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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 2014

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 October 09, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/02/2014 LOVASTATIN
ANDA #075451		 SUPPL-23 LOVASTATIN AUROBINDO PHARMA USA Labeling Approval
11/02/2014 LOVASTATIN
ANDA #075551		 SUPPL-24 LOVASTATIN TEVA Labeling Approval
11/02/2014 LOVASTATIN
ANDA #075636		 SUPPL-27 LOVASTATIN EPIC PHARMA LLC Labeling Approval
11/02/2014 LOVASTATIN
ANDA #075828		 SUPPL-34 LOVASTATIN ACTAVIS ELIZABETH Labeling Approval
11/02/2014 NAPROXEN
ANDA #075927		 SUPPL-21 NAPROXEN AMNEAL PHARMS NY Labeling Approval
11/02/2014 PRAVASTATIN SODIUM
ANDA #076939		 SUPPL-12 PRAVASTATIN SODIUM WATSON LABS Labeling Approval
11/02/2014 PRAVASTATIN SODIUM
ANDA #077491		 SUPPL-2 PRAVASTATIN SODIUM SENORES PHARMS Labeling Approval
11/02/2014 LOVASTATIN
ANDA #077520		 SUPPL-10 LOVASTATIN SUN PHARM INDUSTRIES Labeling Approval
11/02/2014 LOVASTATIN
ANDA #077748		 SUPPL-3 LOVASTATIN COREPHARMA Labeling Approval
11/02/2014 LOVASTATIN
ANDA #077748		 SUPPL-4 LOVASTATIN COREPHARMA Labeling Approval
11/02/2014 RISPERIDONE
ANDA #078516		 SUPPL-8 RISPERIDONE ZYDUS PHARMS USA Labeling Approval
11/02/2014 CARBIDOPA, LEVODOPA AND ENTACAPONE
ANDA #090786		 SUPPL-1 CARBIDOPA; ENTACAPONE; LEVODOPA WOCKHARDT LTD Labeling Approval
11/02/2014 CARBIDOPA, LEVODOPA AND ENTACAPONE
ANDA #090833		 SUPPL-1 CARBIDOPA; ENTACAPONE; LEVODOPA WOCKHARDT LTD Labeling Approval
11/03/2014 FURADANTIN
NDA #009175		 SUPPL-43 NITROFURANTOIN CASPER PHARMA LLC Manufacturing (CMC) Approval
11/03/2014 LEVITRA
NDA #021400		 SUPPL-18 VARDENAFIL HYDROCHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
11/03/2014 LUNESTA
NDA #021476		 SUPPL-31 ESZOPICLONE WAYLIS THERAP Manufacturing (CMC) Approval
11/03/2014 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444		 SUPPL-6 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Manufacturing (CMC) Approval
11/03/2014 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444		 SUPPL-7 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Labeling Approval
11/03/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065191		 SUPPL-13 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
11/03/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065191		 SUPPL-14 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
11/03/2014 ATENOLOL
ANDA #073026		 SUPPL-41 ATENOLOL PHARMOBEDIENT Labeling Approval
11/03/2014 CAPTOPRIL
ANDA #074505		 SUPPL-22 CAPTOPRIL HIKMA INTL PHARMS Labeling Approval
11/03/2014 CAPTOPRIL
ANDA #074505		 SUPPL-23 CAPTOPRIL HIKMA INTL PHARMS Labeling Approval
11/03/2014 ENALAPRIL MALEATE
ANDA #075657		 SUPPL-11 ENALAPRIL MALEATE TARO Labeling Approval
11/03/2014 GABAPENTIN
ANDA #075694		 SUPPL-31 GABAPENTIN ACTAVIS ELIZABETH Labeling Approval
11/03/2014 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075727		 SUPPL-18 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE COSETTE PHARMS NC Labeling Approval
11/03/2014 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075727		 SUPPL-19 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE COSETTE PHARMS NC Labeling Approval
11/03/2014 CLOPIDOGREL BISULFATE
ANDA #076274		 SUPPL-5 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/03/2014 IBUPROFEN
ANDA #076460		 SUPPL-6 IBUPROFEN AVEMA PHARMA Labeling Approval
11/03/2014 PRAVASTATIN SODIUM
ANDA #076714		 SUPPL-7 PRAVASTATIN SODIUM DR REDDYS LABS INC Labeling Approval
11/03/2014 NICOTINE POLACRILEX
ANDA #077007		 SUPPL-23 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
11/03/2014 CITALOPRAM HYDROBROMIDE
ANDA #077289		 SUPPL-15 CITALOPRAM HYDROBROMIDE AMNEAL PHARMS NY Labeling Approval
11/03/2014 CITALOPRAM HYDROBROMIDE
ANDA #077289		 SUPPL-18 CITALOPRAM HYDROBROMIDE AMNEAL PHARMS NY Labeling Approval
11/03/2014 CITALOPRAM HYDROBROMIDE
ANDA #077289		 SUPPL-19 CITALOPRAM HYDROBROMIDE AMNEAL PHARMS NY Labeling Approval
11/03/2014 SIMVASTATIN
ANDA #077752		 SUPPL-20 SIMVASTATIN RISING Labeling Approval
11/03/2014 SIMVASTATIN
ANDA #077752		 SUPPL-21 SIMVASTATIN RISING Labeling Approval
11/03/2014 SIMVASTATIN
ANDA #077837		 SUPPL-29 SIMVASTATIN ZYDUS PHARMS USA Labeling Approval
11/03/2014 SIMVASTATIN
ANDA #077837		 SUPPL-30 SIMVASTATIN ZYDUS PHARMS USA Labeling Approval
11/03/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077890		 SUPPL-7 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE WATSON LABS Labeling Approval
11/03/2014 PRAVASTATIN SODIUM
ANDA #077917		 SUPPL-16 PRAVASTATIN SODIUM CHARTWELL RX Manufacturing (CMC) Approval
11/03/2014 GLIMEPIRIDE
ANDA #078181		 SUPPL-7 GLIMEPIRIDE ACCORD HLTHCARE Labeling Approval
11/03/2014 FLUOXETINE HYDROCHLORIDE
ANDA #078572		 SUPPL-4 FLUOXETINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
11/03/2014 FLUOXETINE HYDROCHLORIDE
ANDA #078572		 SUPPL-5 FLUOXETINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
11/03/2014 FLUOXETINE HYDROCHLORIDE
ANDA #078572		 SUPPL-6 FLUOXETINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
11/03/2014 DONEPEZIL HYDROCHLORIDE
ANDA #078841		 SUPPL-4 DONEPEZIL HYDROCHLORIDE APOTEX Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #079063		 SUPPL-8 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #079063		 SUPPL-10 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #079063		 SUPPL-13 LEVETIRACETAM AUROBINDO PHARMA Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #079107		 SUPPL-10 LEVETIRACETAM TOLMAR Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #079107		 SUPPL-12 LEVETIRACETAM TOLMAR Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #079107		 SUPPL-15 LEVETIRACETAM TOLMAR Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #079107		 SUPPL-18 LEVETIRACETAM TOLMAR Labeling Approval
11/03/2014 DONEPEZIL HYDROCHLORIDE
ANDA #090290		 SUPPL-7 DONEPEZIL HYDROCHLORIDE AIPING PHARM INC Labeling Approval
11/03/2014 DONEPEZIL HYDROCHLORIDE
ANDA #090425		 SUPPL-3 DONEPEZIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
11/03/2014 FINASTERIDE
ANDA #090508		 SUPPL-3 FINASTERIDE SUN PHARM Labeling Approval
11/03/2014 FENOFIBRATE
ANDA #090856		 SUPPL-3 FENOFIBRATE LUPIN LTD Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #090893		 SUPPL-1 LEVETIRACETAM LUPIN LTD Labeling Approval
11/03/2014 LEVETIRACETAM
ANDA #090893		 SUPPL-6 LEVETIRACETAM LUPIN LTD Labeling Approval
11/03/2014 DOXORUBICIN HYDROCHLORIDE
ANDA #091495		 SUPPL-1 DOXORUBICIN HYDROCHLORIDE SAGENT PHARMS Labeling Approval
11/03/2014 DOXORUBICIN HYDROCHLORIDE
ANDA #200170		 SUPPL-2 DOXORUBICIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
