Drugs@FDA: FDA Approved Drug Products

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All Approvals
October 2019

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on October 22, 2019.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2019 VERELAN
NDA #019614		 SUPPL-56 VERAPAMIL HYDROCHLORIDE RECRO GAINESVILLE Labeling Approval
10/01/2019 MAXALT
NDA #020864		 SUPPL-23 RIZATRIPTAN BENZOATE MERCK Labeling Approval
10/01/2019 MAXALT-MLT
NDA #020865		 SUPPL-24 RIZATRIPTAN BENZOATE MERCK Labeling Approval
10/01/2019 CAPASTAT SULFATE
NDA #050095		 SUPPL-74 CAPREOMYCIN SULFATE AKORN Labeling Approval
10/01/2019 REPAGLINIDE
ANDA #077571		 SUPPL-8 REPAGLINIDE SUN PHARM INDS INC Labeling Approval
10/01/2019 REPAGLINIDE
ANDA #077571		 SUPPL-12 REPAGLINIDE SUN PHARM INDS INC Labeling Approval
10/01/2019 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-12 CLOPIDOGREL BISULFATE MYLAN PHARMS INC Labeling Approval
10/01/2019 TRANDOLAPRIL
ANDA #078438		 SUPPL-15 TRANDOLAPRIL AUROBINDO PHARMA Labeling Approval
10/01/2019 TRANDOLAPRIL
ANDA #078438		 SUPPL-16 TRANDOLAPRIL AUROBINDO PHARMA Labeling Approval
10/01/2019 MONTELUKAST SODIUM
ANDA #091414		 SUPPL-11 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
10/01/2019 PROLIA
BLA #125320		 SUPPL-202 DENOSUMAB AMGEN Approval
10/01/2019 XGEVA
BLA #125320		 SUPPL-202 DENOSUMAB AMGEN Approval
10/01/2019 MONTELUKAST SODIUM
ANDA #200889		 SUPPL-11 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
10/01/2019 BIVALIRUDIN
ANDA #201577		 SUPPL-2 BIVALIRUDIN DR REDDYS LABS LTD Labeling Approval
10/01/2019 CLOPIDOGREL BISULFATE
ANDA #201686		 SUPPL-2 CLOPIDOGREL BISULFATE CADILA Labeling Approval
10/01/2019 CLOPIDOGREL BISULFATE
ANDA #201686		 SUPPL-3 CLOPIDOGREL BISULFATE CADILA Labeling Approval
10/01/2019 CLOPIDOGREL BISULFATE
ANDA #201686		 SUPPL-4 CLOPIDOGREL BISULFATE CADILA Labeling Approval
10/01/2019 CLOPIDOGREL BISULFATE
ANDA #201686		 SUPPL-5 CLOPIDOGREL BISULFATE CADILA Labeling Approval
10/01/2019 CLOPIDOGREL BISULFATE
ANDA #201686		 SUPPL-6 CLOPIDOGREL BISULFATE CADILA Labeling Approval
10/01/2019 CELECOXIB
ANDA #204197		 SUPPL-7 CELECOXIB APOTEX INC Labeling Approval
10/01/2019 ENTRESTO
NDA #207620		 SUPPL-13 SACUBITRIL; VALSARTAN NOVARTIS PHARMS CORP Efficacy Approval
10/01/2019 NERLYNX
NDA #208051		 SUPPL-4 NERATINIB MALEATE PUMA BIOTECH Efficacy Approval
10/01/2019 AZITHROMYCIN
ANDA #208249		 SUPPL-1 AZITHROMYCIN CSPC OUYI Manufacturing (CMC) Approval
10/01/2019 CLOMIPRAMINE HYDROCHLORIDE
ANDA #208632		 SUPPL-1 CLOMIPRAMINE HYDROCHLORIDE AMNEAL PHARMS CO Labeling Approval
10/01/2019 CELECOXIB
ANDA #208833		 SUPPL-2 CELECOXIB AMNEAL PHARMS Labeling Approval
10/02/2019 ACARBOSE
ANDA #202271		 SUPPL-3 ACARBOSE EMCURE PHARMS LTD Labeling Approval
10/02/2019 LIDOCAINE
ANDA #202346		 SUPPL-12 LIDOCAINE MYLAN TECHNOLOGIES Labeling Approval
10/02/2019 SILDENAFIL CITRATE
ANDA #205791		 ORIG-1 SILDENAFIL CITRATE PERRIGO R AND D Tentative Approval
10/02/2019 METHADONE HYDROCHLORIDE
ANDA #207537		 ORIG-1 METHADONE HYDROCHLORIDE PHARM ASSOC Approval
10/02/2019 CLOBETASOL PROPIONATE
ANDA #211191		 ORIG-1 CLOBETASOL PROPIONATE ALEOR DERMACEUTICALS Approval
10/02/2019 CLOBETASOL PROPIONATE
ANDA #211494		 ORIG-1 CLOBETASOL PROPIONATE SAPTALIS PHARMS Approval
10/03/2019 VERELAN PM
NDA #020943		 SUPPL-35 VERAPAMIL HYDROCHLORIDE RECRO GAINESVILLE Labeling Approval
10/03/2019 FORTEO
NDA #021318		 SUPPL-52 TERIPARATIDE RECOMBINANT HUMAN LILLY Labeling Approval
10/03/2019 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-33 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
10/03/2019 CLARITIN
NDA #021891		 SUPPL-33 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
10/03/2019 FOSPHENYTOIN SODIUM
ANDA #078126		 SUPPL-11 FOSPHENYTOIN SODIUM APOTEX INC Labeling Approval
10/03/2019 FOSPHENYTOIN SODIUM
ANDA #078126		 SUPPL-12 FOSPHENYTOIN SODIUM APOTEX INC Labeling Approval
10/03/2019 DESLORATADINE
ANDA #078351		 SUPPL-4 DESLORATADINE MYLAN PHARMS INC Labeling Approval
10/03/2019 DESLORATADINE
ANDA #078351		 SUPPL-6 DESLORATADINE MYLAN PHARMS INC Labeling Approval
10/03/2019 ZALEPLON
ANDA #078989		 SUPPL-9 ZALEPLON UNICHEM Labeling Approval
10/03/2019 ZALEPLON
ANDA #078989		 SUPPL-10 ZALEPLON UNICHEM Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #079183		 SUPPL-7 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #079183		 SUPPL-8 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Labeling Approval
