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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 2016

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 May 21, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/01/2016 FLUOROPLEX
NDA #016988		 SUPPL-28 FLUOROURACIL CHARTWELL RX Manufacturing (CMC) Approval
03/01/2016 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BLA #017881		 SUPPL-24 TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT DRAXIMAGE Approval
03/01/2016 ZOCOR
NDA #019766		 SUPPL-95 SIMVASTATIN ORGANON Manufacturing (CMC) Approval
03/01/2016 RISPERDAL
NDA #020272		 SUPPL-77 RISPERIDONE JANSSEN PHARMS Labeling Approval
03/01/2016 RISPERDAL
NDA #020588		 SUPPL-65 RISPERIDONE JANSSEN PHARMS Labeling Approval
03/01/2016 FASLODEX
NDA #021344		 SUPPL-25 FULVESTRANT ASTRAZENECA Labeling Approval
03/01/2016 RISPERDAL CONSTA
NDA #021346		 SUPPL-55 RISPERIDONE JANSSEN PHARMS Labeling Approval
03/01/2016 RISPERDAL
NDA #021444		 SUPPL-51 RISPERIDONE JANSSEN PHARMS Labeling Approval
03/01/2016 ZORTRESS
NDA #021560		 SUPPL-17 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
03/01/2016 INVEGA
NDA #021999		 SUPPL-30 PALIPERIDONE JANSSEN PHARMS Labeling Approval
03/01/2016 INVEGA SUSTENNA
NDA #022264		 SUPPL-19 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
03/01/2016 MAXIPIME
NDA #050679		 SUPPL-40 CEFEPIME HYDROCHLORIDE HOSPIRA INC Labeling Approval
03/01/2016 CLINDESSE
NDA #050793		 SUPPL-21 CLINDAMYCIN PHOSPHATE PADAGIS US Manufacturing (CMC) Approval
03/01/2016 MONTELUKAST SODIUM
ANDA #201515		 SUPPL-3 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
03/01/2016 PALONOSETRON HYDROCHLORIDE
NDA #203050		 ORIG-1 PALONOSETRON HYDROCHLORIDE AVYXA HOLDINGS Type 5 - New Formulation or New Manufacturer Approval
03/01/2016 BUPROPION HYDROCHLORIDE
ANDA #205794		 ORIG-1 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Approval
03/01/2016 INVEGA HAFYERA
NDA #207946		 SUPPL-1 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
03/01/2016 INVEGA TRINZA
NDA #207946		 SUPPL-1 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
03/01/2016 ODEFSEY
NDA #208351		 ORIG-1 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Type 4 - New Combination Approval
03/02/2016 RHINOCORT
NDA #020746		 SUPPL-35 BUDESONIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
03/02/2016 RHINOCORT ALLERGY
NDA #020746		 SUPPL-35 BUDESONIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
03/02/2016 FORADIL
NDA #020831		 SUPPL-34 FORMOTEROL FUMARATE NOVARTIS Manufacturing (CMC) Approval
03/02/2016 VENOFER
NDA #021135		 SUPPL-26 FERRIC OXYHYDROXIDE AM REGENT Manufacturing (CMC) Approval
03/02/2016 ATNAA
NDA #021175		 SUPPL-27 ATROPINE; PRALIDOXIME CHLORIDE US ARMY Manufacturing (CMC) Approval
03/02/2016 FASLODEX
NDA #021344		 SUPPL-26 FULVESTRANT ASTRAZENECA Efficacy Approval
03/02/2016 DUODOTE
NDA #021983		 SUPPL-18 ATROPINE; PRALIDOXIME CHLORIDE MMT Manufacturing (CMC) Approval
03/02/2016 CEFTRIAXONE
ANDA #065180		 SUPPL-5 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
03/02/2016 CEFTRIAXONE
ANDA #065180		 SUPPL-7 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
03/02/2016 CEFTRIAXONE
ANDA #065328		 SUPPL-12 CEFTRIAXONE SODIUM ACS DOBFAR Labeling Approval
03/02/2016 CEFTRIAXONE
ANDA #065329		 SUPPL-10 CEFTRIAXONE SODIUM ACS DOBFAR Labeling Approval
03/02/2016 CEFTRIAXONE
ANDA #065391		 SUPPL-5 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
03/02/2016 CEFTRIAXONE
ANDA #065391		 SUPPL-7 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
03/02/2016 BETAMETHASONE DIPROPIONATE
ANDA #076543		 SUPPL-10 BETAMETHASONE DIPROPIONATE TARO Labeling Approval
03/02/2016 PROLIA
BLA #125320		 SUPPL-177 DENOSUMAB AMGEN Approval
03/02/2016 XGEVA
BLA #125320		 SUPPL-177 DENOSUMAB AMGEN Approval
03/02/2016 ELIQUIS
NDA #202155		 SUPPL-14 APIXABAN BRISTOL MYERS SQUIBB REMS Approval
03/02/2016 RITONAVIR
ANDA #202738		 ORIG-1 RITONAVIR MYLAN PHARMS INC Tentative Approval
03/02/2016 NYMALIZE
NDA #203340		 SUPPL-1 NIMODIPINE AZURITY Manufacturing (CMC) Approval
03/02/2016 KENGREAL
NDA #204958		 SUPPL-1 CANGRELOR CHIESI Manufacturing (CMC) Approval
03/02/2016 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #207349		 ORIG-1 MAGNESIUM SULFATE HQ SPCLT PHARMA Approval
03/03/2016 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016677		 SUPPL-151 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/03/2016 EPI E Z PEN JR
NDA #019430		 SUPPL-60 EPINEPHRINE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/03/2016 EPIPEN
NDA #019430		 SUPPL-60 EPINEPHRINE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/03/2016 EPIPEN E Z PEN
NDA #019430		 SUPPL-60 EPINEPHRINE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/03/2016 EPIPEN JR.
