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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 2018

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 September 20, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/01/2018 IOPIDINE
NDA #019779		 SUPPL-25 APRACLONIDINE HYDROCHLORIDE HARROW EYE Labeling Approval
03/01/2018 IOPIDINE
NDA #020258		 SUPPL-30 APRACLONIDINE HYDROCHLORIDE HARROW EYE Labeling Approval
03/01/2018 ASCLERA
NDA #021201		 SUPPL-2 POLIDOCANOL CHEMISCH FBRK KRSSLR Labeling Approval
03/01/2018 DEPO-SUBQ PROVERA 104
NDA #021583		 SUPPL-17 MEDROXYPROGESTERONE ACETATE PFIZER Labeling Approval
03/01/2018 SOTRADECOL
ANDA #040541		 SUPPL-14 SODIUM TETRADECYL SULFATE MYLAN INSTITUTIONAL Labeling Approval
03/01/2018 SKYLA
NDA #203159		 SUPPL-10 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
03/01/2018 KYLEENA
NDA #208224		 SUPPL-1 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
03/02/2018 NEBIVOLOL HYDROCHLORIDE
ANDA #203966		 ORIG-1 NEBIVOLOL HYDROCHLORIDE TORRENT Approval
03/02/2018 OTIPRIO
NDA #207986		 SUPPL-2 CIPROFLOXACIN ALK ABELLO Efficacy Approval
03/02/2018 ARMONAIR DIGIHALER
NDA #208798		 SUPPL-2 FLUTICASONE PROPIONATE TEVA PHARM Labeling Approval
03/02/2018 ARMONAIR RESPICLICK
NDA #208798		 SUPPL-2 FLUTICASONE PROPIONATE TEVA PHARM Labeling Approval
03/02/2018 AIRDUO DIGIHALER
NDA #208799		 SUPPL-1 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE TEVA PHARM Labeling Approval
03/02/2018 AIRDUO RESPICLICK
NDA #208799		 SUPPL-1 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE TEVA PHARM Labeling Approval
03/02/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #209498		 ORIG-1 TENOFOVIR DISOPROXIL FUMARATE QILU Approval
03/02/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #209753		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE BIONPHARMA Approval
03/04/2018 NUPLAZID
NDA #207318		 SUPPL-2 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Labeling Approval
03/04/2018 NUPLAZID
NDA #207318		 SUPPL-4 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Labeling Approval
03/05/2018 MAGNESIUM SULFATE
NDA #019316		 SUPPL-24 MAGNESIUM SULFATE FRESENIUS KABI USA Labeling Approval
03/05/2018 ISENTRESS
NDA #022145		 SUPPL-38 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
03/05/2018 ISENTRESS HD
NDA #022145		 SUPPL-38 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-48 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-49 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-50 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-51 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-52 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-61 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-62 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-64 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-65 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 OPDIVO
BLA #125554		 SUPPL-66 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/05/2018 LATUDA
NDA #200603		 SUPPL-29 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Efficacy Approval
03/05/2018 ISENTRESS
NDA #203045		 SUPPL-15 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
03/05/2018 FUROSEMIDE
ANDA #203428		 SUPPL-8 FUROSEMIDE AVET LIFESCIENCES Manufacturing (CMC) Approval
03/05/2018 OXALIPLATIN
ANDA #204880		 ORIG-1 OXALIPLATIN ACTAVIS Approval
03/05/2018 ISENTRESS
NDA #205786		 SUPPL-7 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
