approval
07/18/2013 HUMALOG
BLA #020563		 SUPPL-141 INSULIN LISPRO RECOMBINANT LILLY Approval
07/18/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-141 INSULIN LISPRO RECOMBINANT LILLY Approval
07/18/2013 HUMALOG PEN
BLA #020563		 SUPPL-141 INSULIN LISPRO RECOMBINANT LILLY Approval
07/18/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-141 INSULIN LISPRO RECOMBINANT LILLY Approval
07/18/2013 LANTUS
BLA #021081		 SUPPL-58 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
07/18/2013 LANTUS SOLOSTAR
BLA #021081		 SUPPL-58 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
07/18/2013 NEURONTIN
NDA #021129		 SUPPL-38 GABAPENTIN VIATRIS Manufacturing (CMC) Approval
07/18/2013 RISPERDAL CONSTA
NDA #021346		 SUPPL-49 RISPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
07/18/2013 FLOVENT HFA
NDA #021433		 SUPPL-22 FLUTICASONE PROPIONATE GLAXO GRP LTD Manufacturing (CMC) Approval
07/18/2013 ALENDRONATE SODIUM
ANDA #076584		 SUPPL-9 ALENDRONATE SODIUM RISING Manufacturing (CMC) Approval
07/18/2013 RISPERIDONE
ANDA #077953		 SUPPL-6 RISPERIDONE APOTEX INC Labeling Approval
07/18/2013 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901		 SUPPL-5 FLUOXETINE HYDROCHLORIDE; OLANZAPINE EPIC PHARMA LLC Labeling Approval
07/18/2013 MINOCYCLINE HYDROCHLORIDE
ANDA #090867		 SUPPL-1 MINOCYCLINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
07/18/2013 SIMPONI ARIA
BLA #125433		 ORIG-1 GOLIMUMAB JANSSEN BIOTECH Approval
07/18/2013 FENOFIBRIC ACID
ANDA #201573		 ORIG-1 CHOLINE FENOFIBRATE PH HEALTH Approval
07/18/2013 LANSOPRAZOLE
ANDA #202194		 SUPPL-2 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
07/19/2013 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-97 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
07/19/2013 CLOZARIL
NDA #019758		 SUPPL-69 CLOZAPINE HERITAGE LIFE Labeling Approval
07/19/2013 CLOZARIL
NDA #019758		 SUPPL-71 CLOZAPINE HERITAGE LIFE Labeling Approval
07/19/2013 NUVARING
NDA #021187		 SUPPL-23 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Manufacturing (CMC) Approval
07/19/2013 FAZACLO ODT
NDA #021590		 SUPPL-21 CLOZAPINE JAZZ Labeling Approval
07/19/2013 FANAPT
NDA #022192		 SUPPL-12 ILOPERIDONE VANDA PHARMS INC Manufacturing (CMC) Approval
07/19/2013 TIMENTIN
NDA #050590		 SUPPL-66 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Manufacturing (CMC) Approval
07/19/2013 RIFAMPIN
ANDA #064150		 SUPPL-20 RIFAMPIN EPIC PHARMA LLC Labeling Approval
07/19/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #091450		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE PHARMOBEDIENT Labeling Approval
07/19/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #091450		 SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE PHARMOBEDIENT Labeling Approval
07/19/2013 METFORMIN HYDROCHLORIDE
ANDA #091664		 ORIG-1 METFORMIN HYDROCHLORIDE LUPIN Approval
07/19/2013 GRANIX
BLA #125294		 SUPPL-7 TBO-FILGRASTIM SICOR BIOTECH Approval
07/19/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202253		 ORIG-1 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Approval
07/19/2013 JANUMET XR
NDA #202270		 SUPPL-4 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Manufacturing (CMC) Approval
07/19/2013 MYRBETRIQ
NDA #202611		 SUPPL-2 MIRABEGRON APGDI Manufacturing (CMC) Approval
07/19/2013 ASTAGRAF XL
NDA #204096		 ORIG-1 TACROLIMUS ASTELLAS Type 3 - New Dosage Form Approval
07/20/2013 HELIUM, USP