NDA #019430		 SUPPL-60 EPINEPHRINE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/03/2016 CEREZYME
BLA #020367		 SUPPL-96 IMIGLUCERASE GENZYME Approval
03/03/2016 CEREBYX
NDA #020450		 SUPPL-29 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
03/03/2016 PROVENTIL-HFA
NDA #020503		 SUPPL-51 ALBUTEROL SULFATE KINDEVA Manufacturing (CMC) Approval
03/03/2016 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-31 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
03/03/2016 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-33 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
03/03/2016 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-34 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
03/03/2016 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-36 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
03/03/2016 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-37 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
03/03/2016 ONDANSETRON HYDROCHLORIDE
ANDA #091342		 SUPPL-4 ONDANSETRON HYDROCHLORIDE CHARTWELL MOLECULAR Manufacturing (CMC) Approval
03/03/2016 ZARXIO
BLA #125553		 SUPPL-1 FILGRASTIM-SNDZ SANDOZ INC Approval
03/03/2016 OXYTROL FOR WOMEN
NDA #202211		 SUPPL-4 OXYBUTYNIN ABBVIE Labeling Approval
03/03/2016 RIFAMPIN
ANDA #205039		 ORIG-1 RIFAMPIN HIKMA PHARMS Approval
03/03/2016 ALMOTRIPTAN MALATE
ANDA #205523		 ORIG-1 ALMOTRIPTAN MALATE AJANTA PHARMA LTD Approval
03/04/2016 ACTHAR GEL
NDA #008372		 SUPPL-48 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/04/2016 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-48 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/04/2016 LASIX
NDA #016273		 SUPPL-68 FUROSEMIDE VALIDUS PHARMS Labeling Approval
03/04/2016 YAZ
NDA #021676		 SUPPL-15 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
03/04/2016 MAXIPIME
NDA #050679		 SUPPL-39 CEFEPIME HYDROCHLORIDE HOSPIRA INC Manufacturing (CMC) Approval
03/04/2016 ALENDRONATE SODIUM
ANDA #076984		 SUPPL-10 ALENDRONATE SODIUM WATSON LABS Labeling Approval
03/04/2016 ALENDRONATE SODIUM
ANDA #076984		 SUPPL-14 ALENDRONATE SODIUM WATSON LABS Labeling Approval
03/04/2016 DONEPEZIL HYDROCHLORIDE
ANDA #090551		 SUPPL-4 DONEPEZIL HYDROCHLORIDE STRIDES PHARMA Labeling Approval
03/04/2016 FAMCICLOVIR
ANDA #091480		 SUPPL-2 FAMCICLOVIR APOTEX Labeling Approval
03/04/2016 ADCETRIS
BLA #125388		 SUPPL-84 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
03/04/2016 POTASSIUM CHLORIDE
ANDA #201944		 ORIG-1 POTASSIUM CHLORIDE TRIS PHARMA INC Approval
03/04/2016 SODIUM BICARBONATE
ANDA #202981		 ORIG-1 SODIUM BICARBONATE HOSPIRA Approval
03/04/2016 LAMIVUDINE
ANDA #204528		 ORIG-1 LAMIVUDINE MYLAN Approval
03/04/2016 VARITHENA
NDA #205098		 SUPPL-13 POLIDOCANOL PROVENSIS Manufacturing (CMC) Approval
03/04/2016 IMBRUVICA
NDA #205552		 SUPPL-7 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
03/04/2016 CLOFARABINE
ANDA #208167		 ORIG-1 CLOFARABINE ZYDUS PHARMS USA INC Tentative Approval
03/05/2016 PIPERACILLIN
ANDA #065114		 SUPPL-13 PIPERACILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
03/05/2016 PIPERACILLIN
ANDA #065157		 SUPPL-9 PIPERACILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
03/05/2016 CEFTRIAXONE
ANDA #065168		 SUPPL-22 CEFTRIAXONE SODIUM SANDOZ Labeling Approval
03/05/2016 CEFTRIAXONE
ANDA #065168		 SUPPL-23 CEFTRIAXONE SODIUM SANDOZ Labeling Approval
03/05/2016 CEFTRIAXONE
ANDA #065169		 SUPPL-25 CEFTRIAXONE SODIUM SANDOZ Labeling Approval
03/05/2016 CEFTRIAXONE
ANDA #065169		 SUPPL-26 CEFTRIAXONE SODIUM SANDOZ Labeling Approval
03/05/2016 CEFTRIAXONE
ANDA #065204		 SUPPL-15 CEFTRIAXONE SODIUM SANDOZ INC Labeling Approval
03/05/2016 CEFTRIAXONE
ANDA #065204		 SUPPL-16 CEFTRIAXONE SODIUM SANDOZ INC Labeling Approval
03/05/2016 CEFTRIAXONE
ANDA #065204		 SUPPL-17 CEFTRIAXONE SODIUM SANDOZ INC Labeling Approval
03/05/2016 METHYLPHENIDATE HYDROCHLORIDE
ANDA #078458		 SUPPL-9 METHYLPHENIDATE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
03/07/2016 CHORIONIC GONADOTROPIN
BLA #017016		 SUPPL-160 GONADOTROPIN, CHORIONIC FERRING Approval
03/07/2016 NAMENDA
NDA #021487		 SUPPL-21 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
03/07/2016 HYDROCHLOROTHIAZIDE
ANDA #040907		 SUPPL-9 HYDROCHLOROTHIAZIDE UNICHEM Manufacturing (CMC) Approval
03/07/2016 METFORMIN HYDROCHLORIDE
ANDA #200690		 SUPPL-2 METFORMIN HYDROCHLORIDE MYLAN PHARMS INC Manufacturing (CMC) Approval
03/07/2016 OXAYDO
NDA #202080		 SUPPL-4 OXYCODONE HYDROCHLORIDE ZYLA Manufacturing (CMC) Approval
03/07/2016 RYZODEG 70/30
BLA #203313		 SUPPL-1 INSULIN ASPART; INSULIN DEGLUDEC NOVO Approval
03/07/2016 LOPINAVIR; RITONAVIR
ANDA #204739		 ORIG-1 LOPINAVIR;RITONAVIR MACLEODS PHARMS LTD Tentative Approval
03/07/2016 OXICONAZOLE NITRATE
ANDA #205076		 ORIG-1 OXICONAZOLE NITRATE TARO Approval
03/07/2016 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #206486		 ORIG-1 MAGNESIUM SULFATE FRESENIUS KABI USA Approval
03/08/2016 FUROSEMIDE
NDA #018487		 SUPPL-43 FUROSEMIDE MYLAN Labeling Approval
03/08/2016 FUROSEMIDE
NDA #018902		 SUPPL-27 FUROSEMIDE FRESENIUS KABI USA Labeling Approval
03/08/2016 ANGIOMAX
NDA #020873		 SUPPL-34 BIVALIRUDIN SANDOZ Manufacturing (CMC) Approval
03/08/2016 TIKOSYN
NDA #020931		 SUPPL-12 DOFETILIDE PFIZER Labeling Approval
03/08/2016 TIKOSYN
NDA #020931		 SUPPL-13 DOFETILIDE PFIZER REMS Approval
03/08/2016 YASMIN
NDA #021098		 SUPPL-26 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
03/08/2016 CLIMARA PRO
NDA #021258		 SUPPL-10 ESTRADIOL; LEVONORGESTREL BAYER HLTHCARE Manufacturing (CMC) Approval
03/08/2016 DACOGEN
NDA #021790		 SUPPL-19 DECITABINE OTSUKA Manufacturing (CMC) Approval
03/08/2016 QUETIAPINE FUMARATE
ANDA #202674		 ORIG-1 QUETIAPINE FUMARATE UNICHEM Approval
03/08/2016 OXYCODONE AND ACETAMINOPHEN
ANDA #202677		 SUPPL-5 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ALVOGEN Manufacturing (CMC) Approval
03/08/2016 JUXTAPID
NDA #203858		 SUPPL-12 LOMITAPIDE MESYLATE CHIESI Labeling Approval
03/08/2016 INVOKANA
NDA #204042		 SUPPL-12 CANAGLIFLOZIN JANSSEN PHARMS Manufacturing (CMC) Approval
03/08/2016 BUDESONIDE
ANDA #204548		 ORIG-1 BUDESONIDE TEVA PHARMS USA Approval
03/08/2016 NEURACEQ
NDA #204677		 SUPPL-13 FLORBETABEN F-18 LIFE MOLECULAR Manufacturing (CMC) Approval
03/08/2016 ASPIRIN AND DIPYRIDAMOLE