03/05/2018 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #207602		 ORIG-1 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN PERRIGO R AND D Approval
03/05/2018 RANITIDINE HYDROCHLORIDE
ANDA #209160		 ORIG-1 RANITIDINE HYDROCHLORIDE STRIDES PHARMA Approval
03/05/2018 DOLUTEGRAVIR SODIUM
ANDA #209658		 ORIG-1 DOLUTEGRAVIR SODIUM CIPLA LTD Tentative Approval
03/05/2018 POTASSIUM CITRATE
ANDA #209758		 ORIG-1 POTASSIUM CITRATE TEVA PHARMS USA INC Approval
03/05/2018 ESTRADIOL
ANDA #209767		 ORIG-1 ESTRADIOL ALVOGEN Approval
03/05/2018 SUBLOCADE
NDA #209819		 SUPPL-1 BUPRENORPHINE INDIVIOR Labeling Approval
03/06/2018 ALDACTONE
NDA #012151		 SUPPL-75 SPIRONOLACTONE PFIZER Labeling Approval
03/06/2018 SKELAXIN
NDA #013217		 SUPPL-57 METAXALONE KING PHARMS Labeling Approval
03/06/2018 DEPAKENE
NDA #018081		 SUPPL-68 VALPROIC ACID ABBVIE Labeling Approval
03/06/2018 DEPAKENE
NDA #018082		 SUPPL-51 VALPROIC ACID ABBVIE Labeling Approval
03/06/2018 DEPAKOTE
NDA #018723		 SUPPL-60 DIVALPROEX SODIUM ABBVIE Labeling Approval
03/06/2018 DEPAKOTE
NDA #019680		 SUPPL-47 DIVALPROEX SODIUM ABBVIE Labeling Approval
03/06/2018 DEPACON
NDA #020593		 SUPPL-38 VALPROATE SODIUM ABBVIE Labeling Approval
03/06/2018 LEVULAN
NDA #020965		 SUPPL-15 AMINOLEVULINIC ACID HYDROCHLORIDE DUSA Efficacy Approval
03/06/2018 DEPAKOTE ER
NDA #021168		 SUPPL-38 DIVALPROEX SODIUM ABBVIE Labeling Approval
03/06/2018 SIMPONI
BLA #125289		 SUPPL-139 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
03/06/2018 MYTESI
NDA #202292		 SUPPL-6 CROFELEMER NAPO PHARMS INC Labeling Approval
03/06/2018 MEMANTINE HYDROCHLORIDE
ANDA #202790		 SUPPL-3 MEMANTINE HYDROCHLORIDE MACLEODS PHARMS LTD Manufacturing (CMC) Approval
03/06/2018 ARMODAFINIL
ANDA #206069		 ORIG-1 ARMODAFINIL AUROBINDO PHARMA LTD Approval
03/06/2018 FIASP
BLA #208751		 SUPPL-1 INSULIN ASPART NOVO Approval
03/06/2018 FIASP FLEXTOUCH
BLA #208751		 SUPPL-1 INSULIN ASPART NOVO Approval
03/06/2018 FIASP PENFILL
BLA #208751		 SUPPL-1 INSULIN ASPART NOVO Approval
03/06/2018 BACLOFEN
ANDA #209594		 ORIG-1 BACLOFEN MYLAN LABS LTD Approval
03/06/2018 STEGLUJAN
NDA #209805		 SUPPL-1 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
03/06/2018 TROGARZO
BLA #761065		 ORIG-1 IBALIZUMAB-UIYK THERATECHNOLOGIES Approval
03/07/2018 AQUAMEPHYTON
NDA #012223		 SUPPL-41 PHYTONADIONE PAI HOLDINGS PHARM Labeling Approval
03/07/2018 INTUNIV
NDA #022037		 SUPPL-16 GUANFACINE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
03/07/2018 ONDANSETRON
ANDA #076693		 SUPPL-2 ONDANSETRON BARR Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #076930		 SUPPL-8 ONDANSETRON HYDROCHLORIDE RISING PHARMA Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #076930		 SUPPL-9 ONDANSETRON HYDROCHLORIDE RISING PHARMA Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077112		 SUPPL-1 ONDANSETRON HYDROCHLORIDE PLIVA HRVATSKA DOO Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077112		 SUPPL-2 ONDANSETRON HYDROCHLORIDE PLIVA HRVATSKA DOO Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #078127		 SUPPL-10 ONDANSETRON HYDROCHLORIDE PHARM ASSOC Labeling Approval
03/07/2018 ONDANSETRON
ANDA #078139		 SUPPL-8 ONDANSETRON MYLAN Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #078539		 SUPPL-8 ONDANSETRON HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #078539		 SUPPL-9 ONDANSETRON HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #078776		 SUPPL-10 ONDANSETRON HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/07/2018 ONDANSETRON