NDA #205843		 ORIG-1 HELIUM AIRGAS USA LLC Medical Gas Approval
07/20/2013 MEDICAL AIR, USP
NDA #205845		 ORIG-1 MEDICAL AIR AIRGAS USA LLC Medical Gas Approval
07/20/2013 CARBON DIOXIDE, USP
NDA #205846		 ORIG-1 CARBON DIOXIDE AIRGAS CARBONIC INC Medical Gas Approval
07/20/2013 MEDICAL AIR, USP
NDA #205847		 ORIG-1 MEDICAL AIR OXARC INC Medical Gas Approval
07/21/2013 OXYGEN, USP
NDA #205849		 ORIG-1 OXYGEN PRAXAIR INC Medical Gas Approval
07/21/2013 NITROGEN, NF
NDA #205850		 ORIG-1 NITROGEN PRAXAIR INC Medical Gas Approval
07/21/2013 HELIUM, USP
NDA #205851		 ORIG-1 HELIUM PRAXAIR INC Medical Gas Approval
07/21/2013 CARBON DIOXIDE, USP
NDA #205852		 ORIG-1 CARBON DIOXIDE PRAXAIR INC Medical Gas Approval
07/22/2013 XYLOCAINE
NDA #006488		 SUPPL-87 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
07/22/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-87 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
07/22/2013 REGONOL
NDA #017398		 SUPPL-18 PYRIDOSTIGMINE BROMIDE SANDOZ Manufacturing (CMC) Approval
07/22/2013 ZEMPLAR
NDA #020819		 SUPPL-31 PARICALCITOL ABBVIE Manufacturing (CMC) Approval
07/22/2013 TARGRETIN
NDA #021056		 SUPPL-5 BEXAROTENE BAUSCH Manufacturing (CMC) Approval
07/22/2013 VANIQA
NDA #021145		 SUPPL-8 EFLORNITHINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
07/22/2013 APIDRA
BLA #021629		 SUPPL-24 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
07/22/2013 APIDRA SOLOSTAR
BLA #021629		 SUPPL-24 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
07/22/2013 DUETACT
NDA #021925		 SUPPL-13 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
07/22/2013 LUMIGAN
NDA #022184		 SUPPL-2 BIMATOPROST ABBVIE Manufacturing (CMC) Approval
07/22/2013 CARBAGLU
NDA #022562		 SUPPL-1 CARGLUMIC ACID RECORDATI RARE Manufacturing (CMC) Approval
07/22/2013 RIFAMATE
ANDA #061884		 SUPPL-15 ISONIAZID; RIFAMPIN SANOFI AVENTIS US Labeling Approval
07/22/2013 RIFAMATE
ANDA #061884		 SUPPL-17 ISONIAZID; RIFAMPIN SANOFI AVENTIS US Labeling Approval
07/22/2013 MICONAZOLE NITRATE
ANDA #074366		 SUPPL-9 MICONAZOLE NITRATE COSETTE PHARMS NC Labeling Approval
07/22/2013 HYDROXYZINE PAMOATE
ANDA #086183		 SUPPL-32 HYDROXYZINE PAMOATE SANDOZ Labeling Approval
07/22/2013 LEVOFLOXACIN
ANDA #090787		 SUPPL-1 LEVOFLOXACIN APOTEX INC Labeling Approval
07/22/2013 MONTELUKAST SODIUM
ANDA #091576		 SUPPL-5 MONTELUKAST SODIUM STRIDES PHARMA INTL Labeling Approval
07/22/2013 MONTELUKAST SODIUM
ANDA #091588		 SUPPL-5 MONTELUKAST SODIUM PHARMACO Labeling Approval
07/22/2013 INCIVEK
NDA #201917		 SUPPL-11 TELAPREVIR VERTEX PHARMS Manufacturing (CMC) Approval
07/22/2013 VICTRELIS
NDA #202258		 SUPPL-8 BOCEPREVIR MERCK SHARP DOHME Manufacturing (CMC) Approval
07/23/2013 CORDRAN
NDA #012806		 SUPPL-37 FLURANDRENOLIDE INA PHARMS Manufacturing (CMC) Approval
07/23/2013 CORDRAN SP
NDA #012806		 SUPPL-37 FLURANDRENOLIDE INA PHARMS Manufacturing (CMC) Approval
07/23/2013 CONRAY
NDA #013295		 SUPPL-63 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
07/23/2013 CONRAY 43
NDA #013295		 SUPPL-63 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
07/23/2013 EPI E Z PEN JR
NDA #019430		 SUPPL-54 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
07/23/2013 EPIPEN
NDA #019430		 SUPPL-54 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
07/23/2013 EPIPEN E Z PEN
NDA #019430		 SUPPL-54 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
07/23/2013 EPIPEN JR.