ANDA #206392		 ORIG-1 ASPIRIN; DIPYRIDAMOLE AMNEAL PHARMS Approval
03/08/2016 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #206793		 ORIG-1 CETIRIZINE HYDROCHLORIDE NOVEL LABS INC Approval
03/08/2016 GENVOYA
NDA #207561		 SUPPL-3 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
03/08/2016 ENSTILAR
NDA #207589		 SUPPL-1 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
03/09/2016 QUINIDINE GLUCONATE
NDA #007529		 SUPPL-45 QUINIDINE GLUCONATE LILLY Manufacturing (CMC) Approval
03/09/2016 MICRO-K
NDA #018238		 SUPPL-45 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
03/09/2016 MICRO-K 10
NDA #018238		 SUPPL-45 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
03/09/2016 XENON XE 133
NDA #018327		 SUPPL-5 XENON XE-133 CURIUM Manufacturing (CMC) Approval
03/09/2016 MORPHINE SULFATE
NDA #019916		 SUPPL-15 MORPHINE SULFATE ICU MEDICAL INC Manufacturing (CMC) Approval
03/09/2016 PHOSLO
NDA #019976		 SUPPL-16 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
03/09/2016 ETHYOL
NDA #020221		 SUPPL-30 AMIFOSTINE CLINIGEN Manufacturing (CMC) Approval
03/09/2016 ZYRTEC-D 12 HOUR
NDA #021150		 SUPPL-13 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
03/09/2016 RENAGEL
NDA #021179		 SUPPL-32 SEVELAMER HYDROCHLORIDE GENZYME Labeling Approval
03/09/2016 AEROSPAN HFA
NDA #021247		 SUPPL-13 FLUNISOLIDE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/09/2016 LYRICA
NDA #021446		 SUPPL-30 PREGABALIN UPJOHN Labeling Approval
03/09/2016 RENVELA
NDA #022127		 SUPPL-13 SEVELAMER CARBONATE SANOFI Labeling Approval
03/09/2016 RENVELA
NDA #022318		 SUPPL-6 SEVELAMER CARBONATE GENZYME Labeling Approval
03/09/2016 LYRICA
NDA #022488		 SUPPL-10 PREGABALIN UPJOHN Labeling Approval
03/09/2016 SILDENAFIL CITRATE
ANDA #077342		 ORIG-1 SILDENAFIL CITRATE TEVA Approval
03/09/2016 ZALTRAP
BLA #125418		 SUPPL-37 ZIV-AFLIBERCEPT SANOFI AVENTIS US Approval
03/09/2016 AMYVID
NDA #202008		 SUPPL-25 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/09/2016 COMPLERA
NDA #202123		 SUPPL-26 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
03/10/2016 DELESTROGEN
NDA #009402		 SUPPL-49 ESTRADIOL VALERATE ENDO OPERATIONS Manufacturing (CMC) Approval
03/10/2016 MAXIDEX
NDA #013422		 SUPPL-42 DEXAMETHASONE HARROW EYE Manufacturing (CMC) Approval
03/10/2016 VISINE
NDA #020485		 SUPPL-10 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE JOHNSON AND JOHNSON Manufacturing (CMC) Approval
03/10/2016 MIFEPREX
NDA #020687		 SUPPL-21 MIFEPRISTONE DANCO LABS LLC Manufacturing (CMC) Approval
03/10/2016 RHINOCORT
NDA #020746		 SUPPL-33 BUDESONIDE J AND J CONSUMER INC Labeling Approval
03/10/2016 RHINOCORT ALLERGY
NDA #020746		 SUPPL-33 BUDESONIDE J AND J CONSUMER INC Labeling Approval
03/10/2016 GANIRELIX ACETATE
NDA #021057		 SUPPL-9 GANIRELIX ACETATE ORGANON USA ORGANON Manufacturing (CMC) Approval
03/10/2016 VIREAD
NDA #021356		 SUPPL-53 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
03/10/2016 FORTESTA
NDA #021463		 SUPPL-18 TESTOSTERONE ENDO OPERATIONS Manufacturing (CMC) Approval
03/10/2016 LEXIVA
NDA #021548		 SUPPL-38 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Manufacturing (CMC) Approval
03/10/2016 TRUVADA
NDA #021752		 SUPPL-47 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Efficacy Approval
03/10/2016 DICLEGIS
NDA #021876		 SUPPL-9 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Manufacturing (CMC) Approval
03/10/2016 INTELENCE
NDA #022187		 SUPPL-18 ETRAVIRINE JANSSEN R AND D Manufacturing (CMC) Approval
03/10/2016 JAKAFI
NDA #202192		 SUPPL-12 RUXOLITINIB PHOSPHATE INCYTE CORP Efficacy Approval
03/10/2016 PROCYSBI
NDA #203389		 SUPPL-14 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
03/10/2016 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #206845		 ORIG-1 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Approval
03/10/2016 EVOMELA
NDA #207155		 ORIG-1 MELPHALAN HYDROCHLORIDE ACROTECH BIOPHARMA Type 5 - New Formulation or New Manufacturer Approval
03/10/2016 EVOMELA
NDA #207155		 ORIG-2 MELPHALAN HYDROCHLORIDE ACROTECH BIOPHARMA Efficacy Approval
03/11/2016 ACTHAR GEL
NDA #008372		 SUPPL-49 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/11/2016 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-49 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/11/2016 LYSODREN
NDA #016885		 SUPPL-26 MITOTANE HRA PHARMA Labeling Approval
03/11/2016 TRAVATAN Z
NDA #021994		 SUPPL-9 TRAVOPROST SANDOZ Manufacturing (CMC) Approval
03/11/2016 PRIMAXIN
NDA #050587		 SUPPL-78 CILASTATIN SODIUM; IMIPENEM MERCK Manufacturing (CMC) Approval
03/11/2016 XALKORI
NDA #202570		 SUPPL-16 CRIZOTINIB PF PRISM CV Efficacy Approval
03/11/2016 IBANDRONATE SODIUM
ANDA #204502		 ORIG-1 IBANDRONATE SODIUM AUROBINDO PHARMA Approval
03/11/2016 FROVATRIPTAN SUCCINATE
ANDA #204730		 ORIG-1 FROVATRIPTAN SUCCINATE GLENMARK PHARMS LTD Approval
03/11/2016 RAPIVAB
NDA #206426		 SUPPL-1 PERAMIVIR BIOCRYST Manufacturing (CMC) Approval
03/11/2016 HER STYLE
ANDA #207976		 ORIG-1 LEVONORGESTREL NOVAST LABS Approval
03/14/2016 ACTHAR GEL
NDA #008372		 SUPPL-50 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/14/2016 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-50 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/14/2016 OPCON-A
NDA #020065		 SUPPL-22 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE BAUSCH AND LOMB Manufacturing (CMC) Approval
03/14/2016 COPAXONE
NDA #020622		 SUPPL-93 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
03/14/2016 OPTIMARK
NDA #020937		 SUPPL-25 GADOVERSETAMIDE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
03/14/2016 IMPLANON
NDA #021529		 SUPPL-13 ETONOGESTREL ORGANON Labeling Approval
03/14/2016 NEXPLANON
NDA #021529		 SUPPL-13 ETONOGESTREL ORGANON Labeling Approval
03/14/2016 DESONATE
NDA #021844		 SUPPL-10 DESONIDE LEO PHARMA AS Manufacturing (CMC) Approval
03/14/2016 TAZICEF
ANDA #062662		 SUPPL-23 CEFTAZIDIME HOSPIRA Labeling Approval
03/14/2016 TAZICEF
ANDA #062662		 SUPPL-27 CEFTAZIDIME HOSPIRA Labeling Approval
03/14/2016 SEVOFLURANE
ANDA #075895		 SUPPL-8 SEVOFLURANE BAXTER HLTHCARE Labeling Approval
03/14/2016 SERTRALINE HYDROCHLORIDE
ANDA #077206		 SUPPL-1 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/14/2016 SERTRALINE HYDROCHLORIDE
ANDA #077206		 SUPPL-16 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Manufacturing (CMC) Approval