10/03/2019 TRIAMCINOLONE ACETONIDE
ANDA #090164		 SUPPL-9 TRIAMCINOLONE ACETONIDE SANDOZ INC Labeling Approval
10/03/2019 REPAGLINIDE
ANDA #090252		 SUPPL-5 REPAGLINIDE MYLAN Labeling Approval
10/03/2019 REPAGLINIDE
ANDA #090252		 SUPPL-9 REPAGLINIDE MYLAN Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #091365		 SUPPL-8 GEMCITABINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #091606		 SUPPL-7 LAMIVUDINE APOTEX Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #091606		 SUPPL-8 LAMIVUDINE APOTEX Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #091606		 SUPPL-9 LAMIVUDINE APOTEX Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #091606		 SUPPL-10 LAMIVUDINE APOTEX Labeling Approval
10/03/2019 NAPROXEN
ANDA #200429		 SUPPL-8 NAPROXEN AUROBINDO PHARMA LTD Labeling Approval
10/03/2019 NAPROXEN
ANDA #200429		 SUPPL-11 NAPROXEN AUROBINDO PHARMA LTD Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #202485		 SUPPL-4 GEMCITABINE HYDROCHLORIDE JIANGSU HANSOH PHARM Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #202485		 SUPPL-5 GEMCITABINE HYDROCHLORIDE JIANGSU HANSOH PHARM Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #202485		 SUPPL-8 GEMCITABINE HYDROCHLORIDE JIANGSU HANSOH PHARM Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #202485		 SUPPL-9 GEMCITABINE HYDROCHLORIDE JIANGSU HANSOH PHARM Labeling Approval
10/03/2019 DAPTOMYCIN
ANDA #202857		 SUPPL-12 DAPTOMYCIN HOSPIRA INC Labeling Approval
10/03/2019 DAPTOMYCIN
ANDA #202857		 SUPPL-16 DAPTOMYCIN HOSPIRA INC Labeling Approval
10/03/2019 TYBOST
NDA #203094		 SUPPL-14 COBICISTAT GILEAD SCIENCES INC Efficacy Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #204520		 SUPPL-3 GEMCITABINE HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #204520		 SUPPL-4 GEMCITABINE HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #204520		 SUPPL-6 GEMCITABINE HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #204528		 SUPPL-2 LAMIVUDINE MYLAN Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #204528		 SUPPL-3 LAMIVUDINE MYLAN Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #204528		 SUPPL-4 LAMIVUDINE MYLAN Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #204528		 SUPPL-6 LAMIVUDINE MYLAN Labeling Approval
10/03/2019 LAMIVUDINE
ANDA #204528		 SUPPL-7 LAMIVUDINE MYLAN Labeling Approval
10/03/2019 TRIAMCINOLONE ACETONIDE
ANDA #207550		 SUPPL-3 TRIAMCINOLONE ACETONIDE AMNEAL PHARMS CO Labeling Approval
10/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #207575		 SUPPL-1 GEMCITABINE HYDROCHLORIDE SHILPA MEDICARE LTD Labeling Approval
10/03/2019 DESCOVY
NDA #208215		 SUPPL-12 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
10/03/2019 HEMADY
NDA #211379		 ORIG-1 DEXAMETHASONE DEXCEL PHARMA Approval
10/03/2019 FASENRA
BLA #761070		 SUPPL-5 BENRALIZUMAB ASTRAZENECA AB Approval
10/04/2019 ZOCOR
NDA #019766		 SUPPL-100 SIMVASTATIN MSD MERCK CO Labeling Approval
10/04/2019 CYMBALTA
NDA #021427		 SUPPL-51 DULOXETINE HYDROCHLORIDE LILLY Labeling Approval
10/04/2019 VYTORIN
NDA #021687		 SUPPL-62 EZETIMIBE; SIMVASTATIN MSD INTL Labeling Approval
10/04/2019 MEPERIDINE HYDROCHLORIDE
ANDA #040110		 SUPPL-7 MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/04/2019 MEPERIDINE HYDROCHLORIDE
ANDA #088744		 SUPPL-28 MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/04/2019 TACROLIMUS
ANDA #090509		 SUPPL-16 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
10/04/2019 TACROLIMUS
ANDA #090509		 SUPPL-17 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
10/04/2019 TACROLIMUS
ANDA #090509		 SUPPL-19 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
10/04/2019 GUANFACINE HYDROCHLORIDE
ANDA #200881		 SUPPL-8 GUANFACINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/04/2019 GUANFACINE HYDROCHLORIDE
ANDA #200881		 SUPPL-9 GUANFACINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/04/2019 KYPROLIS
NDA #202714		 SUPPL-27 CARFILZOMIB ONYX THERAP Labeling Approval
10/04/2019 RAVICTI
NDA #203284		 SUPPL-11 GLYCEROL PHENYLBUTYRATE HORIZON THERAP Efficacy Approval
10/04/2019 ITRACONAZOLE
ANDA #204672		 SUPPL-1 ITRACONAZOLE ZYDUS PHARMS Labeling Approval
10/04/2019 ITRACONAZOLE
ANDA #204672		 SUPPL-2 ITRACONAZOLE ZYDUS PHARMS Labeling Approval
10/04/2019 ITRACONAZOLE
ANDA #204672		 SUPPL-3 ITRACONAZOLE ZYDUS PHARMS Labeling Approval
10/04/2019 RASAGILINE
ANDA #206153		 ORIG-1 RASAGILINE INDOCO REMEDIES Approval