ANDA #090469		 SUPPL-14 ONDANSETRON AUROBINDO PHARMA Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #091483		 SUPPL-5 ONDANSETRON HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
03/07/2018 ETOMIDATE
ANDA #201044		 SUPPL-1 ETOMIDATE MYLAN LABS LTD Labeling Approval
03/07/2018 ETOMIDATE
ANDA #202354		 SUPPL-2 ETOMIDATE HIKMA Labeling Approval
03/07/2018 ETOMIDATE
ANDA #202360		 SUPPL-2 ETOMIDATE ZYDUS PHARMS Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #203761		 SUPPL-2 ONDANSETRON HYDROCHLORIDE IPCA LABS LTD Labeling Approval
03/07/2018 ONDANSETRON HYDROCHLORIDE
ANDA #203761		 SUPPL-3 ONDANSETRON HYDROCHLORIDE IPCA LABS LTD Labeling Approval
03/07/2018 EPTIFIBATIDE
ANDA #204693		 ORIG-1 EPTIFIBATIDE SAGENT PHARMS INC Approval
03/07/2018 ETOMIDATE
ANDA #209058		 SUPPL-1 ETOMIDATE GLAND PHARMA LTD Labeling Approval
03/07/2018 ACYCLOVIR
ANDA #210401		 ORIG-1 ACYCLOVIR YILING Approval
03/08/2018 DIVALPROEX SODIUM
ANDA #077296		 SUPPL-4 DIVALPROEX SODIUM CHARTWELL RX Labeling Approval
03/08/2018 DIVALPROEX SODIUM
ANDA #077296		 SUPPL-5 DIVALPROEX SODIUM CHARTWELL RX Labeling Approval
03/08/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077517		 SUPPL-10 ONDANSETRON HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/08/2018 FOSPHENYTOIN SODIUM
ANDA #078765		 SUPPL-7 FOSPHENYTOIN SODIUM HIKMA FARMACEUTICA Labeling Approval
03/08/2018 FOSPHENYTOIN SODIUM
ANDA #078765		 SUPPL-8 FOSPHENYTOIN SODIUM HIKMA FARMACEUTICA Labeling Approval
03/08/2018 FOSPHENYTOIN SODIUM
ANDA #078765		 SUPPL-9 FOSPHENYTOIN SODIUM HIKMA FARMACEUTICA Labeling Approval
03/08/2018 NAFCILLIN SODIUM
ANDA #090002		 SUPPL-2 NAFCILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
03/08/2018 ETOMIDATE
ANDA #204618		 SUPPL-9 ETOMIDATE AVET LIFESCIENCES Labeling Approval
03/08/2018 CINACALCET HYDROCHLORIDE
ANDA #206125		 ORIG-1 CINACALCET HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
03/08/2018 ETOMIDATE
ANDA #206126		 SUPPL-1 ETOMIDATE EUGIA PHARMA Labeling Approval
03/08/2018 CINACALCET HYDROCHLORIDE
ANDA #208915		 ORIG-1 CINACALCET HYDROCHLORIDE CIPLA Approval
03/09/2018 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016677		 SUPPL-160 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/09/2018 DIFLUCAN
NDA #019949		 SUPPL-64 FLUCONAZOLE PFIZER Labeling Approval
03/09/2018 DIFLUCAN
NDA #020090		 SUPPL-46 FLUCONAZOLE PFIZER Labeling Approval
03/09/2018 EFFIENT
NDA #022307		 SUPPL-15 PRASUGREL HYDROCHLORIDE COSETTE Labeling Approval
03/09/2018 BRILINTA
NDA #022433		 SUPPL-22 TICAGRELOR ASTRAZENECA Labeling Approval
03/09/2018 OCTREOTIDE ACETATE
ANDA #077450		 SUPPL-6 OCTREOTIDE ACETATE FRESENIUS KABI USA Labeling Approval
03/09/2018 OCTREOTIDE ACETATE
ANDA #077450		 SUPPL-8 OCTREOTIDE ACETATE FRESENIUS KABI USA Labeling Approval
03/09/2018 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #077457		 SUPPL-6 OCTREOTIDE ACETATE FRESENIUS KABI USA Labeling Approval
03/09/2018 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #077457		 SUPPL-7 OCTREOTIDE ACETATE FRESENIUS KABI USA Labeling Approval
03/09/2018 SIGNIFOR
NDA #200677		 SUPPL-3 PASIREOTIDE DIASPARTATE RECORDATI RARE Labeling Approval
03/09/2018 RADIOGENIX SYSTEM
NDA #202158		 SUPPL-2 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR NORTHSTAR MEDICAL Labeling Approval
03/09/2018 SIGNIFOR LAR KIT
NDA #203255		 SUPPL-2 PASIREOTIDE PAMOATE RECORDATI RARE Labeling Approval