03/14/2016 SERTRALINE HYDROCHLORIDE
ANDA #077206		 SUPPL-20 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/14/2016 SERTRALINE HYDROCHLORIDE
ANDA #077206		 SUPPL-24 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/14/2016 FLUTICASONE PROPIONATE
ANDA #078492		 SUPPL-5 FLUTICASONE PROPIONATE CHARTWELL RX Labeling Approval
03/14/2016 FLUOXETINE HYDROCHLORIDE
ANDA #078619		 SUPPL-8 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/14/2016 FLUOXETINE HYDROCHLORIDE
ANDA #078619		 SUPPL-10 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/14/2016 FLUOXETINE HYDROCHLORIDE
ANDA #078619		 SUPPL-11 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/14/2016 FLUOXETINE HYDROCHLORIDE
ANDA #078619		 SUPPL-12 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/14/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078894		 SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC Labeling Approval
03/14/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078894		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC Labeling Approval
03/14/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078894		 SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC Labeling Approval
03/14/2016 GABAPENTIN
ANDA #091286		 ORIG-1 GABAPENTIN BELCHER Approval
03/14/2016 DOXYCYCLINE
ANDA #200065		 SUPPL-7 DOXYCYCLINE IMPAX LABS INC Labeling Approval
03/14/2016 DOXYCYCLINE
ANDA #200065		 SUPPL-9 DOXYCYCLINE IMPAX LABS INC Labeling Approval
03/15/2016 ADVIL PM
NDA #021394		 SUPPL-20 DIPHENHYDRAMINE CITRATE; IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
03/15/2016 CUBICIN
NDA #021572		 SUPPL-51 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
03/15/2016 CUBICIN RF
NDA #021572		 SUPPL-51 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
03/15/2016 TARCEVA
NDA #021743		 SUPPL-24 ERLOTINIB HYDROCHLORIDE OSI PHARMS Manufacturing (CMC) Approval
03/15/2016 INCRELEX
BLA #021839		 SUPPL-17 MECASERMIN RECOMBINANT IPSEN INC Approval
03/15/2016 RASAGILINE MESYLATE
ANDA #201970		 ORIG-1 RASAGILINE MESYLATE ORBION PHARMS Approval
03/15/2016 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #202214		 SUPPL-2 ACETAMINOPHEN; HYDROCODONE BITARTRATE TRIS PHARMA INC Manufacturing (CMC) Approval
03/15/2016 OLANZAPINE
ANDA #203333		 ORIG-1 OLANZAPINE CHARTWELL MOLECULAR Approval
03/15/2016 LINEZOLID
ANDA #204764		 ORIG-1 LINEZOLID FRESENIUS KABI USA Approval
03/15/2016 MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #206485		 ORIG-1 MAGNESIUM SULFATE FRESENIUS KABI USA Approval
03/16/2016 PRISTIQ
NDA #021992		 SUPPL-41 DESVENLAFAXINE SUCCINATE PF PRISM CV Manufacturing (CMC) Approval
03/16/2016 TROKENDI XR
NDA #201635		 SUPPL-12 TOPIRAMATE SUPERNUS PHARMS Manufacturing (CMC) Approval
03/16/2016 TUDORZA PRESSAIR
NDA #202450		 SUPPL-6 ACLIDINIUM BROMIDE COVIS Labeling Approval
03/16/2016 OLANZAPINE
ANDA #203456		 ORIG-1 OLANZAPINE CHARTWELL MOLECULAR Approval
03/16/2016 DEXTROAMPHETAMINE SULFATE
ANDA #204330		 ORIG-1 DEXTROAMPHETAMINE SULFATE NOVEL LABS INC Approval
03/16/2016 CELECOXIB
ANDA #204590		 ORIG-1 CELECOXIB MACLEODS PHARMS LTD Approval
03/16/2016 DECITABINE
NDA #205582		 SUPPL-3 DECITABINE SUN PHARM Manufacturing (CMC) Approval
03/17/2016 XYLOCAINE
NDA #006488		 SUPPL-91 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/17/2016 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-91 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/17/2016 CYTOVENE
NDA #019661		 SUPPL-35 GANCICLOVIR SODIUM CHEPLAPHARM Manufacturing (CMC) Approval
03/17/2016 NUTROPIN AQ
BLA #020522		 SUPPL-58 SOMATROPIN GENENTECH Approval
03/17/2016 NUTROPIN AQ NUSPIN
BLA #020522		 SUPPL-58 SOMATROPIN GENENTECH Approval
03/17/2016 NUTROPIN AQ PEN
BLA #020522		 SUPPL-58 SOMATROPIN GENENTECH Approval
03/17/2016 LIDODERM
NDA #020612		 SUPPL-13 LIDOCAINE TEIKOKU PHARMA USA Manufacturing (CMC) Approval
03/17/2016 INFUVITE ADULT
NDA #021163		 SUPPL-32 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 Labeling Approval
03/17/2016 INFUVITE PEDIATRIC
NDA #021265		 SUPPL-30 ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K SANDOZ CANADA INC Labeling Approval
03/17/2016 INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
NDA #021265		 SUPPL-30 ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K SANDOZ CANADA INC Labeling Approval
03/17/2016 OMNARIS
NDA #022004		 SUPPL-15 CICLESONIDE COVIS Labeling Approval
03/17/2016 OSENI
NDA #022426		 SUPPL-4 ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/17/2016 HERCEPTIN
BLA #103792		 SUPPL-5330 TRASTUZUMAB GENENTECH Approval
03/17/2016 INVOKAMET
NDA #204353		 SUPPL-8 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Manufacturing (CMC) Approval
03/17/2016 VARDENAFIL HYDROCHLORIDE
ANDA #204786		 ORIG-1 VARDENAFIL HYDROCHLORIDE PAR PHARM INC Tentative Approval
03/17/2016 LACOSAMIDE
ANDA #204980		 ORIG-1 LACOSAMIDE GLENMARK PHARMS LTD Tentative Approval
03/17/2016 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #205867		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE EUGIA PHARMA Approval
03/17/2016 DUTASTERIDE
ANDA #206373		 ORIG-1 DUTASTERIDE ACELLA Approval
03/17/2016 DESIPRAMINE HYDROCHLORIDE
ANDA #208105		 ORIG-1 DESIPRAMINE HYDROCHLORIDE AMNEAL PHARMS CO Approval
03/18/2016 PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017385		 SUPPL-62 DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
03/18/2016 CAPEX
NDA #020001		 SUPPL-14 FLUOCINOLONE ACETONIDE GALDERMA LABS LP Manufacturing (CMC) Approval
03/18/2016 VANOS
NDA #021758		 SUPPL-18 FLUOCINONIDE BAUSCH Manufacturing (CMC) Approval
03/18/2016 ORAVERSE
NDA #022159		 SUPPL-11 PHENTOLAMINE MESYLATE SEPTODONT HOLDING Efficacy Approval
03/18/2016 TACLONEX
NDA #022185		 SUPPL-23 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
03/18/2016 TACLONEX
NDA #022185		 SUPPL-23 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
03/18/2016 ANTHIM
BLA #125509		 ORIG-1 OBILTOXAXIMAB ELUSYS THERAPEUTICS INC Approval
03/18/2016 PANTOPRAZOLE SODIUM
ANDA #202882		 SUPPL-1 PANTOPRAZOLE SODIUM HETERO LABS LTD V Labeling Approval
03/18/2016 PANTOPRAZOLE SODIUM
ANDA #202882		 SUPPL-3 PANTOPRAZOLE SODIUM HETERO LABS LTD V Labeling Approval
03/18/2016 ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST
ANDA #202999		 ORIG-1 ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST TEVA PHARMS USA Tentative Approval