10/04/2019 ITRACONAZOLE
ANDA #206741		 SUPPL-1 ITRACONAZOLE ALEMBIC PHARMS LTD Labeling Approval
10/04/2019 ITRACONAZOLE
ANDA #206741		 SUPPL-2 ITRACONAZOLE ALEMBIC PHARMS LTD Labeling Approval
10/04/2019 ITRACONAZOLE
ANDA #206741		 SUPPL-3 ITRACONAZOLE ALEMBIC PHARMS LTD Labeling Approval
10/04/2019 ITRACONAZOLE
ANDA #206741		 SUPPL-4 ITRACONAZOLE ALEMBIC PHARMS LTD Labeling Approval
10/04/2019 BORTEZOMIB
NDA #206927		 ORIG-1 BORTEZOMIB DR REDDYS LABS INC Type 5 - New Formulation or New Manufacturer Approval
10/04/2019 TRIPTODUR KIT
NDA #208956		 SUPPL-2 TRIPTORELIN PAMOATE ARBOR PHARMS LLC Labeling Approval
10/04/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #209385		 SUPPL-4 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ELITE LABS INC Labeling Approval
10/04/2019 GEMCITABINE HYDROCHLORIDE
ANDA #210991		 ORIG-1 GEMCITABINE HYDROCHLORIDE SHILPA MEDICARE LTD Approval
10/04/2019 QUZYTTIR
NDA #211415		 ORIG-1 CETIRIZINE HYDROCHLORIDE JDP THERAPEUTICS INC Type 3 - New Dosage Form Approval
10/04/2019 AKLIEF
NDA #211527		 ORIG-1 TRIFAROTENE GALDERMA RESEARCH AND DEVELOPMENT LLC Type 1 - New Molecular Entity Approval
10/04/2019 METHYLPHENIDATE HYDROCHLORIDE
ANDA #211779		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ALKEM LABS LTD Approval
10/04/2019 BONSITY
NDA #211939		 ORIG-1 TERIPARATIDE PFENEX INC Type 5 - New Formulation or New Manufacturer Approval
10/04/2019 DIGOXIN
ANDA #213000		 ORIG-1 DIGOXIN NOVITIUM PHARMA Approval
10/04/2019 AIMOVIG
BLA #761077		 SUPPL-3 ERENUMAB-AOOE AMGEN INC Approval
10/06/2019 TAFINLAR
NDA #202806		 SUPPL-12 DABRAFENIB MESYLATE NOVARTIS Efficacy Approval
10/06/2019 MEKINIST
NDA #204114		 SUPPL-12 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Efficacy Approval
10/07/2019 DEMEROL
NDA #005010		 SUPPL-58 MEPERIDINE HYDROCHLORIDE US PHARM HOLDINGS Labeling Approval
10/07/2019 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-49 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 PERCODAN
NDA #007337		 SUPPL-52 ASPIRIN; OXYCODONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
10/07/2019 PERCODAN
NDA #007337		 SUPPL-52 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ENDO PHARMS Labeling Approval
10/07/2019 PERCODAN-DEMI
NDA #007337		 SUPPL-52 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ENDO PHARMS Labeling Approval
10/07/2019 SYNALGOS-DC
NDA #011483		 SUPPL-33 ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE SUN PHARM INDUSTRIES Labeling Approval
10/07/2019 OPANA
NDA #011707		 SUPPL-37 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
10/07/2019 MEPERGAN
NDA #011730		 SUPPL-32 MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE HIKMA Labeling Approval
10/07/2019 TALWIN
NDA #016194		 SUPPL-81 PENTAZOCINE LACTATE HOSPIRA Labeling Approval
10/07/2019 SUBLIMAZE PRESERVATIVE FREE
NDA #016619		 SUPPL-43 FENTANYL CITRATE AKORN Labeling Approval
10/07/2019 METHADONE HYDROCHLORIDE
NDA #017058		 SUPPL-26 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 METHADOSE
NDA #017116		 SUPPL-38 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/07/2019 NUBAIN
NDA #018024		 SUPPL-42 NALBUPHINE HYDROCHLORIDE PAR PHARM INC Labeling Approval
10/07/2019 BUPRENEX
NDA #018401		 SUPPL-25 BUPRENORPHINE HYDROCHLORIDE INDIVIOR INC Labeling Approval
10/07/2019 DURAMORPH PF
NDA #018565		 SUPPL-24 MORPHINE SULFATE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 INFUMORPH
NDA #018565		 SUPPL-24 MORPHINE SULFATE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 DILAUDID
NDA #019034		 SUPPL-35 HYDROMORPHONE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/07/2019 DILAUDID-HP
NDA #019034		 SUPPL-35 HYDROMORPHONE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/07/2019 SUFENTA PRESERVATIVE FREE
NDA #019050		 SUPPL-37 SUFENTANIL CITRATE AKORN Labeling Approval
10/07/2019 FENTANYL CITRATE
NDA #019115		 SUPPL-33 FENTANYL CITRATE HOSPIRA Labeling Approval
10/07/2019 ALFENTA
NDA #019353		 SUPPL-23 ALFENTANIL HYDROCHLORIDE AKORN Labeling Approval
10/07/2019 FIORINAL W/CODEINE
NDA #019429		 SUPPL-43 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN SALES LLC Labeling Approval
10/07/2019 MS CONTIN
NDA #019516		 SUPPL-55 MORPHINE SULFATE PURDUE PHARMA LP Labeling Approval
10/07/2019 DURAGESIC-100
NDA #019813		 SUPPL-79 FENTANYL JANSSEN PHARMS Labeling Approval
10/07/2019 DURAGESIC-12
NDA #019813		 SUPPL-79 FENTANYL JANSSEN PHARMS Labeling Approval