11/03/2014 MARQIBO KIT
NDA #202497		 SUPPL-3 VINCRISTINE SULFATE ACROTECH Manufacturing (CMC) Approval
11/03/2014 KYPROLIS
NDA #202714		 SUPPL-5 CARFILZOMIB ONYX PHARMS AMGEN Manufacturing (CMC) Approval
11/03/2014 NORTHERA
NDA #203202		 SUPPL-1 DROXIDOPA LUNDBECK NA LTD Manufacturing (CMC) Approval
11/03/2014 NORTHERA
NDA #203202		 SUPPL-3 DROXIDOPA LUNDBECK NA LTD Manufacturing (CMC) Approval
11/03/2014 TELMISARTAN
ANDA #203867		 ORIG-1 TELMISARTAN SANDOZ Approval
11/04/2014 ABSTRAL
NDA #022510		 SUPPL-13 FENTANYL CITRATE SENTYNL THERAPS INC Labeling Approval
11/04/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065096		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Manufacturing (CMC) Approval
11/04/2014 CARBIDOPA AND LEVODOPA
ANDA #074260		 SUPPL-33 CARBIDOPA; LEVODOPA ACTAVIS ELIZABETH Manufacturing (CMC) Approval
11/04/2014 FAMOTIDINE
ANDA #075610		 SUPPL-6 FAMOTIDINE APOTEX Manufacturing (CMC) Approval
11/04/2014 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075788		 SUPPL-7 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TARO PHARM INDS Labeling Approval
11/04/2014 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075788		 SUPPL-8 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TARO PHARM INDS Labeling Approval
11/04/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077375		 SUPPL-4 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE RISING Labeling Approval
11/04/2014 ATENOLOL
ANDA #077443		 SUPPL-5 ATENOLOL UNIQUE Labeling Approval
11/04/2014 GRANISETRON HYDROCHLORIDE
ANDA #077842		 SUPPL-3 GRANISETRON HYDROCHLORIDE HIKMA PHARMS Manufacturing (CMC) Approval
11/04/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #079047		 SUPPL-3 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
11/04/2014 ESCITALOPRAM OXALATE
ANDA #079121		 SUPPL-6 ESCITALOPRAM OXALATE SUN PHARMA CANADA Labeling Approval
11/04/2014 SIMVASTATIN
ANDA #090383		 SUPPL-2 SIMVASTATIN MICRO LABS Labeling Approval
11/04/2014 SIMVASTATIN
ANDA #090383		 SUPPL-3 SIMVASTATIN MICRO LABS Labeling Approval
11/04/2014 DOXYCYCLINE HYCLATE
ANDA #091052		 SUPPL-3 DOXYCYCLINE HYCLATE AUROBINDO PHARMA USA Labeling Approval
11/04/2014 LEVETIRACETAM
ANDA #091338		 SUPPL-5 LEVETIRACETAM TORRENT PHARMS LTD Labeling Approval
11/04/2014 LEVETIRACETAM
ANDA #091338		 SUPPL-6 LEVETIRACETAM TORRENT PHARMS LTD Labeling Approval
11/04/2014 VALGANCICLOVIR HYDROCHLORIDE
ANDA #200790		 ORIG-1 VALGANCICLOVIR HYDROCHLORIDE STRIDES PHARMA INTL Approval
11/04/2014 DOCETAXEL
NDA #201525		 SUPPL-8 DOCETAXEL SANDOZ Labeling Approval
11/04/2014 DOCETAXEL
NDA #201525		 SUPPL-9 DOCETAXEL SANDOZ Labeling Approval
11/04/2014 LOSARTAN POTASSIUM
ANDA #202230		 SUPPL-3 LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
11/04/2014 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #202289		 SUPPL-4 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
11/04/2014 ATORVASTATIN CALCIUM
ANDA #202357		 SUPPL-4 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
11/04/2014 VALGANCICLOVIR HYDROCHLORIDE
ANDA #203511		 ORIG-1 VALGANCICLOVIR HYDROCHLORIDE DR REDDYS Approval
11/05/2014 LOPID
NDA #018422		 SUPPL-54 GEMFIBROZIL PFIZER PHARMS Labeling Approval
11/05/2014 PROTONIX IV
NDA #020988		 SUPPL-51 PANTOPRAZOLE SODIUM WYETH PHARMS Manufacturing (CMC) Approval
11/05/2014 LEVOXYL
NDA #021301		 SUPPL-37 LEVOTHYROXINE SODIUM KING PHARMS Manufacturing (CMC) Approval
11/05/2014 SEASONALE
NDA #021544		 SUPPL-12 ETHINYL ESTRADIOL; LEVONORGESTREL TEVA BRANDED PHARM Manufacturing (CMC) Approval
11/05/2014 ZITHROMAX
NDA #050693		 SUPPL-25 AZITHROMYCIN PFIZER Manufacturing (CMC) Approval
11/05/2014 DOXORUBICIN HYDROCHLORIDE
ANDA #063277		 SUPPL-20 DOXORUBICIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/05/2014 KETOCONAZOLE
ANDA #075597		 SUPPL-5 KETOCONAZOLE AUROBINDO PHARMA USA Manufacturing (CMC) Approval
11/05/2014 SIMVASTATIN
ANDA #076052		 SUPPL-38 SIMVASTATIN IVAX SUB TEVA PHARMS Labeling Approval
11/05/2014 SIMVASTATIN
ANDA #076052		 SUPPL-39 SIMVASTATIN IVAX SUB TEVA PHARMS Labeling Approval
11/05/2014 RISEDRONATE SODIUM
ANDA #077132		 SUPPL-4 RISEDRONATE SODIUM TEVA PHARMS USA Labeling Approval
11/05/2014 METHADONE HYDROCHLORIDE
ANDA #077142		 SUPPL-8 METHADONE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
11/05/2014 SIMVASTATIN
ANDA #077691		 SUPPL-26 SIMVASTATIN AUROBINDO PHARMA Labeling Approval
11/05/2014 SIMVASTATIN
ANDA #077691		 SUPPL-28 SIMVASTATIN AUROBINDO PHARMA Labeling Approval
11/05/2014 SIMVASTATIN
ANDA #078034		 SUPPL-7 SIMVASTATIN BIOCON PHARMA Labeling Approval
11/05/2014 SIMVASTATIN
ANDA #078034		 SUPPL-8 SIMVASTATIN BIOCON PHARMA Labeling Approval
11/05/2014 SIMVASTATIN
ANDA #078103		 SUPPL-31 SIMVASTATIN LUPIN Labeling Approval
11/05/2014 SIMVASTATIN
ANDA #078155		 SUPPL-18 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
11/05/2014 SIMVASTATIN
ANDA #078155		 SUPPL-20 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
11/05/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #078466		 SUPPL-9 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE LUPIN PHARMS Labeling Approval
11/05/2014 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
ANDA #078466		 SUPPL-9 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE LUPIN PHARMS Labeling Approval
11/05/2014 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #078862		 SUPPL-3 CETIRIZINE HYDROCHLORIDE ORBION PHARMS Labeling Approval
11/05/2014 CETIRIZINE HYDROCHLORIDE HIVES
ANDA #078862		 SUPPL-3 CETIRIZINE HYDROCHLORIDE ORBION PHARMS Labeling Approval
11/05/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #090364		 SUPPL-6 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE WATSON LABS INC Labeling Approval
11/05/2014 LOSARTAN POTASSIUM
ANDA #090790		 SUPPL-5 LOSARTAN POTASSIUM APOTEX CORP Labeling Approval
11/05/2014 LOSARTAN POTASSIUM
ANDA #090790		 SUPPL-6 LOSARTAN POTASSIUM APOTEX CORP Labeling Approval
11/05/2014 TRAMADOL HYDROCHLORIDE
ANDA #091498		 SUPPL-1 TRAMADOL HYDROCHLORIDE CSPC OUYI PHARM CO Manufacturing (CMC) Approval
11/05/2014 LOSARTAN POTASSIUM
ANDA #091541		 SUPPL-3 LOSARTAN POTASSIUM MICRO LABS Labeling Approval
11/05/2014 ATORVASTATIN CALCIUM
ANDA #091650		 SUPPL-5 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
11/05/2014 CYRAMZA
BLA #125477		 SUPPL-2 RAMUCIRUMAB ELI LILLY AND CO Approval
11/05/2014 LOSARTAN POTASSIUM
ANDA #200290		 SUPPL-1 LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
11/05/2014 DOXORUBICIN HYDROCHLORIDE
ANDA #200901		 SUPPL-2 DOXORUBICIN HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
11/05/2014 MODAFINIL