03/18/2016 XOFIGO
NDA #203971		 SUPPL-7 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Labeling Approval
03/18/2016 JARDIANCE
NDA #204629		 SUPPL-5 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Efficacy Approval
03/18/2016 OMTRYG
NDA #204977		 SUPPL-6 OMEGA-3-ACID ETHYL ESTERS TYPE A OSMOTICA PHARM US Manufacturing (CMC) Approval
03/18/2016 VALGANCICLOVIR HYDROCHLORIDE
ANDA #205166		 ORIG-1 VALGANCICLOVIR HYDROCHLORIDE HETERO LABS LTD V Approval
03/18/2016 NAPROXEN SODIUM
ANDA #205497		 ORIG-1 NAPROXEN SODIUM AUROBINDO PHARMA LTD Approval
03/18/2016 ORKAMBI
NDA #206038		 SUPPL-2 IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC Manufacturing (CMC) Approval
03/18/2016 STIOLTO RESPIMAT
NDA #206756		 SUPPL-2 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Efficacy Approval
03/18/2016 DICLOFENAC SODIUM
ANDA #208077		 ORIG-1 DICLOFENAC SODIUM AMNEAL PHARMS Approval
03/21/2016 LOPRESSOR
NDA #017963		 SUPPL-71 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
03/21/2016 ANGIOMAX
NDA #020873		 SUPPL-36 BIVALIRUDIN SANDOZ Labeling Approval
03/21/2016 ZANTAC 150
NDA #021698		 SUPPL-22 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
03/21/2016 LETAIRIS
NDA #022081		 SUPPL-35 AMBRISENTAN GILEAD Manufacturing (CMC) Approval
03/21/2016 CARVEDILOL
ANDA #078251		 SUPPL-14 CARVEDILOL GLENMARK PHARMS LTD Labeling Approval
03/21/2016 PROCYSBI
NDA #203389		 SUPPL-16 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
03/21/2016 VASOSTRICT
NDA #204485		 SUPPL-3 VASOPRESSIN ENDO OPERATIONS Manufacturing (CMC) Approval
03/21/2016 IMBRUVICA
NDA #205552		 SUPPL-6 IBRUTINIB PHARMACYCLICS LLC Manufacturing (CMC) Approval
03/22/2016 NORMOSOL-R IN PLASTIC CONTAINER
NDA #017586		 SUPPL-129 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE ICU MEDICAL INC Manufacturing (CMC) Approval
03/22/2016 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-41 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Manufacturing (CMC) Approval
03/22/2016 LEXIVA
NDA #021548		 SUPPL-37 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
03/22/2016 LEXIVA
NDA #022116		 SUPPL-21 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
03/22/2016 PRAVASTATIN SODIUM
ANDA #077904		 ORIG-2 PRAVASTATIN SODIUM CIPLA Approval
03/22/2016 MOMETASONE FUROATE
ANDA #091161		 ORIG-1 MOMETASONE FUROATE APOTEX Approval
03/22/2016 PERJETA
BLA #125409		 SUPPL-109 PERTUZUMAB GENENTECH Approval
03/22/2016 TALTZ
BLA #125521		 ORIG-1 IXEKIZUMAB ELI LILLY AND CO Approval
03/22/2016 BINOSTO
NDA #202344		 SUPPL-10 ALENDRONATE SODIUM RADIUS Labeling Approval
03/22/2016 LEVALBUTEROL HYDROCHLORIDE
ANDA #203653		 ORIG-1 LEVALBUTEROL HYDROCHLORIDE RITEDOSE CORP Approval
03/22/2016 ACETAMINOPHEN
ANDA #204052		 ORIG-1 ACETAMINOPHEN SANDOZ Approval
03/22/2016 OPSUMIT
NDA #204410		 SUPPL-5 MACITENTAN ACTELION Manufacturing (CMC) Approval
03/22/2016 RALOXIFENE HYDROCHLORIDE
ANDA #204491		 ORIG-1 RALOXIFENE HYDROCHLORIDE GLENMARK PHARMS LTD Approval
03/23/2016 DROXIA
NDA #016295		 SUPPL-47 HYDROXYUREA CHEPLAPHARM Labeling Approval
03/23/2016 DROXIA
NDA #016295		 SUPPL-48 HYDROXYUREA CHEPLAPHARM Labeling Approval
03/23/2016 HYDREA
NDA #016295		 SUPPL-47 HYDROXYUREA CHEPLAPHARM Labeling Approval
03/23/2016 HYDREA
NDA #016295		 SUPPL-48 HYDROXYUREA CHEPLAPHARM Labeling Approval
03/23/2016 DEXTROSE 20% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-72 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/23/2016 DEXTROSE 30% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-72 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/23/2016 DEXTROSE 40% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-72 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/23/2016 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-72 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/23/2016 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-72 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/23/2016 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-72 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/23/2016 ALPHAGAN
NDA #020490		 SUPPL-8 BRIMONIDINE TARTRATE ALLERGAN Labeling Approval
03/23/2016 ALPHAGAN
NDA #020613		 SUPPL-31 BRIMONIDINE TARTRATE ALLERGAN Labeling Approval
03/23/2016 ALLEGRA ALLERGY
NDA #020872		 SUPPL-37 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
03/23/2016 ALLEGRA HIVES
NDA #020872		 SUPPL-37 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
03/23/2016 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-37 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
03/23/2016 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-37 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
03/23/2016 UROXATRAL
NDA #021287		 SUPPL-19 ALFUZOSIN HYDROCHLORIDE CONCORDIA Manufacturing (CMC) Approval
03/23/2016 VIBATIV
NDA #022110		 SUPPL-13 TELAVANCIN HYDROCHLORIDE CUMBERLAND REMS Approval
03/23/2016 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040779		 SUPPL-5 ACETAMINOPHEN; CODEINE PHOSPHATE AMNEAL PHARMS NY Labeling Approval
03/23/2016 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-95 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
03/23/2016 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-96 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
03/23/2016 ZIANA
NDA #050802		 SUPPL-16 CLINDAMYCIN PHOSPHATE; TRETINOIN BAUSCH Manufacturing (CMC) Approval
03/23/2016 EPIRUBICIN HYDROCHLORIDE
ANDA #065445		 SUPPL-8 EPIRUBICIN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
03/23/2016 ESCITALOPRAM OXALATE
ANDA #090939		 SUPPL-13 ESCITALOPRAM OXALATE TORRENT PHARMS LTD Manufacturing (CMC) Approval
03/23/2016 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #091332		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Approval
03/23/2016 VORICONAZOLE
ANDA #206398		 ORIG-1 VORICONAZOLE ALMAJECT Approval
03/23/2016 CINQAIR
BLA #761033		 ORIG-1 RESLIZUMAB TEVA RESPIRATORY LLC Approval
03/24/2016 DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
NDA #017484		 SUPPL-72 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/24/2016 EXIDINE
NDA #019422		 SUPPL-45 CHLORHEXIDINE GLUCONATE XTTRIUM Manufacturing (CMC) Approval
03/24/2016 ROWASA
NDA #019618		 SUPPL-22 MESALAMINE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/24/2016 SFROWASA