10/07/2019 DURAGESIC-25
NDA #019813		 SUPPL-79 FENTANYL JANSSEN PHARMS Labeling Approval
10/07/2019 DURAGESIC-37
NDA #019813		 SUPPL-79 FENTANYL JANSSEN PHARMS Labeling Approval
10/07/2019 DURAGESIC-50
NDA #019813		 SUPPL-79 FENTANYL JANSSEN PHARMS Labeling Approval
10/07/2019 DURAGESIC-75
NDA #019813		 SUPPL-79 FENTANYL JANSSEN PHARMS Labeling Approval
10/07/2019 DILAUDID
NDA #019891		 SUPPL-28 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Labeling Approval
10/07/2019 DILAUDID
NDA #019892		 SUPPL-35 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #019916		 SUPPL-19 MORPHINE SULFATE ICU MEDICAL INC Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #019917		 SUPPL-12 MORPHINE SULFATE ICU MEDICAL INC Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #019999		 SUPPL-23 MORPHINE SULFATE MERIDIAN MEDCL TECHN Labeling Approval
10/07/2019 FIORICET W/ CODEINE
NDA #020232		 SUPPL-44 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ACTAVIS LABS UT INC Labeling Approval
10/07/2019 ULTRAM
NDA #020281		 SUPPL-45 TRAMADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
10/07/2019 KADIAN
NDA #020616		 SUPPL-63 MORPHINE SULFATE ALLERGAN SALES LLC Labeling Approval
10/07/2019 ULTIVA
NDA #020630		 SUPPL-20 REMIFENTANIL HYDROCHLORIDE MYLAN INSTITUTIONAL Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #020631		 SUPPL-2 MORPHINE SULFATE SPECGX LLC Labeling Approval
10/07/2019 SUBUTEX
NDA #020732		 SUPPL-22 BUPRENORPHINE HYDROCHLORIDE INDIVIOR INC Labeling Approval
10/07/2019 SUBOXONE
NDA #020733		 SUPPL-26 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC Labeling Approval
10/07/2019 ACTIQ
NDA #020747		 SUPPL-49 FENTANYL CITRATE CEPHALON Labeling Approval
10/07/2019 ROXICODONE
NDA #021011		 SUPPL-10 OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/07/2019 ULTRACET
NDA #021123		 SUPPL-19 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
10/07/2019 DEMEROL
NDA #021171		 SUPPL-32 MEPERIDINE HYDROCHLORIDE HOSPIRA Labeling Approval
10/07/2019 EXALGO
NDA #021217		 SUPPL-25 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/07/2019 BUTRANS
NDA #021306		 SUPPL-35 BUPRENORPHINE PURDUE PHARMA LP Labeling Approval
10/07/2019 OPANA ER
NDA #021610		 SUPPL-27 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
10/07/2019 OPANA
NDA #021611		 SUPPL-17 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
10/07/2019 METHADONE HYDROCHLORIDE
NDA #021624		 SUPPL-10 METHADONE HYDROCHLORIDE MYLAN INSTITUTIONAL Labeling Approval
10/07/2019 FENTORA
NDA #021947		 SUPPL-29 FENTANYL CITRATE CEPHALON Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #022195		 SUPPL-18 MORPHINE SULFATE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #022207		 SUPPL-9 MORPHINE SULFATE HIKMA Labeling Approval
10/07/2019 ONSOLIS
NDA #022266		 SUPPL-23 FENTANYL CITRATE BDSI Labeling Approval
10/07/2019 OXYCONTIN
NDA #022272		 SUPPL-43 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Labeling Approval
10/07/2019 NUCYNTA
NDA #022304		 SUPPL-22 TAPENTADOL HYDROCHLORIDE DEPO NF Labeling Approval
10/07/2019 EMBEDA
NDA #022321		 SUPPL-30 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS Labeling Approval
10/07/2019 CONZIP
NDA #022370		 SUPPL-18 TRAMADOL HYDROCHLORIDE CIPHER PHARMS INC Labeling Approval
10/07/2019 CODEINE SULFATE
NDA #022402		 SUPPL-12 CODEINE SULFATE HIKMA Labeling Approval
10/07/2019 SUBOXONE
NDA #022410		 SUPPL-38 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC Labeling Approval
10/07/2019 ABSTRAL
NDA #022510		 SUPPL-18 FENTANYL CITRATE SENTYNL THERAPS INC Labeling Approval
10/07/2019 LAZANDA
NDA #022569		 SUPPL-27 FENTANYL CITRATE BTCP PHARMA Labeling Approval
10/07/2019 NORCO
ANDA #040099		 SUPPL-23 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040119		 SUPPL-15 ACETAMINOPHEN; CODEINE PHOSPHATE HI TECH PHARMA Labeling Approval
10/07/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040148		 SUPPL-73 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
10/07/2019 NORCO
ANDA #040148		 SUPPL-73 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
10/07/2019 PERCOCET
ANDA #040330		 SUPPL-55 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE VINTAGE PHARMS LLC Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040419		 SUPPL-26 ACETAMINOPHEN; CODEINE PHOSPHATE SPECGX LLC Labeling Approval
10/07/2019 METAXALONE