NDA #019430		 SUPPL-54 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
07/23/2013 TERAZOL 7
NDA #019579		 SUPPL-36 TERCONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
07/23/2013 TERAZOL 3
NDA #019641		 SUPPL-29 TERCONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
07/23/2013 TERAZOL 3
NDA #019964		 SUPPL-31 TERCONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
07/23/2013 PENTASA
NDA #020049		 SUPPL-25 MESALAMINE TAKEDA PHARMS USA Labeling Approval
07/23/2013 CLARINEX
NDA #021165		 SUPPL-16 DESLORATADINE ORGANON Manufacturing (CMC) Approval
07/23/2013 RECLAST
NDA #021817		 SUPPL-14 ZOLEDRONIC ACID SANDOZ Manufacturing (CMC) Approval
07/23/2013 HYLENEX RECOMBINANT
BLA #021859		 SUPPL-18 HYALURONIDASE RECOMBINANT HUMAN HALOZYME THERAP Approval
07/23/2013 FAMCICLOVIR
ANDA #091114		 SUPPL-3 FAMCICLOVIR AUROBINDO PHARMA LTD Labeling Approval
07/23/2013 GILOTRIF
NDA #201292		 SUPPL-1 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Labeling Approval
07/23/2013 EDURANT
NDA #202022		 SUPPL-6 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Manufacturing (CMC) Approval
07/23/2013 NEVIRAPINE
ANDA #203176		 SUPPL-2 NEVIRAPINE TECH ORGANIZED Labeling Approval
07/23/2013 MEDICAL AIR, USP
NDA #205859		 ORIG-1 MEDICAL AIR NEXAIR Medical Gas Approval
07/23/2013 OXYGEN, USP
NDA #205862		 ORIG-1 OXYGEN ASPEN AIR Medical Gas Approval
07/23/2013 NITROGEN, NF
NDA #205863		 ORIG-1 NITROGEN ASPEN AIR Medical Gas Approval
07/23/2013 OXYGEN, USP
NDA #205865		 ORIG-1 OXYGEN AIR PRODUCTS AND CHEMICALS INC Medical Gas Approval
07/23/2013 NITROGEN, NF
NDA #205866		 ORIG-1 NITROGEN AIR PRODUCTS AND CHEMICALS INC Medical Gas Approval
07/24/2013 NORVASC
NDA #019787		 SUPPL-57 AMLODIPINE BESYLATE VIATRIS Manufacturing (CMC) Approval
07/24/2013 INFANT'S ADVIL
NDA #020812		 SUPPL-19 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
07/24/2013 PEDIATRIC ADVIL
NDA #020812		 SUPPL-19 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
07/24/2013 INVANZ
NDA #021337		 SUPPL-41 ERTAPENEM SODIUM MSD SUB MERCK Labeling Approval
07/24/2013 VIREAD
NDA #021356		 SUPPL-46 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
07/24/2013 ZINGO
NDA #022114		 SUPPL-2 LIDOCAINE HYDROCHLORIDE POWDER PHARMS Manufacturing (CMC) Approval
07/24/2013 VIREAD
NDA #022577		 SUPPL-3 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
07/24/2013 CELLCEPT
NDA #050759		 SUPPL-34 MYCOPHENOLATE MOFETIL ROCHE PALO Manufacturing (CMC) Approval
07/24/2013 ERYTHROCIN STEARATE
ANDA #060359		 SUPPL-29 ERYTHROMYCIN STEARATE AZURITY Labeling Approval
07/24/2013 ERYTHROMYCIN
ANDA #061621		 SUPPL-40 ERYTHROMYCIN CARNEGIE Labeling Approval
07/24/2013 ERYTHROMYCIN ETHYLSUCCINATE
ANDA #061904		 SUPPL-22 ERYTHROMYCIN ETHYLSUCCINATE CARNEGIE Labeling Approval
07/24/2013 DOXYCYCLINE HYCLATE
ANDA #062676		 SUPPL-40 DOXYCYCLINE HYCLATE SUN PHARM INDUSTRIES Labeling Approval
07/24/2013 DOXYCYCLINE HYCLATE
ANDA #062677		 SUPPL-39 DOXYCYCLINE HYCLATE SUN PHARM INDUSTRIES Labeling Approval
07/24/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065205		 SUPPL-8 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
07/24/2013 NEVIRAPINE
ANDA #077956		 SUPPL-18 NEVIRAPINE CIPLA Labeling Approval
07/24/2013 GALANTAMINE HYDROBROMIDE
ANDA #078189		 SUPPL-5 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
07/24/2013 DONEPEZIL HYDROCHLORIDE