NDA #019618		 SUPPL-22 MESALAMINE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/24/2016 BETOPTIC S
NDA #019845		 SUPPL-26 BETAXOLOL HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
03/24/2016 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-41 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
03/24/2016 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-41 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
03/24/2016 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-41 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
03/24/2016 COLGATE TOTAL
NDA #020231		 SUPPL-75 SODIUM FLUORIDE; TRICLOSAN COLGATE PALMOLIVE Labeling Approval
03/24/2016 PLAVIX
NDA #020839		 SUPPL-63 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/24/2016 PHOSLO
NDA #021160		 SUPPL-31 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
03/24/2016 PHOSLO GELCAPS
NDA #021160		 SUPPL-31 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
03/24/2016 SPIRIVA
NDA #021395		 SUPPL-41 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
03/24/2016 ABRAXANE
NDA #021660		 SUPPL-43 PACLITAXEL BRISTOL-MYERS Manufacturing (CMC) Approval
03/24/2016 AMRIX
NDA #021777		 SUPPL-13 CYCLOBENZAPRINE HYDROCHLORIDE TEVA PHARMS INTL Manufacturing (CMC) Approval
03/24/2016 VENLAFAXINE HYDROCHLORIDE
NDA #022104		 SUPPL-12 VENLAFAXINE HYDROCHLORIDE OSMOTICA PHARM US Manufacturing (CMC) Approval
03/24/2016 ULESFIA
NDA #022129		 SUPPL-6 BENZYL ALCOHOL SHIONOGI INC Manufacturing (CMC) Approval
03/24/2016 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-71 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
03/24/2016 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-31 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
03/24/2016 CEFUROXIME AXETIL
ANDA #065069		 SUPPL-13 CEFUROXIME AXETIL APOTEX Labeling Approval
03/24/2016 CEFUROXIME AXETIL
ANDA #065135		 SUPPL-17 CEFUROXIME AXETIL LUPIN Labeling Approval
03/24/2016 CEFUROXIME AXETIL
ANDA #065135		 SUPPL-18 CEFUROXIME AXETIL LUPIN Labeling Approval
03/24/2016 CEFUROXIME AXETIL
ANDA #065359		 SUPPL-5 CEFUROXIME AXETIL ANDA REPOSITORY Labeling Approval
03/24/2016 CEFUROXIME AXETIL
ANDA #065359		 SUPPL-6 CEFUROXIME AXETIL ANDA REPOSITORY Labeling Approval
03/24/2016 CEFUROXIME AXETIL
ANDA #065496		 SUPPL-4 CEFUROXIME AXETIL ALKEM LABS LTD Labeling Approval
03/24/2016 LISINOPRIL
ANDA #075752		 SUPPL-40 LISINOPRIL HERITAGE PHARMA Labeling Approval
03/24/2016 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076631		 SUPPL-29 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SANDOZ Labeling Approval
03/24/2016 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076688		 SUPPL-13 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE AUROBINDO PHARMA USA Labeling Approval
03/24/2016 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077483		 SUPPL-8 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SUN PHARM INDS LTD Labeling Approval
03/24/2016 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
ANDA #077559		 SUPPL-5 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE CIPLA Labeling Approval
03/24/2016 LISINOPRIL
ANDA #078402		 SUPPL-7 LISINOPRIL WOCKHARDT BIO AG Labeling Approval
03/24/2016 LISINOPRIL
ANDA #078402		 SUPPL-8 LISINOPRIL WOCKHARDT BIO AG Labeling Approval
03/24/2016 ACARBOSE
ANDA #078470		 SUPPL-4 ACARBOSE HIKMA Labeling Approval
03/24/2016 LITHIUM CARBONATE
ANDA #078763		 SUPPL-5 LITHIUM CARBONATE MYLAN Labeling Approval
03/24/2016 LEVALBUTEROL HYDROCHLORIDE
ANDA #090297		 SUPPL-3 LEVALBUTEROL HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
03/24/2016 LEVALBUTEROL HYDROCHLORIDE
ANDA #090297		 SUPPL-4 LEVALBUTEROL HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
03/24/2016 LEVALBUTEROL HYDROCHLORIDE
ANDA #090297		 SUPPL-5 LEVALBUTEROL HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
03/24/2016 ACARBOSE
ANDA #091053		 SUPPL-1 ACARBOSE DASH PHARMS Labeling Approval
03/24/2016 ACARBOSE
ANDA #091053		 SUPPL-3 ACARBOSE DASH PHARMS Labeling Approval
03/24/2016 FAMCICLOVIR
ANDA #091114		 SUPPL-4 FAMCICLOVIR AUROBINDO PHARMA LTD Labeling Approval
03/24/2016 FAMCICLOVIR
ANDA #091114		 SUPPL-5 FAMCICLOVIR AUROBINDO PHARMA LTD Labeling Approval
03/24/2016 ZOLEDRONIC ACID
ANDA #091170		 SUPPL-5 ZOLEDRONIC ACID BRECKENRIDGE Labeling Approval
03/24/2016 OXYCODONE HYDROCHLORIDE
ANDA #091313		 SUPPL-1 OXYCODONE HYDROCHLORIDE DR REDDYS LABS SA Manufacturing (CMC) Approval
03/24/2016 ALOSETRON HYDROCHLORIDE
ANDA #200652		 SUPPL-3 ALOSETRON HYDROCHLORIDE HIKMA REMS Approval
03/24/2016 EDARBI
NDA #200796		 SUPPL-7 AZILSARTAN KAMEDOXOMIL AZURITY Manufacturing (CMC) Approval
03/24/2016 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201192		 SUPPL-2 HYDROCHLOROTHIAZIDE; TELMISARTAN TORRENT Labeling Approval
03/24/2016 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201192		 SUPPL-3 HYDROCHLOROTHIAZIDE; TELMISARTAN TORRENT Labeling Approval
03/24/2016 TUDORZA PRESSAIR
NDA #202450		 SUPPL-7 ACLIDINIUM BROMIDE COVIS Manufacturing (CMC) Approval
03/24/2016 ABILIFY MAINTENA KIT
NDA #202971		 SUPPL-7 ARIPIPRAZOLE OTSUKA PHARM CO LTD Manufacturing (CMC) Approval
03/24/2016 PIPERACILLIN AND TAZOBACTAM
ANDA #203557		 SUPPL-3 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Manufacturing (CMC) Approval
03/24/2016 DIAZEPAM
ANDA #204433		 SUPPL-2 DIAZEPAM CHARTWELL MOLECULAR Labeling Approval
03/24/2016 VALSARTAN
ANDA #204821		 SUPPL-1 VALSARTAN PRINSTON INC Labeling Approval
03/24/2016 OTREXUP
NDA #204824		 SUPPL-4 METHOTREXATE OTTER PHARMS Manufacturing (CMC) Approval
03/24/2016 OTREXUP PFS
NDA #204824		 SUPPL-4 METHOTREXATE OTTER PHARMS Manufacturing (CMC) Approval
03/24/2016 TELMISARTAN
ANDA #205150		 SUPPL-1 TELMISARTAN INVENTIA Manufacturing (CMC) Approval
03/24/2016 MOXIFLOXACIN HYDROCHLORIDE
NDA #205572		 SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/24/2016 POTASSIUM IODIDE
ANDA #206211		 ORIG-1 POTASSIUM IODIDE MISSION PHARMACAL Approval
03/24/2016 ARISTADA
NDA #207533		 SUPPL-1 ARIPIPRAZOLE LAUROXIL ALKERMES INC Manufacturing (CMC) Approval
03/25/2016 KLONOPIN
NDA #017533		 SUPPL-55 CLONAZEPAM CHEPLAPHARM Labeling Approval
03/25/2016 IMITREX
NDA #020626		 SUPPL-26 SUMATRIPTAN GLAXOSMITHKLINE Manufacturing (CMC) Approval
03/25/2016 OXYCONTIN