ANDA #202566		 SUPPL-3 MODAFINIL AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
11/05/2014 DOCETAXEL
ANDA #204193		 ORIG-1 DOCETAXEL DR REDDYS Approval
11/05/2014 PENNSAID
NDA #204623		 SUPPL-3 DICLOFENAC SODIUM HORIZON Labeling Approval
11/05/2014 OLYSIO
NDA #205123		 SUPPL-2 SIMEPREVIR SODIUM JANSSEN PRODS Efficacy Approval
11/05/2014 CERDELGA
NDA #205494		 SUPPL-1 ELIGLUSTAT TARTRATE GENZYME CORP Manufacturing (CMC) Approval
11/06/2014 CILOSTAZOL
ANDA #077027		 SUPPL-8 CILOSTAZOL TEVA Manufacturing (CMC) Approval
11/06/2014 QUETIAPINE FUMARATE
ANDA #077745		 SUPPL-6 QUETIAPINE FUMARATE TEVA PHARMS Manufacturing (CMC) Approval
11/06/2014 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #091281		 SUPPL-2 CYCLOBENZAPRINE HYDROCHLORIDE TWI PHARMS INC Manufacturing (CMC) Approval
11/06/2014 HUMIRA
BLA #125057		 SUPPL-390 ADALIMUMAB ABBVIE INC Approval
11/06/2014 DONEPEZIL HYDROCHLORIDE
ANDA #201146		 SUPPL-3 DONEPEZIL HYDROCHLORIDE MACLEODS PHARMS LTD Manufacturing (CMC) Approval
11/07/2014 FOSCAVIR
NDA #020068		 SUPPL-20 FOSCARNET SODIUM CLINIGEN HLTHCARE Labeling Approval
11/07/2014 SUCRAID
BLA #020772		 SUPPL-15 SACROSIDASE QOL MEDCL Approval
11/07/2014 IPRIVASK
BLA #021271		 SUPPL-6 DESIRUDIN RECOMBINANT BAUSCH Approval
11/07/2014 CEFTRIAXONE
ANDA #065329		 SUPPL-7 CEFTRIAXONE SODIUM ACS DOBFAR Labeling Approval
11/07/2014 DICLOFENAC SODIUM
ANDA #074514		 SUPPL-30 DICLOFENAC SODIUM ACTAVIS ELIZABETH Labeling Approval
11/07/2014 LORATADINE
ANDA #077421		 SUPPL-8 LORATADINE LANNETT CO INC Manufacturing (CMC) Approval
11/07/2014 ATENOLOL
ANDA #077877		 SUPPL-13 ATENOLOL IPCA LABS LTD Labeling Approval
11/07/2014 PROPOFOL
ANDA #077908		 SUPPL-23 PROPOFOL HOSPIRA Manufacturing (CMC) Approval
11/07/2014 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #078862		 SUPPL-2 CETIRIZINE HYDROCHLORIDE ORBION PHARMS Manufacturing (CMC) Approval
11/07/2014 CETIRIZINE HYDROCHLORIDE HIVES
ANDA #078862		 SUPPL-2 CETIRIZINE HYDROCHLORIDE ORBION PHARMS Manufacturing (CMC) Approval
11/07/2014 VANCOMYCIN HYDROCHLORIDE
ANDA #091554		 SUPPL-5 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
11/07/2014 SERTRALINE HYDROCHLORIDE
ANDA #202825		 ORIG-1 SERTRALINE HYDROCHLORIDE ACCORD HLTHCARE Approval
11/07/2014 BELSOMRA
NDA #204569		 SUPPL-1 SUVOREXANT MERCK SHARP DOHME Labeling Approval
11/07/2014 OTREXUP
NDA #204824		 SUPPL-3 METHOTREXATE COSETTE Manufacturing (CMC) Approval
11/07/2014 OTREXUP PFS
NDA #204824		 SUPPL-3 METHOTREXATE COSETTE Manufacturing (CMC) Approval
11/08/2014 LEVOFLOXACIN
ANDA #078424		 SUPPL-10 LEVOFLOXACIN LUPIN Labeling Approval
11/08/2014 LEVOFLOXACIN
ANDA #078424		 SUPPL-11 LEVOFLOXACIN LUPIN Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078597		 SUPPL-12 DIVALPROEX SODIUM SUN PHARM INDS Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078597		 SUPPL-13 DIVALPROEX SODIUM SUN PHARM INDS Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078705		 SUPPL-5 DIVALPROEX SODIUM SCIEGEN PHARMS Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078705		 SUPPL-6 DIVALPROEX SODIUM SCIEGEN PHARMS Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078755		 SUPPL-3 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
11/08/2014 GABAPENTIN
ANDA #078787		 SUPPL-10 GABAPENTIN AUROBINDO PHARMA Labeling Approval
11/08/2014 GABAPENTIN
ANDA #078787		 SUPPL-14 GABAPENTIN AUROBINDO PHARMA Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078790		 SUPPL-12 DIVALPROEX SODIUM LUPIN Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078790		 SUPPL-13 DIVALPROEX SODIUM LUPIN Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078790		 SUPPL-14 DIVALPROEX SODIUM LUPIN Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-10 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-11 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/08/2014 GABAPENTIN
ANDA #078926		 SUPPL-5 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
11/08/2014 GABAPENTIN
ANDA #078926		 SUPPL-7 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-9 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-10 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
11/08/2014 GABAPENTIN
ANDA #090007		 SUPPL-2 GABAPENTIN MARKSANS PHARMA Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #090062		 SUPPL-4 DIVALPROEX SODIUM PHARMOBEDIENT Labeling Approval
11/08/2014 DIVALPROEX SODIUM
ANDA #090062		 SUPPL-5 DIVALPROEX SODIUM PHARMOBEDIENT Labeling Approval
11/08/2014 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #090343		 SUPPL-16 LEVOFLOXACIN INFORLIFE Labeling Approval
11/08/2014 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #090343		 SUPPL-18 LEVOFLOXACIN INFORLIFE Labeling Approval
11/08/2014 LEVOFLOXACIN
ANDA #090722		 SUPPL-7 LEVOFLOXACIN TORRENT PHARMS Labeling Approval
11/08/2014 LEVOFLOXACIN
ANDA #090722		 SUPPL-8 LEVOFLOXACIN TORRENT PHARMS Labeling Approval
11/08/2014 GABAPENTIN
ANDA #090858		 SUPPL-4 GABAPENTIN ALKEM Labeling Approval
11/08/2014 GABAPENTIN
ANDA #202024		 SUPPL-1 GABAPENTIN AMNEAL PHARMS Labeling Approval
11/08/2014 GABAPENTIN
ANDA #202024		 SUPPL-2 GABAPENTIN AMNEAL PHARMS Labeling Approval
11/09/2014 DIVALPROEX SODIUM
ANDA #079163		 SUPPL-6 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
11/10/2014 HUMATROPE
BLA #019640		 SUPPL-98 SOMATROPIN LILLY Approval
11/10/2014 TRI-LUMA
NDA #021112		 SUPPL-10 FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN GALDERMA LABS LP Manufacturing (CMC) Approval
11/10/2014 VENTAVIS
NDA #021779		 SUPPL-15 ILOPROST ACTELION Manufacturing (CMC) Approval
11/10/2014 FIRMAGON
NDA #022201		 SUPPL-6 DEGARELIX ACETATE FERRING Manufacturing (CMC) Approval
11/10/2014 CAYSTON
NDA #050814		 SUPPL-14 AZTREONAM GILEAD Manufacturing (CMC) Approval
11/10/2014 CHLORAMPHENICOL SODIUM SUCCINATE
ANDA #062365		 SUPPL-19 CHLORAMPHENICOL SODIUM SUCCINATE FRESENIUS KABI USA Manufacturing (CMC) Approval
11/10/2014 SERTRALINE HYDROCHLORIDE
ANDA #077162		 SUPPL-4 SERTRALINE HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
11/10/2014 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #077909		 SUPPL-3 FLUCONAZOLE WOODWARD Labeling Approval
11/10/2014 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #077909		 SUPPL-4 FLUCONAZOLE WOODWARD Labeling Approval
11/10/2014 FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
ANDA #077947		 SUPPL-2 FLUCONAZOLE BAXTER HLTHCARE CORP Labeling Approval
11/10/2014 FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
ANDA #077947		 SUPPL-3 FLUCONAZOLE BAXTER HLTHCARE CORP Labeling Approval
11/10/2014 FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #077988		 SUPPL-2 FLUCONAZOLE WOODWARD Labeling Approval