ANDA #202542		 ORIG-1 DONEPEZIL HYDROCHLORIDE PH HEALTH Approval
07/24/2013 DONEPEZIL HYDROCHLORIDE
ANDA #202723		 ORIG-1 DONEPEZIL HYDROCHLORIDE DR REDDYS Approval
07/24/2013 LO MINASTRIN FE
NDA #204654		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Type 5 - New Formulation or New Manufacturer Approval
07/25/2013 PROCARDIA
NDA #018482		 SUPPL-51 NIFEDIPINE PFIZER Labeling Approval
07/25/2013 NIZORAL
NDA #018533		 SUPPL-40 KETOCONAZOLE JANSSEN PHARMS Labeling Approval
07/25/2013 PROCARDIA XL
NDA #019684		 SUPPL-26 NIFEDIPINE PFIZER Labeling Approval
07/25/2013 TOPAMAX
NDA #020505		 SUPPL-51 TOPIRAMATE JANSSEN PHARMS Manufacturing (CMC) Approval
07/25/2013 ZANTAC 75
NDA #020520		 SUPPL-26 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
07/25/2013 KEPPRA
NDA #021035		 SUPPL-89 LEVETIRACETAM UCB INC Labeling Approval
07/25/2013 VFEND
NDA #021267		 SUPPL-42 VORICONAZOLE PF PRISM CV Manufacturing (CMC) Approval
07/25/2013 BUTRANS
NDA #021306		 SUPPL-16 BUPRENORPHINE KNOA PHARMA Manufacturing (CMC) Approval
07/25/2013 KEPPRA
NDA #021505		 SUPPL-30 LEVETIRACETAM UCB INC Labeling Approval
07/25/2013 KEPPRA
NDA #021872		 SUPPL-12 LEVETIRACETAM UCB INC Labeling Approval
07/25/2013 KEPPRA
NDA #021872		 SUPPL-13 LEVETIRACETAM UCB INC Labeling Approval
07/25/2013 KEPPRA XR
NDA #022285		 SUPPL-13 LEVETIRACETAM UCB INC Labeling Approval
07/25/2013 KEPPRA XR
NDA #022285		 SUPPL-15 LEVETIRACETAM UCB INC Labeling Approval
07/25/2013 ORACEA
NDA #050805		 SUPPL-8 DOXYCYCLINE GALDERMA LABS LP Labeling Approval
07/25/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065089		 SUPPL-15 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
07/25/2013 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #077318		 ORIG-1 CETIRIZINE HYDROCHLORIDE CIPLA LTD Approval
07/25/2013 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565		 SUPPL-3 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
07/25/2013 DONEPEZIL HYDROCHLORIDE
ANDA #090056		 SUPPL-3 DONEPEZIL HYDROCHLORIDE AUROBINDO Labeling Approval
07/25/2013 INJECTAFER
NDA #203565		 ORIG-1 FERRIC CARBOXYMALTOSE AM REGENT Type 5 - New Formulation or New Manufacturer Approval
07/25/2013 FETZIMA
NDA #204168		 ORIG-1 LEVOMILNACIPRAN HYDROCHLORIDE ABBVIE Type 2 - New Active Ingredient Approval
07/26/2013 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
07/26/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
07/26/2013 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
07/26/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
07/26/2013 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
07/26/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
07/26/2013 PROZAC
NDA #018936		 SUPPL-100 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
07/26/2013 PROZAC
NDA #018936		 SUPPL-101 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Efficacy Approval
07/26/2013 SARAFEM
NDA #018936		 SUPPL-100 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
07/26/2013 SARAFEM
NDA #018936		 SUPPL-101 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Efficacy Approval
07/26/2013 DURAGESIC-100
NDA #019813		 SUPPL-59 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
07/26/2013 DURAGESIC-12
NDA #019813		 SUPPL-59 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
07/26/2013 DURAGESIC-25
NDA #019813		 SUPPL-59 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
07/26/2013 DURAGESIC-37