03/09/2018 MEKINIST
NDA #204114		 SUPPL-8 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Labeling Approval
03/09/2018 ACETIC ACID
ANDA #207280		 ORIG-1 ACETIC ACID, GLACIAL RISING PHARMA Approval
03/09/2018 TIZANIDINE HYDROCHLORIDE
ANDA #208187		 ORIG-1 TIZANIDINE HYDROCHLORIDE CADILA Approval
03/09/2018 ERYTHROMYCIN
ANDA #209720		 ORIG-1 ERYTHROMYCIN AMNEAL PHARMS CO Approval
03/12/2018 EFAVIRENZ
ANDA #204869		 ORIG-1 EFAVIRENZ STRIDES PHARMA Approval
03/13/2018 CANCIDAS
NDA #021227		 SUPPL-38 CASPOFUNGIN ACETATE MERCK Labeling Approval
03/13/2018 PRADAXA
NDA #022512		 SUPPL-35 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
03/13/2018 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #091281		 SUPPL-6 CYCLOBENZAPRINE HYDROCHLORIDE TWI PHARMS INC Bioequivalence Approval
03/13/2018 VIGABATRIN
ANDA #210155		 ORIG-1 VIGABATRIN AMNEAL PHARMS Approval
03/13/2018 TECENTRIQ
BLA #761034		 SUPPL-5 ATEZOLIZUMAB GENENTECH INC Approval
03/14/2018 DEXTROSE 20% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-69 DEXTROSE BAXTER HLTHCARE Labeling Approval
03/14/2018 DEXTROSE 30% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-69 DEXTROSE BAXTER HLTHCARE Labeling Approval
03/14/2018 DEXTROSE 40% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-69 DEXTROSE BAXTER HLTHCARE Labeling Approval
03/14/2018 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-69 DEXTROSE BAXTER HLTHCARE Labeling Approval
03/14/2018 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-69 DEXTROSE BAXTER HLTHCARE Labeling Approval
03/14/2018 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-69 DEXTROSE BAXTER HLTHCARE Labeling Approval
03/14/2018 RELISTOR
NDA #021964		 SUPPL-19 METHYLNALTREXONE BROMIDE SALIX PHARMS Labeling Approval
03/14/2018 AMLODIPINE BESYLATE
ANDA #076846		 SUPPL-16 AMLODIPINE BESYLATE TEVA Labeling Approval
03/14/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077050		 SUPPL-11 ONDANSETRON HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
03/14/2018 ONDANSETRON
ANDA #077557		 SUPPL-15 ONDANSETRON SUN PHARM INDS Labeling Approval
03/14/2018 ABACAVIR SULFATE
ANDA #077950		 ORIG-1 ABACAVIR SULFATE AUROBINDO PHARMA LTD Approval
03/14/2018 AMLODIPINE BESYLATE
ANDA #078021		 SUPPL-12 AMLODIPINE BESYLATE AUROBINDO PHARMA Labeling Approval
03/14/2018 AMLODIPINE BESYLATE
ANDA #078021		 SUPPL-13 AMLODIPINE BESYLATE AUROBINDO PHARMA Labeling Approval
03/14/2018 AMLODIPINE BESYLATE
ANDA #078226		 SUPPL-15 AMLODIPINE BESYLATE ZYDUS PHARMS USA Labeling Approval
03/14/2018 AMLODIPINE BESYLATE
ANDA #078226		 SUPPL-16 AMLODIPINE BESYLATE ZYDUS PHARMS USA Labeling Approval
03/14/2018 ONDANSETRON HYDROCHLORIDE
ANDA #091342		 SUPPL-5 ONDANSETRON HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
03/14/2018 ONDANSETRON HYDROCHLORIDE
ANDA #091342		 SUPPL-6 ONDANSETRON HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
03/14/2018 AMPICILLIN SODIUM
ANDA #201025		 SUPPL-1 AMPICILLIN SODIUM STERISCIENCE SPECLTS Labeling Approval
03/14/2018 AMPICILLIN SODIUM
ANDA #201025		 SUPPL-3 AMPICILLIN SODIUM STERISCIENCE SPECLTS Labeling Approval
03/14/2018 ROTIGOTINE
ANDA #206348		 ORIG-1 ROTIGOTINE ACTAVIS LABS UT INC Tentative Approval
03/14/2018 LEUCOVORIN CALCIUM
ANDA #207241		 ORIG-1 LEUCOVORIN CALCIUM FRESENIUS KABI USA Approval
03/14/2018 RELISTOR
NDA #208271		 SUPPL-3 METHYLNALTREXONE BROMIDE SALIX Labeling Approval
03/14/2018 DARUNAVIR
ANDA #210254		 ORIG-1 DARUNAVIR CIPLA LIMITED Tentative Approval