ANDA #040486		 SUPPL-7 METAXALONE MOUNTAIN Labeling Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040777		 SUPPL-17 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040778		 SUPPL-19 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMNEAL PHARMS NY Labeling Approval
10/07/2019 CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
ANDA #040860		 SUPPL-5 ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE INGENUS PHARMS NJ Labeling Approval
10/07/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040894		 SUPPL-12 ACETAMINOPHEN; HYDROCODONE BITARTRATE GENUS LIFESCIENCES Labeling Approval
10/07/2019 BUTORPHANOL TARTRATE
ANDA #075824		 SUPPL-13 BUTORPHANOL TARTRATE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078316		 SUPPL-11 IBUPROFEN; OXYCODONE HYDROCHLORIDE BARR LABS INC Labeling Approval
10/07/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-18 BUPRENORPHINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #081249		 SUPPL-12 ACETAMINOPHEN; CODEINE PHOSPHATE FOSUN PHARMA Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #081250		 SUPPL-12 ACETAMINOPHEN; CODEINE PHOSPHATE FOSUN PHARMA Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085861		 SUPPL-78 ACETAMINOPHEN; CODEINE PHOSPHATE ACTAVIS MID ATLANTIC Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085868		 SUPPL-65 ACETAMINOPHEN; CODEINE PHOSPHATE SUN PHARM INDS LTD Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087006		 SUPPL-36 ACETAMINOPHEN; CODEINE PHOSPHATE WOCKHARDT BIO AG Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087083		 SUPPL-52 ACETAMINOPHEN; CODEINE PHOSPHATE SUN PHARM INDS LTD Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087508		 SUPPL-47 ACETAMINOPHEN; CODEINE PHOSPHATE PHARM ASSOC Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089450		 SUPPL-26 ACETAMINOPHEN; CODEINE PHOSPHATE ANDA REPOSITORY Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089673		 SUPPL-28 ACETAMINOPHEN; CODEINE PHOSPHATE RHODES PHARMS Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089805		 SUPPL-35 ACETAMINOPHEN; CODEINE PHOSPHATE VINTAGE Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089805		 SUPPL-36 ACETAMINOPHEN; CODEINE PHOSPHATE VINTAGE Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089828		 SUPPL-32 ACETAMINOPHEN; CODEINE PHOSPHATE VINTAGE PHARMS Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089828		 SUPPL-33 ACETAMINOPHEN; CODEINE PHOSPHATE VINTAGE PHARMS Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089990		 SUPPL-30 ACETAMINOPHEN; CODEINE PHOSPHATE VINTAGE Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089990		 SUPPL-31 ACETAMINOPHEN; CODEINE PHOSPHATE VINTAGE Labeling Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #090733		 SUPPL-18 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE VINTAGE PHARMS Labeling Approval
10/07/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149		 SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #091238		 SUPPL-17 ACETAMINOPHEN; CODEINE PHOSPHATE LANNETT CO INC Labeling Approval
10/07/2019 HYDROMORPHONE HYDROCHLORIDE
NDA #200403		 SUPPL-18 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Labeling Approval
10/07/2019 NUCYNTA ER
NDA #200533		 SUPPL-20 TAPENTADOL HYDROCHLORIDE DEPO NF Labeling Approval
10/07/2019 OXYCODONE HYDROCHLORIDE
NDA #200534		 SUPPL-9 OXYCODONE HYDROCHLORIDE GENUS LIFESCIENCES Labeling Approval
10/07/2019 OXYCODONE HYDROCHLORIDE
NDA #200535		 SUPPL-16 OXYCODONE HYDROCHLORIDE GENUS LIFESCIENCES Labeling Approval
10/07/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #201066		 SUPPL-11 BUPRENORPHINE HYDROCHLORIDE MYLAN Labeling Approval
10/07/2019 OXYCODONE HYDROCHLORIDE
NDA #201194		 SUPPL-8 OXYCODONE HYDROCHLORIDE VISTAPHARM Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #201517		 SUPPL-15 MORPHINE SULFATE LANNETT CO INC Labeling Approval
10/07/2019 OPANA ER
NDA #201655		 SUPPL-26 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #201972		 SUPPL-13 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
10/07/2019 OXAYDO
NDA #202080		 SUPPL-11 OXYCODONE HYDROCHLORIDE ZYLA Labeling Approval
10/07/2019 CODEINE SULFATE
NDA #202245		 SUPPL-8 CODEINE SULFATE HIKMA Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #202515		 SUPPL-17 MORPHINE SULFATE HOSPIRA INC Labeling Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #202677		 SUPPL-14 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ALVOGEN Labeling Approval
10/07/2019 SUBSYS
NDA #202788		 SUPPL-20 FENTANYL BTCP PHARMA Labeling Approval