NDA #019813		 SUPPL-59 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
07/26/2013 DURAGESIC-50
NDA #019813		 SUPPL-59 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
07/26/2013 DURAGESIC-75
NDA #019813		 SUPPL-59 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
07/26/2013 ZYPREXA
NDA #020592		 SUPPL-63 OLANZAPINE CHEPLAPHARM Efficacy Approval
07/26/2013 ZYPREXA ZYDIS
NDA #021086		 SUPPL-41 OLANZAPINE CHEPLAPHARM Efficacy Approval
07/26/2013 PROZAC WEEKLY
NDA #021235		 SUPPL-21 FLUOXETINE HYDROCHLORIDE LILLY Labeling Approval
07/26/2013 INSPRA
NDA #021437		 SUPPL-12 EPLERENONE UPJOHN Manufacturing (CMC) Approval
07/26/2013 SYMBYAX
NDA #021520		 SUPPL-37 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
07/26/2013 SYMBYAX
NDA #021520		 SUPPL-39 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Efficacy Approval
07/26/2013 ABSTRAL
NDA #022510		 SUPPL-10 FENTANYL CITRATE SENTYNL THERAPS INC Labeling Approval
07/26/2013 CARISOPRODOL
ANDA #040245		 SUPPL-11 CARISOPRODOL CHARTWELL RX Labeling Approval
07/26/2013 GENTAMICIN SULFATE
ANDA #062356		 SUPPL-23 GENTAMICIN SULFATE FRESENIUS KABI USA Labeling Approval
07/26/2013 GENTAMICIN SULFATE
ANDA #062366		 SUPPL-35 GENTAMICIN SULFATE FRESENIUS KABI USA Labeling Approval
07/26/2013 NALOXONE HYDROCHLORIDE
ANDA #070639		 SUPPL-17 NALOXONE HYDROCHLORIDE INTL MEDICATION Labeling Approval
07/26/2013 GLIPIZIDE
ANDA #074223		 SUPPL-16 GLIPIZIDE WATSON LABS TEVA Labeling Approval
07/26/2013 GLIPIZIDE
ANDA #074226		 SUPPL-12 GLIPIZIDE AUROBINDO PHARMA USA Labeling Approval
07/26/2013 GLIPIZIDE
ANDA #074305		 SUPPL-24 GLIPIZIDE AIPING PHARM INC Labeling Approval
07/26/2013 GLIPIZIDE
ANDA #075795		 SUPPL-10 GLIPIZIDE APOTEX Labeling Approval
07/26/2013 GLIPIZIDE
ANDA #075795		 SUPPL-11 GLIPIZIDE APOTEX Labeling Approval
07/26/2013 FLUOXETINE HYDROCHLORIDE
ANDA #076015		 SUPPL-8 FLUOXETINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
07/26/2013 MEFLOQUINE HYDROCHLORIDE
ANDA #076175		 SUPPL-30 MEFLOQUINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
07/26/2013 PRAVASTATIN SODIUM
ANDA #076341		 SUPPL-15 PRAVASTATIN SODIUM APOTEX Labeling Approval
07/26/2013 MEFLOQUINE HYDROCHLORIDE
ANDA #076392		 SUPPL-8 MEFLOQUINE HYDROCHLORIDE BARR Labeling Approval
07/26/2013 MEFLOQUINE HYDROCHLORIDE
ANDA #076523		 SUPPL-7 MEFLOQUINE HYDROCHLORIDE HIKMA Labeling Approval
07/26/2013 OXYBUTYNIN CHLORIDE
ANDA #076644		 SUPPL-13 OXYBUTYNIN CHLORIDE PHARMOBEDIENT Labeling Approval
07/26/2013 OXYBUTYNIN CHLORIDE
ANDA #076702		 SUPPL-11 OXYBUTYNIN CHLORIDE PHARMOBEDIENT Labeling Approval
07/26/2013 CLONAZEPAM
ANDA #077171		 SUPPL-8 CLONAZEPAM PH HEALTH Labeling Approval
07/26/2013 CHOLESTYRAMINE LIGHT
ANDA #077203		 SUPPL-16 CHOLESTYRAMINE PH HEALTH Labeling Approval
07/26/2013 LOVASTATIN
ANDA #078296		 SUPPL-17 LOVASTATIN LUPIN Labeling Approval
07/26/2013 CARISOPRODOL
ANDA #087499		 SUPPL-54 CARISOPRODOL WATSON LABS Labeling Approval
07/26/2013 CARISOPRODOL
ANDA #089346		 SUPPL-35 CARISOPRODOL SUN PHARM INDUSTRIES Labeling Approval
07/26/2013 VENLAFAXINE HYDROCHLORIDE
ANDA #090027		 SUPPL-6 VENLAFAXINE HYDROCHLORIDE PRINSTON INC Labeling Approval
07/26/2013 FINASTERIDE
ANDA #090507		 SUPPL-3 FINASTERIDE SUN PHARM Labeling Approval
07/26/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #090864		 ORIG-1 CYCLOBENZAPRINE HYDROCHLORIDE PAR PHARM INC Tentative Approval
07/26/2013 RAMELTEON