NDA #022272		 SUPPL-31 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Manufacturing (CMC) Approval
03/25/2016 SULFASALAZINE
ANDA #040349		 SUPPL-13 SULFASALAZINE NUVO PHARMS INC Labeling Approval
03/25/2016 SULFASALAZINE
ANDA #040349		 SUPPL-14 SULFASALAZINE NUVO PHARMS INC Labeling Approval
03/25/2016 ZIANA
NDA #050802		 SUPPL-17 CLINDAMYCIN PHOSPHATE; TRETINOIN BAUSCH Manufacturing (CMC) Approval
03/25/2016 ACANYA
NDA #050819		 SUPPL-16 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
03/25/2016 ONEXTON
NDA #050819		 SUPPL-16 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
03/25/2016 ETODOLAC
ANDA #074892		 SUPPL-10 ETODOLAC WATSON LABS Labeling Approval
03/25/2016 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #076560		 SUPPL-6 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE LGM PHARMA Labeling Approval
03/25/2016 CILOSTAZOL
ANDA #077024		 SUPPL-7 CILOSTAZOL HIKMA Labeling Approval
03/25/2016 CILOSTAZOL
ANDA #077024		 SUPPL-8 CILOSTAZOL HIKMA Labeling Approval
03/25/2016 CARVEDILOL
ANDA #077474		 SUPPL-2 CARVEDILOL CHARTWELL MOLECULAR Labeling Approval
03/25/2016 CARVEDILOL
ANDA #077614		 SUPPL-15 CARVEDILOL ZYDUS PHARMS USA INC Labeling Approval
03/25/2016 FAMCICLOVIR
ANDA #090128		 SUPPL-3 FAMCICLOVIR HIKMA Labeling Approval
03/25/2016 DAPTOMYCIN
ANDA #091039		 ORIG-1 DAPTOMYCIN TEVA PHARMS USA Approval
03/25/2016 ZOLEDRONIC ACID
NDA #203231		 SUPPL-11 ZOLEDRONIC ACID INFORLIFE Labeling Approval
03/25/2016 ACYCLOVIR
ANDA #204313		 ORIG-1 ACYCLOVIR CADILA Approval
03/25/2016 RIVASTIGMINE TARTRATE
ANDA #204572		 ORIG-1 RIVASTIGMINE TARTRATE AUROBINDO PHARMA Approval
03/25/2016 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #204848		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Approval
03/25/2016 LEVONORGESTREL
ANDA #207044		 ORIG-1 LEVONORGESTREL GLENMARK PHARMS LTD Approval
03/27/2016 JETREA
BLA #125422		 SUPPL-37 OCRIPLASMIN THROMBOGENICS, INC Approval
03/28/2016 OXYCONTIN
NDA #022272		 SUPPL-32 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Manufacturing (CMC) Approval
03/28/2016 OXYCODONE AND ACETAMINOPHEN
ANDA #040203		 SUPPL-5 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
03/28/2016 OXYCODONE AND ACETAMINOPHEN
ANDA #040203		 SUPPL-6 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
03/28/2016 OXYCODONE AND ACETAMINOPHEN
ANDA #040800		 SUPPL-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
03/28/2016 ZOLPIDEM TARTRATE
ANDA #078179		 SUPPL-12 ZOLPIDEM TARTRATE ACTAVIS ELIZABETH Labeling Approval
03/28/2016 RAMIPRIL
ANDA #091604		 SUPPL-7 RAMIPRIL AUROBINDO PHARMA LTD Labeling Approval
03/28/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE ANCHEN PHARMS Labeling Approval
03/28/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 SUPPL-8 PRAMIPEXOLE DIHYDROCHLORIDE ANCHEN PHARMS Labeling Approval
03/28/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 SUPPL-10 PRAMIPEXOLE DIHYDROCHLORIDE ANCHEN PHARMS Labeling Approval
03/28/2016 INVOKANA
NDA #204042		 SUPPL-11 CANAGLIFLOZIN JANSSEN PHARMS Labeling Approval
03/28/2016 POTASSIUM CHLORIDE
ANDA #204210		 ORIG-1 POTASSIUM CHLORIDE CHARTWELL MOLECULAR Approval
03/28/2016 INVOKAMET
NDA #204353		 SUPPL-10 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
03/28/2016 CARBOPLATIN
ANDA #205487		 ORIG-1 CARBOPLATIN EUGIA PHARMA Approval
03/28/2016 DEXTROAMPHETAMINE SULFATE
ANDA #206588		 ORIG-1 DEXTROAMPHETAMINE SULFATE NESHER PHARMS Approval
03/29/2016 STERILE WATER FOR INJECTION
NDA #018801		 SUPPL-39 STERILE WATER FOR INJECTION HOSPIRA Manufacturing (CMC) Approval
03/29/2016 ACCOLATE
NDA #020547		 SUPPL-34 ZAFIRLUKAST STRIDES PHARMA Manufacturing (CMC) Approval
03/29/2016 MIFEPREX
NDA #020687		 SUPPL-20 MIFEPRISTONE DANCO LABS LLC Efficacy Approval
03/29/2016 ZOMETA
NDA #021223		 SUPPL-34 ZOLEDRONIC ACID NOVARTIS Labeling Approval
03/29/2016 FANAPT
NDA #022192		 SUPPL-16 ILOPERIDONE VANDA PHARMS INC Manufacturing (CMC) Approval
03/29/2016 COLY-MYCIN S
NDA #050356		 SUPPL-56 COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE ENDO OPERATIONS Manufacturing (CMC) Approval
03/29/2016 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-51 DOXORUBICIN HYDROCHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
03/29/2016 ALENDRONATE SODIUM
ANDA #075710		 SUPPL-18 ALENDRONATE SODIUM IMPAX LABS INC Labeling Approval
03/29/2016 CARVEDILOL
ANDA #076989		 SUPPL-4 CARVEDILOL SUN PHARM INDS LTD Labeling Approval
03/29/2016 CILOSTAZOL
ANDA #077722		 SUPPL-1 CILOSTAZOL CHARTWELL RX Labeling Approval
03/29/2016 GALANTAMINE HYDROBROMIDE
ANDA #077781		 SUPPL-2 GALANTAMINE HYDROBROMIDE APOTEX INC Labeling Approval
03/29/2016 GALANTAMINE HYDROBROMIDE
ANDA #077781		 SUPPL-3 GALANTAMINE HYDROBROMIDE APOTEX INC Labeling Approval
03/29/2016 GALANTAMINE HYDROBROMIDE
ANDA #077781		 SUPPL-4 GALANTAMINE HYDROBROMIDE APOTEX INC Labeling Approval
03/29/2016 CILOSTAZOL
ANDA #077831		 SUPPL-1 CILOSTAZOL CHARTWELL RX Labeling Approval
03/29/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088617		 SUPPL-44 HYDROXYZINE HYDROCHLORIDE PLIVA Labeling Approval
03/29/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088618		 SUPPL-44 HYDROXYZINE HYDROCHLORIDE PLIVA Labeling Approval
03/29/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088619		 SUPPL-45 HYDROXYZINE HYDROCHLORIDE PLIVA Labeling Approval
03/29/2016 LATUDA
NDA #200603		 SUPPL-23 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Manufacturing (CMC) Approval
03/29/2016 CLONIDINE HYDROCHLORIDE
ANDA #202984		 SUPPL-4 CLONIDINE HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
03/29/2016 CLONIDINE HYDROCHLORIDE
ANDA #202984		 SUPPL-6 CLONIDINE HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
03/29/2016 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203010		 SUPPL-1 HYDROCHLOROTHIAZIDE; TELMISARTAN ALEMBIC Labeling Approval
03/29/2016 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203010		 SUPPL-2 HYDROCHLOROTHIAZIDE; TELMISARTAN ALEMBIC Labeling Approval
03/29/2016 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203010		 SUPPL-4 HYDROCHLOROTHIAZIDE; TELMISARTAN ALEMBIC Labeling Approval
03/29/2016 ACETAZOLAMIDE
ANDA #204691		 ORIG-1 ACETAZOLAMIDE NOSTRUM LABS INC Approval
03/29/2016 VANCOMYCIN HYDROCHLORIDE
ANDA #205779		 ORIG-1 VANCOMYCIN HYDROCHLORIDE EUGIA PHARMA Approval
03/29/2016 FAYOSIM
ANDA #205943		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Approval