03/15/2018 METHOTREXATE SODIUM
NDA #008085		 SUPPL-68 METHOTREXATE SODIUM STRIDES PHARMA Labeling Approval
03/15/2018 METHOTREXATE LPF
NDA #011719		 SUPPL-126 METHOTREXATE SODIUM HOSPIRA Labeling Approval
03/15/2018 METHOTREXATE PRESERVATIVE FREE
NDA #011719		 SUPPL-126 METHOTREXATE SODIUM HOSPIRA Labeling Approval
03/15/2018 METHOTREXATE SODIUM
NDA #011719		 SUPPL-126 METHOTREXATE SODIUM HOSPIRA Labeling Approval
03/15/2018 METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719		 SUPPL-126 METHOTREXATE SODIUM HOSPIRA Labeling Approval
03/15/2018 INVIRASE
NDA #020628		 SUPPL-46 SAQUINAVIR MESYLATE HOFFMANN LA ROCHE Labeling Approval
03/15/2018 INVIRASE
NDA #021785		 SUPPL-22 SAQUINAVIR MESYLATE HOFFMANN-LA ROCHE Labeling Approval
03/15/2018 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-100 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
03/15/2018 CILOSTAZOL
ANDA #077708		 SUPPL-1 CILOSTAZOL NOSTRUM LABS INC Manufacturing (CMC) Approval
03/15/2018 CILOSTAZOL
ANDA #077708		 SUPPL-2 CILOSTAZOL NOSTRUM LABS INC Labeling Approval
03/15/2018 CILOSTAZOL
ANDA #077708		 SUPPL-3 CILOSTAZOL NOSTRUM LABS INC Labeling Approval
03/15/2018 OTREXUP
NDA #204824		 SUPPL-8 METHOTREXATE OTTER PHARMS Labeling Approval
03/15/2018 OTREXUP PFS
NDA #204824		 SUPPL-8 METHOTREXATE OTTER PHARMS Labeling Approval
03/15/2018 RASUVO
NDA #205776		 SUPPL-2 METHOTREXATE MEDEXUS Labeling Approval
03/15/2018 NAPROXEN SODIUM
ANDA #208363		 ORIG-1 NAPROXEN SODIUM PURACAP PHARM LLC Approval
03/15/2018 XATMEP
NDA #208400		 SUPPL-2 METHOTREXATE SODIUM AZURITY Labeling Approval
03/15/2018 ENTECAVIR
ANDA #208721		 ORIG-1 ENTECAVIR BRECKENRIDGE Approval
03/15/2018 AMJEVITA
BLA #761024		 SUPPL-3 ADALIMUMAB-ATTO AMGEN INC Approval
03/16/2018 ONDANSETRON
ANDA #076810		 SUPPL-5 ONDANSETRON TEVA Labeling Approval
03/16/2018 ONDANSETRON
ANDA #076810		 SUPPL-6 ONDANSETRON TEVA Labeling Approval
03/16/2018 CIMZIA
BLA #125160		 SUPPL-286 CERTOLIZUMAB PEGOL UCB INC Approval
03/16/2018 TALTZ
BLA #125521		 SUPPL-11 IXEKIZUMAB ELI LILLY AND CO Approval
03/16/2018 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #203345		 ORIG-1 OMEPRAZOLE; SODIUM BICARBONATE ZYDUS Approval
03/16/2018 MINOCYCLINE HYDROCHLORIDE
ANDA #204453		 ORIG-2 MINOCYCLINE HYDROCHLORIDE ALKEM LABS LTD Approval
03/16/2018 ROPIVACAINE HYDROCHLORIDE
ANDA #204636		 ORIG-1 ROPIVACAINE HYDROCHLORIDE RISING PHARMA Approval
03/16/2018 SODIUM POLYSTYRENE SULFONATE
ANDA #205727		 SUPPL-1 SODIUM POLYSTYRENE SULFONATE BELCHER Labeling Approval
03/16/2018 TETRABENAZINE
ANDA #206686		 SUPPL-1 TETRABENAZINE ACTAVIS LABS FL INC Labeling Approval
03/16/2018 DECITABINE
ANDA #207100		 ORIG-1 DECITABINE SAGENT PHARMS INC Approval
03/16/2018 CETYLEV
NDA #207916		 SUPPL-4 ACETYLCYSTEINE ARBOR PHARMS LLC Labeling Approval
03/16/2018 DESOXIMETASONE
ANDA #208124		 ORIG-1 DESOXIMETASONE LUPIN Approval
03/16/2018 METFORMIN HYDROCHLORIDE
ANDA #209313		 ORIG-1 METFORMIN HYDROCHLORIDE GRANULES Approval
03/19/2018 VIROPTIC
NDA #018299		 SUPPL-16 TRIFLURIDINE MONARCH PHARMS Manufacturing (CMC) Approval
03/19/2018 CYCLOPHOSPHAMIDE
ANDA #207014		 ORIG-1 CYCLOPHOSPHAMIDE ANI PHARMS Approval
03/19/2018 XHANCE
NDA #209022		 SUPPL-1 FLUTICASONE PROPIONATE OPTINOSE US INC Labeling Approval
03/19/2018 METFORMIN HYDROCHLORIDE
ANDA #209303		 ORIG-1 METFORMIN HYDROCHLORIDE ALIGNSCIENCE PHARMA Approval
03/19/2018 FENOFIBRATE
ANDA #209950		 ORIG-1 FENOFIBRATE AMNEAL Approval