11/10/2014 FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #077988		 SUPPL-3 FLUCONAZOLE WOODWARD Labeling Approval
11/10/2014 TRIAMCINOLONE ACETONIDE
ANDA #088450		 SUPPL-13 TRIAMCINOLONE ACETONIDE PHARMOBEDIENT Manufacturing (CMC) Approval
11/10/2014 TRIAMCINOLONE ACETONIDE
ANDA #088451		 SUPPL-13 TRIAMCINOLONE ACETONIDE PHARMOBEDIENT Manufacturing (CMC) Approval
11/10/2014 MEROPENEM
ANDA #091404		 SUPPL-7 MEROPENEM ACS DOBFAR Manufacturing (CMC) Approval
11/10/2014 GUANFACINE HYDROCHLORIDE
ANDA #200881		 SUPPL-3 GUANFACINE HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
11/10/2014 STIVARGA
NDA #203085		 SUPPL-2 REGORAFENIB BAYER HLTHCARE Manufacturing (CMC) Approval
11/10/2014 KALYDECO
NDA #203188		 SUPPL-12 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
11/10/2014 MINIVELLE
NDA #203752		 SUPPL-6 ESTRADIOL NOVEN Manufacturing (CMC) Approval
11/11/2014 AQUASOL A
NDA #006823		 SUPPL-18 VITAMIN A PALMITATE CASPER PHARMA LLC Manufacturing (CMC) Approval
11/11/2014 PRECOSE
NDA #020482		 SUPPL-26 ACARBOSE BAYER HLTHCARE Manufacturing (CMC) Approval
11/11/2014 HUMALOG
BLA #020563		 SUPPL-155 INSULIN LISPRO RECOMBINANT LILLY Approval
11/11/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-155 INSULIN LISPRO RECOMBINANT LILLY Approval
11/11/2014 HUMALOG PEN
BLA #020563		 SUPPL-155 INSULIN LISPRO RECOMBINANT LILLY Approval
11/11/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-155 INSULIN LISPRO RECOMBINANT LILLY Approval
11/11/2014 INFUVITE PEDIATRIC
NDA #021265		 SUPPL-26 ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K SANDOZ CANADA INC Manufacturing (CMC) Approval
11/11/2014 INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
NDA #021265		 SUPPL-26 ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K SANDOZ CANADA INC Manufacturing (CMC) Approval
11/11/2014 JUXTAPID
NDA #203858		 SUPPL-8 LOMITAPIDE MESYLATE CHIESI Manufacturing (CMC) Approval
11/11/2014 OMTRYG
NDA #204977		 SUPPL-2 OMEGA-3-ACID ETHYL ESTERS TYPE A OSMOTICA PHARM US Manufacturing (CMC) Approval
11/12/2014 ANDROGEL
NDA #021015		 SUPPL-38 TESTOSTERONE BESINS HLTHCARE Labeling Approval
11/12/2014 VIBATIV
NDA #022110		 SUPPL-10 TELAVANCIN HYDROCHLORIDE APOTEX REMS Approval
11/12/2014 INVEGA SUSTENNA
NDA #022264		 SUPPL-13 PALIPERIDONE PALMITATE JANSSEN PHARMS Efficacy Approval
11/12/2014 INVEGA SUSTENNA
NDA #022264		 SUPPL-14 PALIPERIDONE PALMITATE JANSSEN PHARMS Efficacy Approval
11/12/2014 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040119		 SUPPL-4 ACETAMINOPHEN; CODEINE PHOSPHATE PAI HOLDINGS Manufacturing (CMC) Approval
11/12/2014 CLINDAMYCIN HYDROCHLORIDE
ANDA #063083		 SUPPL-47 CLINDAMYCIN HYDROCHLORIDE WATSON LABS Manufacturing (CMC) Approval
11/12/2014 NAPROXEN SODIUM
ANDA #074661		 SUPPL-40 NAPROXEN SODIUM PERRIGO Labeling Approval
11/12/2014 ALPRAZOLAM
ANDA #077996		 SUPPL-4 ALPRAZOLAM IMPAX LABS INC Manufacturing (CMC) Approval
11/13/2014 FLOVENT DISKUS 100
NDA #020833		 SUPPL-30 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
11/13/2014 FLOVENT DISKUS 250
NDA #020833		 SUPPL-30 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
11/13/2014 FLOVENT DISKUS 50
NDA #020833		 SUPPL-30 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
11/13/2014 ADVAIR DISKUS 100/50
NDA #021077		 SUPPL-53 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
11/13/2014 ADVAIR DISKUS 250/50
NDA #021077		 SUPPL-53 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
11/13/2014 ADVAIR DISKUS 500/50
NDA #021077		 SUPPL-53 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
11/13/2014 ADVAIR HFA
NDA #021254		 SUPPL-23 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
11/13/2014 MYCOBUTIN
NDA #050689		 SUPPL-18 RIFABUTIN PFIZER Labeling Approval
11/13/2014 DESOXIMETASONE
ANDA #078369		 SUPPL-1 DESOXIMETASONE FOUGERA PHARMS Manufacturing (CMC) Approval
11/13/2014 ACTEMRA
BLA #125276		 SUPPL-105 TOCILIZUMAB GENENTECH Approval
11/13/2014 ZOLMITRIPTAN
ANDA #203476		 ORIG-1 ZOLMITRIPTAN SUN PHARMA GLOBAL Approval
11/14/2014 OMNISCAN
NDA #020123		 SUPPL-43 GADODIAMIDE GE HEALTHCARE Labeling Approval
11/14/2014 TAXOTERE
NDA #020449		 SUPPL-73 DOCETAXEL SANOFI AVENTIS US Labeling Approval
11/14/2014 ARAVA
NDA #020905		 SUPPL-28 LEFLUNOMIDE SANOFI AVENTIS US Labeling Approval
11/14/2014 PRECEDEX
NDA #021038		 SUPPL-19 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/14/2014 PRECEDEX
NDA #021038		 SUPPL-24 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
11/14/2014 PRECEDEX
NDA #021038		 SUPPL-26 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/14/2014 FLOVENT HFA
NDA #021433		 SUPPL-25 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
11/14/2014 VYVANSE
NDA #021977		 SUPPL-33 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
11/14/2014 OMNISCAN
NDA #022066		 SUPPL-7 GADODIAMIDE GE HEALTHCARE Labeling Approval
11/14/2014 ANDROGEL
NDA #022309		 SUPPL-11 TESTOSTERONE BESINS HLTHCARE Labeling Approval
11/14/2014 CLINDAMYCIN PHOSPHATE
ANDA #062811		 SUPPL-17 CLINDAMYCIN PHOSPHATE G AND W LABS INC Manufacturing (CMC) Approval
11/14/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075755		 SUPPL-19 FLUOXETINE HYDROCHLORIDE RISING Labeling Approval
11/14/2014 BUPROPION HYDROCHLORIDE
ANDA #077455		 SUPPL-24 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
11/14/2014 MELOXICAM
ANDA #077933		 SUPPL-2 MELOXICAM ZENNOVA Manufacturing (CMC) Approval
11/14/2014 TRIAMCINOLONE ACETONIDE
ANDA #078104		 SUPPL-3 TRIAMCINOLONE ACETONIDE PERRIGO PHARMA INTL Labeling Approval
11/14/2014 BICALUTAMIDE
ANDA #078575		 SUPPL-1 BICALUTAMIDE SANDOZ Manufacturing (CMC) Approval
11/14/2014 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #079112		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE PHARMAZONE Manufacturing (CMC) Approval
11/14/2014 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #079112		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE PHARMAZONE Manufacturing (CMC) Approval
11/14/2014 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #079112		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE PHARMAZONE Manufacturing (CMC) Approval
11/14/2014 FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #079112		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE PHARMAZONE Manufacturing (CMC) Approval
11/14/2014 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090011		 SUPPL-2 AMLODIPINE BESYLATE; VALSARTAN STRIDES PHARMA INTL Manufacturing (CMC) Approval
11/14/2014 CAMPATH
BLA #103948		 SUPPL-5139 ALEMTUZUMAB GENZYME Approval
11/14/2014 LEMTRADA
BLA #103948		 SUPPL-5139 ALEMTUZUMAB GENZYME Approval
11/14/2014 AVASTIN