03/29/2016 VISTOGARD
NDA #208159		 SUPPL-1 URIDINE TRIACETATE BTG INTL Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040010		 SUPPL-11 HYDROXYZINE HYDROCHLORIDE HIKMA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040391		 SUPPL-8 HYDROXYZINE HYDROCHLORIDE PAI HOLDINGS PHARM Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040580		 SUPPL-11 HYDROXYZINE HYDROCHLORIDE PRINSTON INC Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040604		 SUPPL-6 HYDROXYZINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040786		 SUPPL-12 HYDROXYZINE HYDROCHLORIDE KVK TECH Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040804		 SUPPL-4 HYDROXYZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040805		 SUPPL-2 HYDROXYZINE HYDROCHLORIDE HETERO LABS LTD III Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040808		 SUPPL-5 HYDROXYZINE HYDROCHLORIDE AMNEAL PHARM Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040812		 SUPPL-5 HYDROXYZINE HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040840		 SUPPL-9 HYDROXYZINE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #040899		 SUPPL-4 HYDROXYZINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
03/30/2016 MINOXIDIL (FOR MEN)
ANDA #075357		 SUPPL-24 MINOXIDIL L PERRIGO CO Labeling Approval
03/30/2016 MINOXIDIL (FOR WOMEN)
ANDA #075357		 SUPPL-24 MINOXIDIL L PERRIGO CO Labeling Approval
03/30/2016 OMEPRAZOLE
ANDA #076515		 SUPPL-20 OMEPRAZOLE SANDOZ Labeling Approval
03/30/2016 OMEPRAZOLE
ANDA #076515		 SUPPL-21 OMEPRAZOLE SANDOZ Labeling Approval
03/30/2016 OMEPRAZOLE
ANDA #076515		 SUPPL-24 OMEPRAZOLE SANDOZ Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #081149		 SUPPL-12 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #081150		 SUPPL-12 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #081151		 SUPPL-14 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #085778		 SUPPL-53 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #085779		 SUPPL-95 HYDROXYZINE HYDROCHLORIDE DR REDDYS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #086880		 SUPPL-40 HYDROXYZINE HYDROCHLORIDE ANIMA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087294		 SUPPL-27 HYDROXYZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087329		 SUPPL-21 HYDROXYZINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087408		 SUPPL-25 HYDROXYZINE HYDROCHLORIDE AM REGENT Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087602		 SUPPL-32 HYDROXYZINE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087603		 SUPPL-30 HYDROXYZINE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087604		 SUPPL-30 HYDROXYZINE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087862		 SUPPL-16 HYDROXYZINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #087871		 SUPPL-27 HYDROXYZINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088348		 SUPPL-50 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088349		 SUPPL-48 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088350		 SUPPL-46 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088617		 SUPPL-45 HYDROXYZINE HYDROCHLORIDE PLIVA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088618		 SUPPL-45 HYDROXYZINE HYDROCHLORIDE PLIVA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #088619		 SUPPL-46 HYDROXYZINE HYDROCHLORIDE PLIVA Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #089381		 SUPPL-34 HYDROXYZINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #089382		 SUPPL-33 HYDROXYZINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #089383		 SUPPL-32 HYDROXYZINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #091176		 SUPPL-6 HYDROXYZINE HYDROCHLORIDE RISING Labeling Approval
03/30/2016 NICOTINE POLACRILEX
ANDA #091349		 SUPPL-8 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #201674		 SUPPL-3 HYDROXYZINE HYDROCHLORIDE LANNETT CO INC Labeling Approval
03/30/2016 INLYTA
NDA #202324		 SUPPL-4 AXITINIB PF PRISM CV Manufacturing (CMC) Approval
03/30/2016 IBUPROFEN LYSINE
ANDA #202402		 ORIG-1 IBUPROFEN LYSINE XGEN PHARMS Approval
03/30/2016 GATTEX KIT
NDA #203441		 SUPPL-7 TEDUGLUTIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/30/2016 RILUZOLE
ANDA #204048		 ORIG-1 RILUZOLE ALKEM LABS LTD Approval
03/30/2016 HYDROXYZINE HYDROCHLORIDE
ANDA #204279		 SUPPL-2 HYDROXYZINE HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
03/30/2016 PANTOPRAZOLE SODIUM
ANDA #205675		 ORIG-1 PANTOPRAZOLE SODIUM EUGIA PHARMA Approval
03/30/2016 DEFITELIO
NDA #208114		 ORIG-1 DEFIBROTIDE SODIUM JAZZ PHARMS INC Type 1 - New Molecular Entity Approval
03/31/2016 SUSTIVA
NDA #020972		 SUPPL-49 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
03/31/2016 SUSTIVA
NDA #021360		 SUPPL-38 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
03/31/2016 VIBRAMYCIN
NDA #050006		 SUPPL-87 DOXYCYCLINE PFIZER Labeling Approval
03/31/2016 VIBRAMYCIN
NDA #050007		 SUPPL-30 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
03/31/2016 VIBRAMYCIN
NDA #050442		 SUPPL-18 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
03/31/2016 VIBRAMYCIN
NDA #050480		 SUPPL-54 DOXYCYCLINE CALCIUM PFIZER Labeling Approval
03/31/2016 VIBRA-TABS
NDA #050533		 SUPPL-43 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
03/31/2016 ESCITALOPRAM OXALATE
ANDA #202754		 ORIG-1 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Approval
03/31/2016 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203630		 ORIG-2 HYDROCHLOROTHIAZIDE; IRBESARTAN AUROBINDO PHARMA LTD Approval
03/31/2016 LUMASON
NDA #203684		 SUPPL-1 SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES BRACCO Efficacy Approval
03/31/2016 VALGANCICLOVIR HYDROCHLORIDE
ANDA #204750		 ORIG-1 VALGANCICLOVIR HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
03/31/2016 TAPENTADOL
ANDA #205015		 ORIG-1 TAPENTADOL ALKEM LABS LTD Tentative Approval
03/31/2016 OXYCODONE HYDROCHLORIDE
ANDA #205177		 ORIG-1 OXYCODONE HYDROCHLORIDE ANI PHARMS Approval
03/31/2016 PREZCOBIX
NDA #205395		 SUPPL-1 COBICISTAT; DARUNAVIR JANSSEN PRODS Labeling Approval
03/31/2016 VANCOMYCIN HYDROCHLORIDE
ANDA #205780		 ORIG-1 VANCOMYCIN HYDROCHLORIDE EUGIA PHARMA Approval
03/31/2016 TAPENTADOL HYDROCHLORIDE
ANDA #206657		 ORIG-1 TAPENTADOL HYDROCHLORIDE ACTAVIS LABS UT INC Tentative Approval
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