10/07/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #202800		 SUPPL-12 ACETAMINOPHEN; CODEINE PHOSPHATE AUROLIFE PHARMA LLC Labeling Approval
10/07/2019 ZOHYDRO ER
NDA #202880		 SUPPL-19 HYDROCODONE BITARTRATE PERSION Labeling Approval
10/07/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203326		 SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/07/2019 NUCYNTA
NDA #203794		 SUPPL-8 TAPENTADOL HYDROCHLORIDE ASSERTIO Labeling Approval
10/07/2019 FETZIMA
NDA #204168		 SUPPL-6 LEVOMILNACIPRAN HYDROCHLORIDE ALLERGAN SALES LLC Efficacy Approval
10/07/2019 ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
ANDA #204209		 SUPPL-10 ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE LARKEN LABS INC Labeling Approval
10/07/2019 MORPHINE SULFATE
NDA #204223		 SUPPL-15 MORPHINE SULFATE FRESENIUS KABI USA Labeling Approval
10/07/2019 ZUBSOLV
NDA #204242		 SUPPL-17 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE OREXO US INC Labeling Approval
10/07/2019 PROBUPHINE
NDA #204442		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE TITAN PHARMS Labeling Approval
10/07/2019 BUNAVAIL
NDA #205637		 SUPPL-20 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BDSI Labeling Approval
10/07/2019 HETLIOZ
NDA #205677		 SUPPL-6 TASIMELTEON VANDA PHARMS INC Labeling Approval
10/07/2019 PIROXICAM
ANDA #206152		 SUPPL-1 PIROXICAM MICRO LABS Labeling Approval
10/07/2019 MORPHABOND ER
NDA #206544		 SUPPL-12 MORPHINE SULFATE DAIICHI SANKYO INC Labeling Approval
10/07/2019 HYSINGLA ER
NDA #206627		 SUPPL-10 HYDROCODONE BITARTRATE PURDUE PHARMA LP Labeling Approval
10/07/2019 LAMIVUDINE
ANDA #206974		 SUPPL-5 LAMIVUDINE ARISE Labeling Approval
10/07/2019 LAMIVUDINE
ANDA #206974		 SUPPL-6 LAMIVUDINE ARISE Labeling Approval
10/07/2019 TADALAFIL
ANDA #207244		 ORIG-1 TADALAFIL MACLEODS PHARMS LTD Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #207419		 SUPPL-6 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ASCENT PHARMS INC Labeling Approval
10/07/2019 COLESEVELAM HYDROCHLORIDE
ANDA #207765		 ORIG-1 COLESEVELAM HYDROCHLORIDE ZYDUS PHARMS Approval
10/07/2019 BELBUCA
NDA #207932		 SUPPL-12 BUPRENORPHINE HYDROCHLORIDE BDSI Labeling Approval
10/07/2019 CASSIPA
NDA #208042		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
10/07/2019 XTAMPZA ER
NDA #208090		 SUPPL-12 OXYCODONE COLLEGIUM PHARM INC Labeling Approval
10/07/2019 ARYMO ER
NDA #208603		 SUPPL-5 MORPHINE SULFATE ZYLA Labeling Approval
10/07/2019 APADAZ
NDA #208653		 SUPPL-5 ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE KVK TECH INC Labeling Approval
10/07/2019 DSUVIA
NDA #209128		 SUPPL-3 SUFENTANIL CITRATE ACELRX PHARMS Labeling Approval
10/07/2019 ACYCLOVIR
ANDA #209366		 ORIG-1 ACYCLOVIR SQUARE PHARMS LTD Approval
10/07/2019 DOXYCYCLINE HYCLATE
ANDA #209402		 ORIG-1 DOXYCYCLINE HYCLATE CHANGZHOU PHARM Approval
10/07/2019 ROXYBOND
NDA #209777		 SUPPL-6 OXYCODONE HYDROCHLORIDE INSPIRION DELIVERY Labeling Approval
10/07/2019 SUBLOCADE
NDA #209819		 SUPPL-9 BUPRENORPHINE INDIVIOR INC Labeling Approval
10/07/2019 DIMETHYL FUMARATE
ANDA #210309		 ORIG-1 DIMETHYL FUMARATE GLENMARK PHARMS Tentative Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #210644		 SUPPL-3 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ABHAI LLC Labeling Approval
10/07/2019 SUNOSI
NDA #211230		 SUPPL-1 SOLRIAMFETOL JAZZ Labeling Approval
10/07/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #211499		 SUPPL-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ABHAI LLC Labeling Approval
10/07/2019 BEOVU
BLA #761125		 ORIG-1 brolucizumab-dbll NOVARTIS PHARMS CORP Approval
10/08/2019 FENTANYL CITRATE PRESERVATIVE FREE
NDA #019101		 SUPPL-51 FENTANYL CITRATE WEST-WARD PHARMS INT Labeling Approval
10/08/2019 HYCAMTIN
NDA #020671		 SUPPL-24 TOPOTECAN HYDROCHLORIDE NOVARTIS Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040105		 SUPPL-34 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE VINTAGE PHARMS Labeling Approval
10/08/2019 MEPERIDINE HYDROCHLORIDE
ANDA #040110		 SUPPL-8 MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040171		 SUPPL-35 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WATSON LABS Labeling Approval
10/08/2019 OXYCODONE AND ASPIRIN