ANDA #091693		 ORIG-1 RAMELTEON DR REDDYS LABS SA Approval
07/26/2013 DOXEPIN HYDROCHLORIDE
ANDA #201951		 ORIG-1 DOXEPIN HYDROCHLORIDE ACTAVIS ELIZABETH Approval
07/26/2013 FENOFIBRATE (MICRONIZED)
ANDA #202252		 ORIG-1 FENOFIBRATE APOTEX Approval
07/26/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE TARO Approval
07/26/2013 FENOFIBRATE
ANDA #202856		 SUPPL-3 FENOFIBRATE MYLAN PHARMS INC Labeling Approval
07/26/2013 CHOLINE C-11
NDA #203155		 SUPPL-1 CHOLINE C-11 MCPRF Manufacturing (CMC) Approval
07/28/2013 BUPROPION HYDROCHLORIDE
ANDA #078866		 SUPPL-4 BUPROPION HYDROCHLORIDE SUN PHARM Labeling Approval
07/29/2013 ULTRAVIST 150
NDA #020220		 SUPPL-40 IOPROMIDE BAYER HLTHCARE Manufacturing (CMC) Approval
07/29/2013 ULTRAVIST 240
NDA #020220		 SUPPL-40 IOPROMIDE BAYER HLTHCARE Manufacturing (CMC) Approval
07/29/2013 ULTRAVIST 300
NDA #020220		 SUPPL-40 IOPROMIDE BAYER HLTHCARE Manufacturing (CMC) Approval
07/29/2013 ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220		 SUPPL-40 IOPROMIDE BAYER HLTHCARE Manufacturing (CMC) Approval
07/29/2013 ULTRAVIST 370
NDA #020220		 SUPPL-40 IOPROMIDE BAYER HLTHCARE Manufacturing (CMC) Approval
07/29/2013 TEGRETOL-XR
NDA #020234		 SUPPL-41 CARBAMAZEPINE NOVARTIS Manufacturing (CMC) Approval
07/29/2013 CELEBREX
NDA #020998		 SUPPL-42 CELECOXIB UPJOHN Manufacturing (CMC) Approval
07/29/2013 VIVITROL
NDA #021897		 SUPPL-20 NALTREXONE ALKERMES REMS Approval
07/29/2013 VIVITROL
NDA #021897		 SUPPL-23 NALTREXONE ALKERMES Labeling Approval
07/29/2013 SPRIX
NDA #022382		 SUPPL-8 KETOROLAC TROMETHAMINE COSETTE Manufacturing (CMC) Approval
07/29/2013 DOXYCYCLINE
ANDA #091277		 ORIG-1 DOXYCYCLINE LUPIN LTD Tentative Approval
07/29/2013 TEFLARO
NDA #200327		 SUPPL-10 CEFTAROLINE FOSAMIL ABBVIE Manufacturing (CMC) Approval
07/29/2013 EDARBI
NDA #200796		 SUPPL-4 AZILSARTAN KAMEDOXOMIL AZURITY Manufacturing (CMC) Approval
07/29/2013 RANOLAZINE
ANDA #201046		 ORIG-1 RANOLAZINE CHARTWELL RX Approval
07/29/2013 ELETRIPTAN HYDROBROMIDE
ANDA #201536		 ORIG-1 ELETRIPTAN HYDROBROMIDE APOTEX INC Tentative Approval
07/30/2013 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-71 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
07/30/2013 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-71 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
07/30/2013 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-71 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
07/30/2013 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-71 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
07/30/2013 ANGIOMAX
NDA #020873		 SUPPL-30 BIVALIRUDIN SANDOZ Manufacturing (CMC) Approval
07/30/2013 PEPCID COMPLETE
NDA #020958		 SUPPL-18 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE KENVUE BRANDS Labeling Approval
07/30/2013 CONCERTA
NDA #021121		 SUPPL-30 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Manufacturing (CMC) Approval
07/30/2013 MULTIHANCE
NDA #021357		 SUPPL-13 GADOBENATE DIMEGLUMINE BRACCO Labeling Approval
07/30/2013 MULTIHANCE MULTIPACK
NDA #021358		 SUPPL-12 GADOBENATE DIMEGLUMINE BRACCO Labeling Approval
07/30/2013 ABILIFY
NDA #021436		 SUPPL-37 ARIPIPRAZOLE OTSUKA Labeling Approval
07/30/2013 ABILIFY
NDA #021713		 SUPPL-29 ARIPIPRAZOLE OTSUKA Labeling Approval
07/30/2013 ABILIFY
NDA #021729		 SUPPL-21 ARIPIPRAZOLE OTSUKA Labeling Approval
07/30/2013 ABILIFY
NDA #021866		 SUPPL-22 ARIPIPRAZOLE OTSUKA Labeling Approval