BLA #125085		 SUPPL-305 BEVACIZUMAB GENENTECH Approval
11/14/2014 FYCOMPA
NDA #202834		 SUPPL-6 PERAMPANEL CATALYST PHARMS Labeling Approval
11/14/2014 MYCOPHENOLATE MOFETIL
ANDA #203005		 ORIG-1 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Approval
11/14/2014 TECFIDERA
NDA #204063		 SUPPL-9 DIMETHYL FUMARATE BIOGEN Labeling Approval
11/14/2014 SOVALDI
NDA #204671		 SUPPL-1 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
11/14/2014 OBREDON
NDA #205474		 ORIG-1 GUAIFENESIN; HYDROCODONE BITARTRATE SOVEREIGN PHARMS Type 4 - New Combination Approval
11/15/2014 AURYXIA
NDA #205874		 SUPPL-1 FERRIC CITRATE KERYX BIOPHARMS Labeling Approval
11/16/2014 RESECTISOL IN PLASTIC CONTAINER
NDA #016772		 SUPPL-34 MANNITOL B BRAUN Manufacturing (CMC) Approval
11/16/2014 FIORINAL W/CODEINE
NDA #019429		 SUPPL-37 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Manufacturing (CMC) Approval
11/16/2014 ZYTIGA
NDA #202379		 SUPPL-13 ABIRATERONE ACETATE JANSSEN BIOTECH Manufacturing (CMC) Approval
11/16/2014 CHOLINE C-11
NDA #203155		 SUPPL-33 CHOLINE C-11 MCPRF Manufacturing (CMC) Approval
11/16/2014 INJECTAFER
NDA #203565		 SUPPL-1 FERRIC CARBOXYMALTOSE AM REGENT Manufacturing (CMC) Approval
11/16/2014 MORPHINE SULFATE
NDA #204223		 SUPPL-3 MORPHINE SULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
11/17/2014 HEPATAMINE 8%
NDA #018676		 SUPPL-32 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/17/2014 CUTIVATE
NDA #021152		 SUPPL-8 FLUTICASONE PROPIONATE FOUGERA Manufacturing (CMC) Approval
11/17/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #040751		 SUPPL-1 IMIPRAMINE HYDROCHLORIDE OXFORD PHARMS Labeling Approval
11/17/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #040903		 SUPPL-4 IMIPRAMINE HYDROCHLORIDE LEADING Labeling Approval
11/17/2014 UNASYN
NDA #050608		 SUPPL-41 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Labeling Approval
11/17/2014 UNASYN
NDA #050608		 SUPPL-42 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Labeling Approval
11/17/2014 AMOXIL
ANDA #062216		 SUPPL-36 AMOXICILLIN US ANTIBIOTICS Labeling Approval
11/17/2014 AMOXIL
ANDA #062226		 SUPPL-37 AMOXICILLIN US ANTIBIOTICS Labeling Approval
11/17/2014 LAROTID
ANDA #062226		 SUPPL-37 AMOXICILLIN US ANTIBIOTICS Labeling Approval
11/17/2014 TRAZODONE HYDROCHLORIDE
ANDA #074357		 SUPPL-6 TRAZODONE HYDROCHLORIDE TEVA Labeling Approval
11/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075755		 SUPPL-21 FLUOXETINE HYDROCHLORIDE RISING Labeling Approval
11/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075810		 SUPPL-3 FLUOXETINE HYDROCHLORIDE BARR Labeling Approval
11/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075865		 SUPPL-12 FLUOXETINE HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
11/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-36 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-38 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-39 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/17/2014 NEFAZODONE HYDROCHLORIDE
ANDA #076302		 SUPPL-2 NEFAZODONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #076317		 SUPPL-7 TOPIRAMATE TEVA Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #076317		 SUPPL-8 TOPIRAMATE TEVA Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #076317		 SUPPL-9 TOPIRAMATE TEVA Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #076317		 SUPPL-10 TOPIRAMATE TEVA Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #076327		 SUPPL-1 TOPIRAMATE SUN PHARM INDS LTD Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #076327		 SUPPL-3 TOPIRAMATE SUN PHARM INDS LTD Labeling Approval
11/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #078627		 SUPPL-10 VENLAFAXINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #079206		 SUPPL-1 TOPIRAMATE CHARTWELL RX Labeling Approval
11/17/2014 TOPIRAMATE
ANDA #079206		 SUPPL-6 TOPIRAMATE CHARTWELL RX Labeling Approval
11/17/2014 TESTOPEL
ANDA #080911		 SUPPL-17 TESTOSTERONE ENDO OPERATIONS Labeling Approval
11/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085031		 SUPPL-286 AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS Labeling Approval
11/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085032		 SUPPL-308 AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS INC Labeling Approval
11/17/2014 LIDOCAINE VISCOUS
ANDA #088802		 SUPPL-23 LIDOCAINE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
11/17/2014 PEGINTRON
BLA #103949		 SUPPL-5293 PEGINTERFERON ALFA-2B SCHERING Approval
11/17/2014 SYLATRON
BLA #103949		 SUPPL-5293 PEGINTERFERON ALFA-2B SCHERING Approval
11/17/2014 NUCYNTA
NDA #203794		 SUPPL-2 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
11/17/2014 NUCYNTA
NDA #203794		 SUPPL-3 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
11/18/2014 SAPHRIS
NDA #022117		 SUPPL-14 ASENAPINE MALEATE ABBVIE Labeling Approval
11/18/2014 SAPHRIS
NDA #022117		 SUPPL-15 ASENAPINE MALEATE ABBVIE Labeling Approval
11/18/2014 SAPHRIS
NDA #022117		 SUPPL-16 ASENAPINE MALEATE ABBVIE Labeling Approval
11/18/2014 VOTRIENT
NDA #022465		 SUPPL-19 PAZOPANIB HYDROCHLORIDE NOVARTIS Efficacy Approval
11/18/2014 TOPIRAMATE
ANDA #076575		 SUPPL-4 TOPIRAMATE TEVA Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #076575		 SUPPL-5 TOPIRAMATE TEVA Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #076575		 SUPPL-6 TOPIRAMATE TEVA Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #076575		 SUPPL-7 TOPIRAMATE TEVA Labeling Approval
11/18/2014 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #076667		 ORIG-1 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS Approval
11/18/2014 TOPIRAMATE
ANDA #077733		 SUPPL-1 TOPIRAMATE PHARMACO Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #077733		 SUPPL-4 TOPIRAMATE PHARMACO Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #077733		 SUPPL-5 TOPIRAMATE PHARMACO Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078235		 SUPPL-8 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078235		 SUPPL-10 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078235		 SUPPL-12 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078235		 SUPPL-14 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078877		 SUPPL-3 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078877		 SUPPL-5 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078877		 SUPPL-7 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 TOPIRAMATE
ANDA #078877		 SUPPL-8 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
11/18/2014 ALFUZOSIN HYDROCHLORIDE
ANDA #079054		 SUPPL-4 ALFUZOSIN HYDROCHLORIDE TORRENT PHARMS Manufacturing (CMC) Approval