03/20/2018 TEGRETOL
NDA #016608		 SUPPL-116 CARBAMAZEPINE NOVARTIS Labeling Approval
03/20/2018 LO/OVRAL-28
NDA #017802		 SUPPL-33 ETHINYL ESTRADIOL; NORGESTREL WYETH PHARMS Labeling Approval
03/20/2018 NORMINEST FE
NDA #017948		 SUPPL-45 ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE GD SEARLE LLC Labeling Approval
03/20/2018 TEGRETOL
NDA #018281		 SUPPL-58 CARBAMAZEPINE NOVARTIS Labeling Approval
03/20/2018 NORQUEST FE
NDA #018926		 SUPPL-12 ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE PFIZER Labeling Approval
03/20/2018 TEGRETOL
NDA #018927		 SUPPL-55 CARBAMAZEPINE NOVARTIS Labeling Approval
03/20/2018 TEGRETOL-XR
NDA #020234		 SUPPL-47 CARBAMAZEPINE NOVARTIS Labeling Approval
03/20/2018 AGRYLIN
NDA #020333		 SUPPL-24 ANAGRELIDE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
03/20/2018 ALESSE
NDA #020683		 SUPPL-12 ETHINYL ESTRADIOL; LEVONORGESTREL CADENCE HEALTH Labeling Approval
03/20/2018 LUCENTIS
BLA #125156		 SUPPL-117 RANIBIZUMAB GENENTECH Approval
03/20/2018 CIMZIA
BLA #125160		 SUPPL-281 CERTOLIZUMAB PEGOL UCB INC Approval
03/20/2018 ADCETRIS
BLA #125388		 SUPPL-97 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
03/20/2018 SEVELAMER CARBONATE
ANDA #200959		 ORIG-1 SEVELAMER CARBONATE ARTHUR GRP Approval
03/20/2018 POMALYST
NDA #204026		 SUPPL-17 POMALIDOMIDE BRISTOL Labeling Approval
03/20/2018 ORBACTIV
NDA #206334		 SUPPL-4 ORITAVANCIN DIPHOSPHATE MELINTA THERAP Labeling Approval
03/20/2018 LEVETIRACETAM
ANDA #209781		 ORIG-1 LEVETIRACETAM HAINAN POLY PHARM Approval
03/20/2018 HALOBETASOL PROPIONATE
ANDA #209978		 ORIG-1 HALOBETASOL PROPIONATE ENCUBE Approval
03/20/2018 ILUMYA
BLA #761067		 ORIG-1 TILDRAKIZUMAB-ASMN SUN PHARMA GLOBAL Approval
03/21/2018 KINEVAC
NDA #017697		 SUPPL-32 SINCALIDE BRACCO Labeling Approval
03/21/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #076655		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ACTAVIS LABS FL Approval
03/21/2018 OLOPATADINE HYDROCHLORIDE
ANDA #204392		 ORIG-1 OLOPATADINE HYDROCHLORIDE RISING PHARMA Approval
03/21/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #207510		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WES PHARMA INC Approval
03/21/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #208639		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APOTEX Approval
03/21/2018 BACLOFEN
ANDA #209592		 ORIG-1 BACLOFEN MYLAN LABS LTD Approval
03/22/2018 DDAVP
NDA #018938		 SUPPL-35 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
03/22/2018 TRILEPTAL
NDA #021014		 SUPPL-42 OXCARBAZEPINE NOVARTIS Labeling Approval
03/22/2018 TRILEPTAL
NDA #021285		 SUPPL-35 OXCARBAZEPINE NOVARTIS Labeling Approval
03/22/2018 TASIGNA
NDA #022068		 SUPPL-27 NILOTINIB HYDROCHLORIDE NOVARTIS Efficacy Approval
03/22/2018 SYMFI
NDA #022142		 ORIG-1 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN LABS LTD Type 4 - New Combination Approval
03/22/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #076772		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ACTAVIS LABS FL Approval
03/22/2018 ACTEMRA
BLA #125276		 SUPPL-116 TOCILIZUMAB GENENTECH Approval
03/22/2018 ACTEMRA
BLA #125472		 SUPPL-30 TOCILIZUMAB GENENTECH Approval
03/22/2018 ZYDELIG
NDA #205858		 SUPPL-12 IDELALISIB GILEAD SCIENCES INC REMS Approval
03/23/2018 DIFFERIN
NDA #020380		 SUPPL-13 ADAPALENE GALDERMA LABS LP Labeling Approval
03/23/2018 TORISEL
NDA #022088		 SUPPL-21 TEMSIROLIMUS PF PRISM CV Labeling Approval
03/23/2018 TORISEL