07/30/2013 BUPIVACAINE HYDROCHLORIDE
NDA #022046		 SUPPL-5 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
07/30/2013 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
NDA #022046		 SUPPL-5 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
07/30/2013 DULERA
NDA #022518		 SUPPL-11 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
07/30/2013 CARISOPRODOL AND ASPIRIN
ANDA #040116		 SUPPL-12 ASPIRIN; CARISOPRODOL GENUS Labeling Approval
07/30/2013 CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
ANDA #040118		 SUPPL-13 ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE SANDOZ Labeling Approval
07/30/2013 CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
ANDA #040118		 SUPPL-14 ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE SANDOZ Labeling Approval
07/30/2013 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #062373		 SUPPL-35 GENTAMICIN SULFATE BAXTER HLTHCARE Labeling Approval
07/30/2013 CEFAZOLIN SODIUM
ANDA #065141		 SUPPL-3 CEFAZOLIN SODIUM SAMSON MEDCL Labeling Approval
07/30/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #071611		 SUPPL-70 CYCLOBENZAPRINE HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
07/30/2013 TRAZODONE HYDROCHLORIDE
ANDA #073137		 SUPPL-32 TRAZODONE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/30/2013 NATEGLINIDE
ANDA #077462		 SUPPL-1 NATEGLINIDE WATSON LABS Labeling Approval
07/30/2013 NATEGLINIDE
ANDA #077463		 SUPPL-1 NATEGLINIDE STRIDES PHARMA INTL Labeling Approval
07/30/2013 NATEGLINIDE
ANDA #077463		 SUPPL-5 NATEGLINIDE STRIDES PHARMA INTL Labeling Approval
07/30/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087006		 SUPPL-27 ACETAMINOPHEN; CODEINE PHOSPHATE PHARMOBEDIENT Labeling Approval
07/30/2013 FLUTICASONE PROPIONATE
ANDA #091553		 ORIG-1 FLUTICASONE PROPIONATE PADAGIS ISRAEL Approval
07/30/2013 LISINOPRIL
ANDA #202554		 ORIG-1 LISINOPRIL ACCORD HLTHCARE Approval
07/31/2013 AMINOSYN 10%
NDA #017673		 SUPPL-89 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 10% (PH6)
NDA #017673		 SUPPL-89 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 5%
NDA #017673		 SUPPL-89 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 7%
NDA #017673		 SUPPL-89 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 7% (PH6)
NDA #017673		 SUPPL-89 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 8.5%
NDA #017673		 SUPPL-89 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 8.5% (PH6)
NDA #017673		 SUPPL-89 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 8.5% W/ ELECTROLYTES
NDA #017673		 SUPPL-89 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN 8.5% W/ELECTROLYTES
NDA #017673		 SUPPL-89 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 PARLODEL
NDA #017962		 SUPPL-71 BROMOCRIPTINE MESYLATE ESJAY PHARMA Manufacturing (CMC) Approval
07/31/2013 DEPAKENE
NDA #018081		 SUPPL-56 VALPROIC ACID ABBVIE Labeling Approval
07/31/2013 DEPAKENE
NDA #018082		 SUPPL-39 VALPROIC ACID ABBVIE Labeling Approval
07/31/2013 DEPAKOTE
NDA #018723		 SUPPL-48 DIVALPROEX SODIUM ABBVIE Labeling Approval
07/31/2013 AMINOSYN II 10% W/ ELECTROLYTES
NDA #019437		 SUPPL-34 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN II 3.5% M
NDA #019437		 SUPPL-34 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN II 7% W/ ELECTROLYTES
NDA #019437		 SUPPL-34 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN II 8.5% W/ ELECTROLYTES