11/18/2014 BRIMONIDINE TARTRATE
ANDA #091691		 ORIG-1 BRIMONIDINE TARTRATE REGCON HOLDINGS Approval
11/18/2014 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #203330		 ORIG-1 FEXOFENADINE HYDROCHLORIDE P AND L Approval
11/18/2014 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #203330		 ORIG-1 FEXOFENADINE HYDROCHLORIDE P AND L Approval
11/18/2014 PARICALCITOL
NDA #205917		 ORIG-1 PARICALCITOL HIKMA PHARMS Type 5 - New Formulation or New Manufacturer Approval
11/19/2014 LIORESAL
NDA #020075		 SUPPL-31 BACLOFEN AMNEAL Labeling Approval
11/19/2014 CREON
BLA #020725		 SUPPL-20 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) ABBVIE Approval
11/19/2014 AVELOX
NDA #021085		 SUPPL-58 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
11/19/2014 INTUNIV
NDA #022037		 SUPPL-10 GUANFACINE HYDROCHLORIDE TAKEDA PHARMS USA Efficacy Approval
11/19/2014 ISOSORBIDE DINITRATE
ANDA #040009		 SUPPL-8 ISOSORBIDE DINITRATE SUN PHARM INDS INC Manufacturing (CMC) Approval
11/19/2014 TOPIRAMATE
ANDA #076343		 SUPPL-6 TOPIRAMATE CIPLA LTD Labeling Approval
11/19/2014 TOPIRAMATE
ANDA #078499		 SUPPL-7 TOPIRAMATE AIPING PHARM INC Labeling Approval
11/19/2014 TOPIRAMATE
ANDA #078499		 SUPPL-8 TOPIRAMATE AIPING PHARM INC Labeling Approval
11/19/2014 JEVTANA KIT
NDA #201023		 SUPPL-11 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
11/19/2014 TOBI PODHALER
NDA #201688		 SUPPL-4 TOBRAMYCIN VIATRIS Labeling Approval
11/19/2014 YAELA
ANDA #202015		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL NOVAST LABS Approval
11/19/2014 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #202039		 ORIG-1 FEXOFENADINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
11/19/2014 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #202039		 ORIG-1 FEXOFENADINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
11/19/2014 SODIUM FLUORIDE F-18
ANDA #204328		 ORIG-1 SODIUM FLUORIDE F-18 THE FEINSTEIN INST Approval
11/20/2014 ISORDIL
NDA #012093		 SUPPL-51 ISOSORBIDE DINITRATE BAUSCH Manufacturing (CMC) Approval
11/20/2014 DEPAKENE
NDA #018081		 SUPPL-58 VALPROIC ACID ABBVIE Labeling Approval
11/20/2014 DEPAKENE
NDA #018082		 SUPPL-41 VALPROIC ACID ABBVIE Labeling Approval
11/20/2014 BILTRICIDE
NDA #018714		 SUPPL-15 PRAZIQUANTEL BAYER HLTHCARE Manufacturing (CMC) Approval
11/20/2014 DEPAKOTE
NDA #018723		 SUPPL-50 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/20/2014 DEPAKOTE
NDA #019680		 SUPPL-37 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/20/2014 DEPACON
NDA #020593		 SUPPL-28 VALPROATE SODIUM ABBVIE Labeling Approval
11/20/2014 GLIADEL
NDA #020637		 SUPPL-27 CARMUSTINE AZURITY Labeling Approval
11/20/2014 LOCOID LIPOCREAM
NDA #020769		 SUPPL-14 HYDROCORTISONE BUTYRATE PRECISION DERMAT Labeling Approval
11/20/2014 CARAC
NDA #020985		 SUPPL-16 FLUOROURACIL EXTROVIS Manufacturing (CMC) Approval
11/20/2014 PRIFTIN
NDA #021024		 SUPPL-10 RIFAPENTINE SANOFI AVENTIS US Labeling Approval
11/20/2014 AVELOX
NDA #021085		 SUPPL-59 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
11/20/2014 DEPAKOTE ER
NDA #021168		 SUPPL-26 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/20/2014 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
NDA #021277		 SUPPL-55 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
11/20/2014 DALVANCE
NDA #021883		 SUPPL-1 DALBAVANCIN HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
11/20/2014 JENLOGA
NDA #022331		 SUPPL-14 CLONIDINE HYDROCHLORIDE CONCORDIA PHARMS INC Efficacy Approval
11/20/2014 KAPVAY
NDA #022331		 SUPPL-14 CLONIDINE HYDROCHLORIDE CONCORDIA PHARMS INC Efficacy Approval
11/20/2014 NORCO
ANDA #040099		 SUPPL-18 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #075932		 SUPPL-33 BUPROPION HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #075932		 SUPPL-34 BUPROPION HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #076143		 SUPPL-11 BUPROPION HYDROCHLORIDE APOTEX Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #076143		 SUPPL-12 BUPROPION HYDROCHLORIDE APOTEX Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #076143		 SUPPL-16 BUPROPION HYDROCHLORIDE APOTEX Labeling Approval
11/20/2014 IBUPROFEN
ANDA #076460		 SUPPL-7 IBUPROFEN AVEMA PHARMA Manufacturing (CMC) Approval
11/20/2014 TUSSICAPS
ANDA #077273		 SUPPL-8 CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX ECR PHARMA Labeling Approval
11/20/2014 FINASTERIDE
ANDA #077335		 ORIG-1 FINASTERIDE CIPLA Approval
11/20/2014 TOPIRAMATE
ANDA #078462		 SUPPL-7 TOPIRAMATE AUROBINDO PHARMA Labeling Approval
11/20/2014 TOPIRAMATE
ANDA #078462		 SUPPL-8 TOPIRAMATE AUROBINDO PHARMA Labeling Approval
11/20/2014 TOPIRAMATE
ANDA #078462		 SUPPL-9 TOPIRAMATE AUROBINDO PHARMA Labeling Approval
11/20/2014 TOPIRAMATE
ANDA #078462		 SUPPL-13 TOPIRAMATE AUROBINDO PHARMA Labeling Approval
11/20/2014 TOPIRAMATE
ANDA #078462		 SUPPL-14 TOPIRAMATE AUROBINDO PHARMA Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #078866		 SUPPL-6 BUPROPION HYDROCHLORIDE SUN PHARM Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #078866		 SUPPL-10 BUPROPION HYDROCHLORIDE SUN PHARM Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #079095		 SUPPL-13 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #079095		 SUPPL-16 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
11/20/2014 DIVALPROEX SODIUM
ANDA #090070		 SUPPL-1 DIVALPROEX SODIUM REDDYS Labeling Approval
11/20/2014 DIVALPROEX SODIUM
ANDA #090070		 SUPPL-4 DIVALPROEX SODIUM REDDYS Labeling Approval
11/20/2014 DIVALPROEX SODIUM
ANDA #090070		 SUPPL-5 DIVALPROEX SODIUM REDDYS Labeling Approval
11/20/2014 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-8 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/20/2014 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-9 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #090941		 SUPPL-6 BUPROPION HYDROCHLORIDE RISING Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #090941		 SUPPL-7 BUPROPION HYDROCHLORIDE RISING Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #091459		 SUPPL-8 BUPROPION HYDROCHLORIDE PH HEALTH Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #201567		 SUPPL-4 BUPROPION HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
11/20/2014 STENDRA
NDA #202276		 SUPPL-7 AVANAFIL VIVUS LLC Manufacturing (CMC) Approval
11/20/2014 ZOLMITRIPTAN
ANDA #202279		 ORIG-1 ZOLMITRIPTAN JUBILANT GENERICS Approval
11/20/2014 DIVALPROEX SODIUM
ANDA #202419		 SUPPL-2 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/20/2014 DIVALPROEX SODIUM