NDA #022088		 SUPPL-23 TEMSIROLIMUS PF PRISM CV Labeling Approval
03/23/2018 DULERA
NDA #022518		 SUPPL-23 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
03/23/2018 DULERA
NDA #022518		 SUPPL-24 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
03/23/2018 QSYMIA
NDA #022580		 SUPPL-16 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Labeling Approval
03/23/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #078458		 SUPPL-11 METHYLPHENIDATE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
03/23/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #078458		 SUPPL-12 METHYLPHENIDATE HYDROCHLORIDE DR REDDYS LABS SA Manufacturing (CMC) Approval
03/23/2018 IBUPROFEN
ANDA #079174		 SUPPL-17 IBUPROFEN GRANULES INDIA Labeling Approval
03/23/2018 AMPICILLIN SODIUM
ANDA #090354		 SUPPL-4 AMPICILLIN SODIUM ANTIBIOTICE Labeling Approval
03/23/2018 AMPICILLIN SODIUM
ANDA #090354		 SUPPL-5 AMPICILLIN SODIUM ANTIBIOTICE Labeling Approval
03/23/2018 PALONOSETRON HYDROCHLORIDE
ANDA #090713		 ORIG-1 PALONOSETRON HYDROCHLORIDE TEVA PHARMS USA Approval
03/23/2018 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202970		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Approval
03/23/2018 MESALAMINE
ANDA #203817		 ORIG-1 MESALAMINE ACTAVIS LABS FL Approval
03/23/2018 METOPROLOL SUCCINATE
ANDA #203894		 ORIG-1 METOPROLOL SUCCINATE ZYDUS PHARMS Approval
03/23/2018 OXACILLIN SODIUM
ANDA #207147		 SUPPL-1 OXACILLIN SODIUM WOCKHARDT BIO AG Manufacturing (CMC) Approval
03/26/2018 ASMANEX TWISTHALER
NDA #021067		 SUPPL-26 MOMETASONE FUROATE ORGANON LLC Labeling Approval
03/26/2018 ASMANEX TWISTHALER
NDA #021067		 SUPPL-28 MOMETASONE FUROATE ORGANON LLC Labeling Approval
03/26/2018 EMEND
NDA #022023		 SUPPL-18 FOSAPREPITANT DIMEGLUMINE MERCK AND CO INC Labeling Approval
03/26/2018 TRESIBA
BLA #203314		 SUPPL-8 INSULIN DEGLUDEC NOVO Approval
03/26/2018 ASMANEX HFA
NDA #205641		 SUPPL-7 MOMETASONE FUROATE ORGANON LLC Labeling Approval
03/26/2018 ASMANEX HFA
NDA #205641		 SUPPL-8 MOMETASONE FUROATE ORGANON LLC Labeling Approval
03/26/2018 CHOLINE C-11
ANDA #206319		 SUPPL-1 CHOLINE C-11 DECATUR Labeling Approval
03/26/2018 CHOLINE C-11
ANDA #206319		 SUPPL-5 CHOLINE C-11 DECATUR Manufacturing (CMC) Approval
03/26/2018 TOUJEO MAX SOLOSTAR
BLA #206538		 SUPPL-6 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
03/26/2018 TOUJEO SOLOSTAR
BLA #206538		 SUPPL-6 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
03/26/2018 DOFETILIDE
ANDA #207746		 ORIG-1 DOFETILIDE SIGMAPHARM LABS LLC Approval
03/26/2018 CLOBETASOL PROPIONATE
ANDA #208125		 ORIG-1 CLOBETASOL PROPIONATE LUPIN LTD Approval
03/26/2018 ENTERO VU 24%
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 LIQUID E-Z-PAQUE
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 READI-CAT 2
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 READI-CAT 2 SMOOTHIE
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 TAGITOL V
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 VARIBAR HONEY
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 VARIBAR NECTAR
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 VARIBAR THIN HONEY
NDA #208143		 SUPPL-7 BARIUM SULFATE BRACCO Efficacy Approval
03/26/2018 VORICONAZOLE
NDA #208562		 SUPPL-2 VORICONAZOLE XELLIA PHARMS APS Labeling Approval
03/26/2018 CLOBETASOL PROPIONATE
ANDA #208842		 ORIG-1 CLOBETASOL PROPIONATE TARO Approval
03/26/2018 CLOBETASOL PROPIONATE