NDA #019437		 SUPPL-34 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 AMINOSYN II 8.5% W/ELECTROLYTES
NDA #019437		 SUPPL-34 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/2013 DEPAKOTE
NDA #019680		 SUPPL-35 DIVALPROEX SODIUM ABBVIE Labeling Approval
07/31/2013 CEREZYME
BLA #020367		 SUPPL-88 IMIGLUCERASE GENZYME Approval
07/31/2013 DEPACON
NDA #020593		 SUPPL-26 VALPROATE SODIUM ABBVIE Labeling Approval
07/31/2013 DEPAKOTE ER
NDA #021168		 SUPPL-24 DIVALPROEX SODIUM ABBVIE Labeling Approval
07/31/2013 CADUET
NDA #021540		 SUPPL-29 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Manufacturing (CMC) Approval
07/31/2013 ZIDOVUDINE
NDA #022294		 SUPPL-3 ZIDOVUDINE AUROBINDO PHARMA Manufacturing (CMC) Approval
07/31/2013 GRALISE
NDA #022544		 SUPPL-19 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
07/31/2013 AMPICILLIN SODIUM
ANDA #062738		 SUPPL-17 AMPICILLIN SODIUM SANDOZ Labeling Approval
07/31/2013 AMPICILLIN AND SULBACTAM
ANDA #065240		 SUPPL-11 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
07/31/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065373		 SUPPL-3 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
07/31/2013 VANCOMYCIN HYDROCHLORIDE
ANDA #065453		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
07/31/2013 OXYBUTYNIN CHLORIDE
ANDA #074625		 SUPPL-23 OXYBUTYNIN CHLORIDE AIPING PHARM INC Labeling Approval
07/31/2013 HALOPERIDOL
ANDA #076464		 SUPPL-2 HALOPERIDOL LACTATE FOSUN PHARMA Labeling Approval
07/31/2013 GLIPIZIDE
ANDA #076467		 SUPPL-17 GLIPIZIDE WATSON LABS Labeling Approval
07/31/2013 GLIMEPIRIDE
ANDA #076802		 SUPPL-15 GLIMEPIRIDE SENORES PHARMS Labeling Approval
07/31/2013 CLOZAPINE
ANDA #076809		 SUPPL-26 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
07/31/2013 ZIDOVUDINE
ANDA #077981		 SUPPL-14 ZIDOVUDINE CIPLA LTD Labeling Approval
07/31/2013 ESCITALOPRAM OXALATE
ANDA #078169		 SUPPL-2 ESCITALOPRAM OXALATE CHARTWELL RX Labeling Approval
07/31/2013 IBUPROFEN
ANDA #078682		 SUPPL-12 IBUPROFEN BIONPHARMA Labeling Approval
07/31/2013 IMIQUIMOD
ANDA #078837		 SUPPL-2 IMIQUIMOD PADAGIS ISRAEL Labeling Approval
07/31/2013 IBUPROFEN
ANDA #079205		 SUPPL-2 IBUPROFEN MARKSANS PHARMA Labeling Approval
07/31/2013 MEFENAMIC ACID
ANDA #090359		 SUPPL-1 MEFENAMIC ACID MPP PHARMA Labeling Approval
07/31/2013 LEVOFLOXACIN
ANDA #090787		 SUPPL-2 LEVOFLOXACIN APOTEX INC Labeling Approval
07/31/2013 ESCITALOPRAM OXALATE
ANDA #090939		 SUPPL-2 ESCITALOPRAM OXALATE TORRENT PHARMS LTD Labeling Approval
07/31/2013 LANSOPRAZOLE
ANDA #091269		 SUPPL-5 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
07/31/2013 TROSPIUM CHLORIDE
ANDA #091575		 SUPPL-7 TROSPIUM CHLORIDE GLENMARK PHARMS LTD Labeling Approval
07/31/2013 GADAVIST
NDA #201277		 SUPPL-2 GADOBUTROL BAYER HLTHCARE Manufacturing (CMC) Approval
07/31/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202164		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
07/31/2013 ESCITALOPRAM OXALATE
ANDA #202280		 SUPPL-3 ESCITALOPRAM OXALATE JUBILANT CADISTA Labeling Approval
07/31/2013 SUBSYS
NDA #202788		 SUPPL-5 FENTANYL BTCP PHARMA Labeling Approval
07/31/2013 SUBSYS
NDA #202788		 SUPPL-6 FENTANYL BTCP PHARMA Labeling Approval
07/31/2013 DEXTROAMPHETAMINE SULFATE
ANDA #202893		 ORIG-1 DEXTROAMPHETAMINE SULFATE AUROLIFE PHARMA LLC Approval
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