ANDA #040255		 SUPPL-29 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ANI PHARMS INC Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040535		 SUPPL-34 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WATSON LABS Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040608		 SUPPL-16 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MIKART Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040680		 SUPPL-13 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/08/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040779		 SUPPL-21 ACETAMINOPHEN; CODEINE PHOSPHATE AMNEAL PHARMS NY Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040800		 SUPPL-7 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/08/2019 BUTORPHANOL TARTRATE
ANDA #075759		 SUPPL-31 BUTORPHANOL TARTRATE MYLAN Labeling Approval
10/08/2019 MOMETASONE FUROATE
ANDA #077180		 SUPPL-9 MOMETASONE FUROATE PERRIGO ISRAEL Labeling Approval
10/08/2019 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078769		 SUPPL-25 IBUPROFEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/08/2019 PERCOCET
ANDA #085106		 SUPPL-29 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE VINTAGE PHARMS LLC Labeling Approval
10/08/2019 ROXICET
ANDA #087003		 SUPPL-43 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/08/2019 MEPERIDINE HYDROCHLORIDE
ANDA #088744		 SUPPL-29 MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/08/2019 ROXICET
ANDA #089351		 SUPPL-31 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/08/2019 OXYCODONE AND ASPIRIN
ANDA #090084		 SUPPL-8 ASPIRIN; OXYCODONE HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #090177		 SUPPL-17 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
10/08/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360		 SUPPL-17 BUPRENORPHINE HYDROCHLORIDE BARR Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #090734		 SUPPL-24 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE VINTAGE PHARMS Labeling Approval
10/08/2019 OXYCODONE AND ASPIRIN
ANDA #091670		 SUPPL-5 ASPIRIN; OXYCODONE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #201278		 SUPPL-10 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE RHODES PHARMS Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #201447		 SUPPL-16 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #202142		 SUPPL-2 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MIKART INC Labeling Approval
10/08/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 SUPPL-21 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
10/08/2019 OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #203573		 SUPPL-8 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE VINTAGE PHARMS Labeling Approval
10/08/2019 OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #203573		 SUPPL-9 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE VINTAGE PHARMS Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #203864		 SUPPL-4 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #204407		 SUPPL-4 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE NOVEL LABS INC Labeling Approval
10/08/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE LANNETT CO INC Labeling Approval
10/08/2019 PREGABALIN
ANDA #206912		 ORIG-1 PREGABALIN HETERO LABS LTD III Approval
10/08/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #207333		 SUPPL-6 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE LANNETT CO INC Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #207574		 SUPPL-7 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE XIROMED Labeling Approval
10/08/2019 OLUMIANT
NDA #207924		 SUPPL-1 BARICITINIB ELI LILLY AND CO Efficacy Approval
10/08/2019 BENDEKA
NDA #208194		 SUPPL-19 BENDAMUSTINE HYDROCHLORIDE EAGLE PHARMS Labeling Approval
10/08/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #209385		 SUPPL-6 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ELITE LABS INC Labeling Approval
10/08/2019 SCENESSE
NDA #210797		 ORIG-1 AFAMELANOTIDE CLINUVEL INC Type 1 - New Molecular Entity Approval
10/09/2019 LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016679		 SUPPL-114 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #016682		 SUPPL-117 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 HALCION
NDA #017892		 SUPPL-50 TRIAZOLAM PHARMACIA AND UPJOHN Labeling Approval
10/09/2019 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
10/09/2019 ADDYI
NDA #022526		 SUPPL-8 FLIBANSERIN SPROUT PHARMS Labeling Approval
10/09/2019 ADDYI
NDA #022526		 SUPPL-9 FLIBANSERIN SPROUT PHARMS REMS Approval
10/09/2019 OXYCODONE AND ASPIRIN