ANDA #202419		 SUPPL-3 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #202774		 SUPPL-1 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Labeling Approval
11/20/2014 BUPROPION HYDROCHLORIDE
ANDA #202774		 SUPPL-3 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Labeling Approval
11/20/2014 ZOLEDRONIC ACID
ANDA #202837		 SUPPL-2 ZOLEDRONIC ACID HOSPIRA INC Labeling Approval
11/20/2014 AMMONIA N 13
ANDA #204535		 ORIG-1 AMMONIA N-13 MIPS CRF Approval
11/20/2014 ALEVE PM
NDA #205352		 SUPPL-2 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
11/20/2014 HYSINGLA ER
NDA #206627		 ORIG-1 HYDROCODONE BITARTRATE KNOA PHARMA Type 3 - New Dosage Form Approval
11/21/2014 CARDIZEM
NDA #018602		 SUPPL-65 DILTIAZEM HYDROCHLORIDE BAUSCH Labeling Approval
11/21/2014 CREON
BLA #020725		 SUPPL-18 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) ABBVIE Approval
11/21/2014 WELLBUTRIN XL
NDA #021515		 SUPPL-31 BUPROPION HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
11/21/2014 SENSIPAR
NDA #021688		 SUPPL-20 CINACALCET HYDROCHLORIDE AMGEN Labeling Approval
11/21/2014 SENSIPAR
NDA #021688		 SUPPL-21 CINACALCET HYDROCHLORIDE AMGEN Efficacy Approval
11/21/2014 SENSIPAR
NDA #021688		 SUPPL-22 CINACALCET HYDROCHLORIDE AMGEN Labeling Approval
11/21/2014 AMLODIPINE BESYLATE
ANDA #078226		 SUPPL-11 AMLODIPINE BESYLATE ZYDUS PHARMS USA Labeling Approval
11/21/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-11 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
11/21/2014 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ANDA #088017		 SUPPL-45 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE ACTAVIS MID ATLANTIC Labeling Approval
11/21/2014 TESTOSTERONE ENANTHATE
ANDA #091120		 SUPPL-2 TESTOSTERONE ENANTHATE HIKMA FARMACEUTICA Labeling Approval
11/22/2014 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-1 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
11/22/2014 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-3 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
11/22/2014 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-4 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
11/23/2014 ADCETRIS
BLA #125388		 SUPPL-56 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
11/23/2014 ADCETRIS
BLA #125388		 SUPPL-78 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
11/24/2014 CIS-PYRO
NDA #019039		 SUPPL-9 TECHNETIUM TC-99M PYROPHOSPHATE KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
11/24/2014 CATAFLAM
NDA #020142		 SUPPL-26 DICLOFENAC POTASSIUM NOVARTIS Manufacturing (CMC) Approval
11/24/2014 OPTIMARK
NDA #020937		 SUPPL-24 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
11/24/2014 OPTIMARK
NDA #020975		 SUPPL-25 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
11/24/2014 OPTIMARK IN PLASTIC CONTAINER
NDA #020976		 SUPPL-26 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
11/24/2014 LAMISIL
NDA #020980		 SUPPL-11 TERBINAFINE HYDROCHLORIDE KARO HLTHCARE Manufacturing (CMC) Approval
11/24/2014 BYETTA
NDA #021773		 SUPPL-36 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
11/24/2014 DICLEGIS
NDA #021876		 SUPPL-5 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Manufacturing (CMC) Approval
11/24/2014 ZYCLARA
NDA #022483		 SUPPL-7 IMIQUIMOD BAUSCH Manufacturing (CMC) Approval
11/24/2014 ACANYA
NDA #050819		 SUPPL-12 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Efficacy Approval
11/24/2014 ONEXTON
NDA #050819		 SUPPL-12 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Efficacy Approval
11/24/2014 CITALOPRAM HYDROBROMIDE
ANDA #077045		 SUPPL-3 CITALOPRAM HYDROBROMIDE EPIC PHARMA Labeling Approval
11/24/2014 CITALOPRAM HYDROBROMIDE
ANDA #077045		 SUPPL-4 CITALOPRAM HYDROBROMIDE EPIC PHARMA Labeling Approval
11/24/2014 CITALOPRAM HYDROBROMIDE
ANDA #077045		 SUPPL-6 CITALOPRAM HYDROBROMIDE EPIC PHARMA Labeling Approval
11/24/2014 ZOLEDRONIC ACID
ANDA #091493		 ORIG-1 ZOLEDRONIC ACID SAGENT PHARMS INC Approval
11/24/2014 NITHIODOTE
NDA #201444		 SUPPL-13 SODIUM NITRITE; SODIUM THIOSULFATE HOPE PHARMS Manufacturing (CMC) Approval
11/24/2014 DICLOFENAC SODIUM
ANDA #202393		 ORIG-1 DICLOFENAC SODIUM TWI PHARMS Approval
11/24/2014 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202585		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE RISING Approval
11/24/2014 DICLOFENAC SODIUM
ANDA #202852		 ORIG-1 DICLOFENAC SODIUM WATSON LABS INC Approval
11/25/2014 XALATAN
NDA #020597		 SUPPL-45 LATANOPROST UPJOHN Labeling Approval
11/25/2014 XALATAN
NDA #020597		 SUPPL-48 LATANOPROST UPJOHN Labeling Approval
11/25/2014 PRIFTIN
NDA #021024		 SUPPL-11 RIFAPENTINE SANOFI AVENTIS US Efficacy Approval
11/25/2014 CYMBALTA
NDA #021427		 SUPPL-37 DULOXETINE HYDROCHLORIDE LILLY Labeling Approval
11/25/2014 CYMBALTA
NDA #021427		 SUPPL-42 DULOXETINE HYDROCHLORIDE LILLY Labeling Approval
11/25/2014 VOLTAREN ARTHRITIS PAIN
NDA #022122		 SUPPL-7 DICLOFENAC SODIUM HALEON US HOLDINGS Labeling Approval
11/25/2014 AMOXICILLIN
ANDA #064076		 SUPPL-27 AMOXICILLIN SANDOZ Labeling Approval
11/25/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065066		 SUPPL-19 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
11/25/2014 AMOXICILLIN
ANDA #065228		 SUPPL-7 AMOXICILLIN SANDOZ Labeling Approval
11/25/2014 AMOXICILLIN
ANDA #065291		 SUPPL-9 AMOXICILLIN HIKMA PHARMS Labeling Approval
11/25/2014 AMOXICILLIN
ANDA #065378		 SUPPL-9 AMOXICILLIN SANDOZ Labeling Approval
11/25/2014 AMOXICILLIN
ANDA #065387		 SUPPL-9 AMOXICILLIN SANDOZ Labeling Approval
11/25/2014 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077157		 SUPPL-4 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TEVA PHARMS Labeling Approval
11/25/2014 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077157		 SUPPL-8 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TEVA PHARMS Labeling Approval
11/25/2014 LUCENTIS
BLA #125156		 SUPPL-105 RANIBIZUMAB GENENTECH Approval
11/25/2014 SIMVASTATIN
ANDA #200895		 ORIG-1 SIMVASTATIN HETERO LABS LTD III Approval
11/25/2014 ZELBORAF
NDA #202429		 SUPPL-6 VEMURAFENIB HOFFMANN LA ROCHE Labeling Approval
11/25/2014 BOSULIF
NDA #203341		 SUPPL-2 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
11/25/2014 NITROUS OXIDE, USP
NDA #208069		 ORIG-1 NITROUS OXIDE STRATA MEDICAL INNOVATIONS Medical Gas Approval
11/26/2014 MYTELASE
NDA #010155		 SUPPL-24 AMBENONIUM CHLORIDE SANOFI AVENTIS US Labeling Approval
11/26/2014 PARLODEL
NDA #017962		 SUPPL-75 BROMOCRIPTINE MESYLATE ESJAY PHARMA Manufacturing (CMC) Approval
11/26/2014 MICRO-K
NDA #018238		 SUPPL-43 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
11/26/2014 MICRO-K 10
NDA #018238		 SUPPL-43 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