ANDA #209004		 ORIG-1 CLOBETASOL PROPIONATE GLENMARK SPECLT Approval
03/26/2018 ZUMANDIMINE
ANDA #209407		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL AUROBINDO PHARMA LTD Approval
03/27/2018 HEPARIN LOCK FLUSH
NDA #017007		 SUPPL-39 HEPARIN SODIUM HIKMA Labeling Approval
03/27/2018 HEPARIN SODIUM
NDA #017007		 SUPPL-39 HEPARIN SODIUM HIKMA Labeling Approval
03/27/2018 ALEVE
NDA #020204		 SUPPL-53 NAPROXEN SODIUM BAYER Labeling Approval
03/27/2018 ZYPREXA
NDA #020592		 SUPPL-71 OLANZAPINE CHEPLAPHARM Labeling Approval
03/27/2018 ZYPREXA ZYDIS
NDA #021086		 SUPPL-46 OLANZAPINE CHEPLAPHARM Labeling Approval
03/27/2018 ZYPREXA
NDA #021253		 SUPPL-59 OLANZAPINE CHEPLAPHARM Labeling Approval
03/27/2018 SYMBYAX
NDA #021520		 SUPPL-50 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
03/27/2018 ZYPREXA RELPREVV
NDA #022173		 SUPPL-29 OLANZAPINE PAMOATE CHEPLAPHARM Labeling Approval
03/27/2018 DOXYCYCLINE HYCLATE
ANDA #090134		 SUPPL-18 DOXYCYCLINE HYCLATE ACTAVIS ELIZABETH Labeling Approval
03/28/2018 SOLU-MEDROL
NDA #011856		 SUPPL-131 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Labeling Approval
03/28/2018 DIPROLENE
NDA #018741		 SUPPL-38 BETAMETHASONE DIPROPIONATE ORGANON Labeling Approval
03/28/2018 DIPROLENE AF
NDA #019555		 SUPPL-34 BETAMETHASONE DIPROPIONATE ORGANON Labeling Approval
03/28/2018 DIPROLENE
NDA #019716		 SUPPL-32 BETAMETHASONE DIPROPIONATE ORGANON Labeling Approval
03/28/2018 TYZEKA
NDA #022011		 SUPPL-21 TELBIVUDINE NOVARTIS Labeling Approval
03/28/2018 TYZEKA
NDA #022154		 SUPPL-18 TELBIVUDINE NOVARTIS Labeling Approval
03/28/2018 IBUPROFEN
ANDA #204469		 ORIG-1 IBUPROFEN STRIDES PHARMA Approval
03/29/2018 KENALOG-10
NDA #012041		 SUPPL-44 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
03/29/2018 KENALOG-40
NDA #014901		 SUPPL-44 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
03/29/2018 KENALOG-80
NDA #014901		 SUPPL-44 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
03/29/2018 ALEVE
NDA #020204		 SUPPL-54 NAPROXEN SODIUM BAYER Labeling Approval
03/29/2018 LEUKINE
BLA #103362		 SUPPL-5240 SARGRAMOSTIM BERLEX LABS Approval
03/29/2018 BLINCYTO
BLA #125557		 SUPPL-13 BLINATUMOMAB AMGEN Approval
03/29/2018 TRIFERIC
NDA #206317		 SUPPL-10 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Labeling Approval
03/29/2018 TRIFERIC
NDA #208551		 SUPPL-5 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Labeling Approval
03/30/2018 SUPRAX
NDA #202091		 SUPPL-7 CEFIXIME LUPIN LTD Labeling Approval
03/30/2018 QNASL
NDA #202813		 SUPPL-12 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/30/2018 SUPRAX
NDA #203195		 SUPPL-8 CEFIXIME LUPIN LTD Labeling Approval
03/30/2018 CISATRACURIUM BESYLATE
ANDA #203236		 ORIG-1 CISATRACURIUM BESYLATE HOSPIRA Approval
03/30/2018 CISATRACURIUM BESYLATE
ANDA #203238		 ORIG-1 CISATRACURIUM BESYLATE HOSPIRA Approval
03/30/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #203863		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE EPIC PHARMA LLC Approval
03/30/2018 ATORVASTATIN CALCIUM
ANDA #207687		 ORIG-1 ATORVASTATIN CALCIUM ACCORD HLTHCARE Approval
03/30/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207808		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE RHODES PHARMS Approval
03/30/2018 METHADONE HYDROCHLORIDE
ANDA #208305		 ORIG-1 METHADONE HYDROCHLORIDE SUN PHARM INDUSTRIES Approval
03/30/2018 ESTRADIOL
ANDA #210488		 ORIG-1 ESTRADIOL TEVA PHARMS USA Approval
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