11/26/2014 TOPICORT
NDA #018594		 SUPPL-10 DESOXIMETASONE TARO Manufacturing (CMC) Approval
11/26/2014 TOPICORT
NDA #018594		 SUPPL-11 DESOXIMETASONE TARO Manufacturing (CMC) Approval
11/26/2014 MAGNESIUM SULFATE IN PLASTIC CONTAINER
NDA #020309		 SUPPL-30 MAGNESIUM SULFATE HOSPIRA Manufacturing (CMC) Approval
11/26/2014 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020488		 SUPPL-21 MAGNESIUM SULFATE HOSPIRA Manufacturing (CMC) Approval
11/26/2014 ALDARA
NDA #020723		 SUPPL-25 IMIQUIMOD BAUSCH Manufacturing (CMC) Approval
11/26/2014 SINGULAIR
NDA #020829		 SUPPL-68 MONTELUKAST SODIUM ORGANON Labeling Approval
11/26/2014 SINGULAIR
NDA #020830		 SUPPL-70 MONTELUKAST SODIUM ORGANON Labeling Approval
11/26/2014 TAMIFLU
NDA #021087		 SUPPL-60 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
11/26/2014 YASMIN
NDA #021098		 SUPPL-24 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
11/26/2014 RENAGEL
NDA #021179		 SUPPL-30 SEVELAMER HYDROCHLORIDE GENZYME Labeling Approval
11/26/2014 TAMIFLU
NDA #021246		 SUPPL-43 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
11/26/2014 SINGULAIR
NDA #021409		 SUPPL-45 MONTELUKAST SODIUM ORGANON Labeling Approval
11/26/2014 CUBICIN
NDA #021572		 SUPPL-46 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
11/26/2014 CUBICIN RF
NDA #021572		 SUPPL-46 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
11/26/2014 ATRIPLA
NDA #021937		 SUPPL-33 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Manufacturing (CMC) Approval
11/26/2014 RENVELA
NDA #022127		 SUPPL-11 SEVELAMER CARBONATE SANOFI Labeling Approval
11/26/2014 RENVELA
NDA #022318		 SUPPL-5 SEVELAMER CARBONATE GENZYME Labeling Approval
11/26/2014 CEFTRIAXONE
ANDA #065328		 SUPPL-10 CEFTRIAXONE SODIUM ACS DOBFAR Labeling Approval
11/26/2014 DOXYCYCLINE
ANDA #065353		 SUPPL-3 DOXYCYCLINE SANDOZ INC Labeling Approval
11/26/2014 NEOMYCIN SULFATE
ANDA #065468		 SUPPL-2 NEOMYCIN SULFATE PHARMOBEDIENT Labeling Approval
11/26/2014 MINOCYCLINE HYDROCHLORIDE
ANDA #065485		 SUPPL-7 MINOCYCLINE HYDROCHLORIDE BARR LABS INC Labeling Approval
11/26/2014 DICLOFENAC SODIUM
ANDA #074376		 SUPPL-35 DICLOFENAC SODIUM CHARTWELL RX Labeling Approval
11/26/2014 DICLOFENAC SODIUM
ANDA #074394		 SUPPL-43 DICLOFENAC SODIUM CHARTWELL RX Labeling Approval
11/26/2014 PAROXETINE HYDROCHLORIDE
ANDA #077584		 SUPPL-23 PAROXETINE HYDROCHLORIDE ZYDUS PHARMS USA Manufacturing (CMC) Approval
11/26/2014 CARVEDILOL
ANDA #078251		 SUPPL-9 CARVEDILOL GLENMARK PHARMS LTD Manufacturing (CMC) Approval
11/26/2014 ZOLPIDEM TARTRATE
ANDA #078426		 SUPPL-6 ZOLPIDEM TARTRATE WOCKHARDT Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450		 SUPPL-6 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450		 SUPPL-7 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450		 SUPPL-10 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450		 SUPPL-11 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450		 SUPPL-12 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/26/2014 DIVALPROEX SODIUM
ANDA #090210		 SUPPL-2 DIVALPROEX SODIUM PRINSTON INC Labeling Approval
11/26/2014 DIVALPROEX SODIUM
ANDA #090210		 SUPPL-6 DIVALPROEX SODIUM PRINSTON INC Labeling Approval
11/26/2014 DIVALPROEX SODIUM
ANDA #090210		 SUPPL-7 DIVALPROEX SODIUM PRINSTON INC Labeling Approval
11/26/2014 DIVALPROEX SODIUM
ANDA #090210		 SUPPL-8 DIVALPROEX SODIUM PRINSTON INC Labeling Approval
11/26/2014 DIVALPROEX SODIUM
ANDA #090210		 SUPPL-9 DIVALPROEX SODIUM PRINSTON INC Labeling Approval
11/26/2014 DIVALPROEX SODIUM
ANDA #090210		 SUPPL-10 DIVALPROEX SODIUM PRINSTON INC Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524		 SUPPL-2 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE APOTEX Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524		 SUPPL-3 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE APOTEX Labeling Approval
11/26/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524		 SUPPL-4 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE APOTEX Labeling Approval
11/26/2014 DOXYCYCLINE
ANDA #202778		 SUPPL-4 DOXYCYCLINE STRIDES PHARMA Labeling Approval
11/26/2014 SILDENAFIL CITRATE
ANDA #203623		 ORIG-1 SILDENAFIL CITRATE HETERO LABS LTD V Approval
11/26/2014 DICLOFENAC SODIUM
ANDA #203818		 ORIG-1 DICLOFENAC SODIUM SUN PHARMA CANADA Approval
11/26/2014 HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #203838		 ORIG-1 CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE TRIS PHARMA INC Approval
11/26/2014 CLINOLIPID 20%
NDA #204508		 SUPPL-3 OLIVE OIL; SOYBEAN OIL BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
11/26/2014 TREZIX
ANDA #204785		 ORIG-1 ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE KEY THERAP Approval
11/28/2014 PHENYTOIN
ANDA #040884		 ORIG-1 PHENYTOIN EPIC PHARMA LLC Approval
11/28/2014 MINOXIDIL
ANDA #071839		 SUPPL-9 MINOXIDIL PH HEALTH Manufacturing (CMC) Approval
11/28/2014 DICLOFENAC SODIUM
ANDA #075281		 SUPPL-7 DICLOFENAC SODIUM AUROBINDO PHARMA USA Labeling Approval
11/28/2014 GILDESS 1.5/30
ANDA #077075		 SUPPL-7 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE PH HEALTH Labeling Approval
11/28/2014 GILDESS FE 1.5/30
ANDA #077075		 SUPPL-7 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE PH HEALTH Labeling Approval
11/28/2014 GILDESS 1/20
ANDA #077077		 SUPPL-7 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE PH HEALTH Labeling Approval
11/28/2014 GILDESS FE 1/20
ANDA #077077		 SUPPL-7 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE PH HEALTH Labeling Approval
11/28/2014 RISPERIDONE
ANDA #077542		 SUPPL-4 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
11/28/2014 MELOXICAM
ANDA #078039		 SUPPL-2 MELOXICAM CR DOUBLE CRANE Manufacturing (CMC) Approval
11/28/2014 RISPERIDONE
ANDA #078116		 SUPPL-11 RISPERIDONE SANDOZ Labeling Approval
11/28/2014 RISPERIDONE
ANDA #078474		 SUPPL-4 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
11/28/2014 ORGATRAX
ANDA #087014		 SUPPL-6 HYDROXYZINE HYDROCHLORIDE ORGANON USA INC Labeling Approval
11/28/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #091176		 SUPPL-3 HYDROXYZINE HYDROCHLORIDE RISING Labeling Approval
11/28/2014 RISPERIDONE
ANDA #091384		 SUPPL-4 RISPERIDONE AMNEAL PHARMS Labeling Approval
11/28/2014 RISPERIDONE
ANDA #091537		 SUPPL-6 RISPERIDONE NATCO PHARMA USA Labeling Approval
11/28/2014 SODIUM POLYSTYRENE SULFONATE
ANDA #204071		 ORIG-1 SODIUM POLYSTYRENE SULFONATE NUVO PHARMS INC Approval
11/28/2014 SODIUM FLUORIDE F-18
ANDA #204513		 ORIG-1 SODIUM FLUORIDE F-18 NCM USA BRONX LLC Approval
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