ANDA #040260		 SUPPL-17 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE SUN PHARM INDUSTRIES Labeling Approval
10/09/2019 NALBUPHINE HYDROCHLORIDE
ANDA #074471		 SUPPL-4 NALBUPHINE HYDROCHLORIDE DR REDDYS Labeling Approval
10/09/2019 BUTORPHANOL TARTRATE
ANDA #075499		 SUPPL-26 BUTORPHANOL TARTRATE APOTEX INC Labeling Approval
10/09/2019 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
ANDA #075523		 SUPPL-5 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
10/09/2019 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
ANDA #075735		 SUPPL-15 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE LUPIN Labeling Approval
10/09/2019 HALOPERIDOL
ANDA #075858		 SUPPL-22 HALOPERIDOL LACTATE WEST-WARD PHARMS INT Labeling Approval
10/09/2019 ITRACONAZOLE
ANDA #076104		 SUPPL-19 ITRACONAZOLE SANDOZ Labeling Approval
10/09/2019 ITRACONAZOLE
ANDA #076104		 SUPPL-20 ITRACONAZOLE SANDOZ Labeling Approval
10/09/2019 ITRACONAZOLE
ANDA #076104		 SUPPL-21 ITRACONAZOLE SANDOZ Labeling Approval
10/09/2019 ITRACONAZOLE
ANDA #076104		 SUPPL-22 ITRACONAZOLE SANDOZ Labeling Approval
10/09/2019 HALOPERIDOL
ANDA #078347		 SUPPL-13 HALOPERIDOL LACTATE MYLAN LABS LTD Labeling Approval
10/09/2019 TRAMADOL HYDROCHLORIDE
ANDA #078783		 SUPPL-10 TRAMADOL HYDROCHLORIDE PAR PHARM INC Labeling Approval
10/09/2019 CELECOXIB
ANDA #078857		 SUPPL-7 CELECOXIB MYLAN Labeling Approval
10/09/2019 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-48 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/09/2019 OXYCODONE AND ASPIRIN
ANDA #087794		 SUPPL-29 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE SUN PHARM INDUSTRIES Labeling Approval
10/09/2019 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-40 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/09/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088627		 SUPPL-62 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Labeling Approval
10/09/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088628		 SUPPL-71 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Labeling Approval
10/09/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629		 SUPPL-70 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Labeling Approval
10/09/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089997		 SUPPL-23 ACETAMINOPHEN; CODEINE PHOSPHATE WATSON LABS Labeling Approval
10/09/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089998		 SUPPL-23 ACETAMINOPHEN; CODEINE PHOSPHATE WATSON LABS Labeling Approval
10/09/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089999		 SUPPL-22 ACETAMINOPHEN; CODEINE PHOSPHATE WATSON LABS Labeling Approval
10/09/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #090279		 SUPPL-10 BUPRENORPHINE HYDROCHLORIDE CASI PHARMS INC Labeling Approval
10/09/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #090535		 SUPPL-14 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
10/09/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622		 SUPPL-30 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM Labeling Approval
10/09/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #090819		 SUPPL-16 BUPRENORPHINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/09/2019 ANASTROZOLE
ANDA #091164		 SUPPL-2 ANASTROZOLE CIPLA Labeling Approval
10/09/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422		 SUPPL-29 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/09/2019 GRANIX
BLA #125294		 SUPPL-48 TBO-FILGRASTIM SICOR BIOTECH Approval
10/09/2019 TRAMADOL HYDROCHLORIDE
ANDA #200503		 SUPPL-9 TRAMADOL HYDROCHLORIDE LUPIN LTD Labeling Approval
10/09/2019 CELECOXIB
ANDA #200562		 SUPPL-4 CELECOXIB WATSON LABS INC Labeling Approval
10/09/2019 CELECOXIB
ANDA #200562		 SUPPL-5 CELECOXIB WATSON LABS INC Labeling Approval
10/09/2019 OXYMORPHONE HYDROCHLORIDE
ANDA #200822		 SUPPL-14 OXYMORPHONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/09/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUN PHARM Labeling Approval
10/09/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #201760		 SUPPL-12 BUPRENORPHINE HYDROCHLORIDE SUN PHARM Labeling Approval
10/09/2019 CELECOXIB
ANDA #202240		 SUPPL-4 CELECOXIB LUPIN LTD Labeling Approval
10/09/2019 CELECOXIB
ANDA #202240		 SUPPL-7 CELECOXIB LUPIN LTD Manufacturing (CMC) Approval
10/09/2019 CELECOXIB
ANDA #202240		 SUPPL-8 CELECOXIB LUPIN LTD Labeling Approval
10/09/2019 DECITABINE
ANDA #203131		 SUPPL-6 DECITABINE DR REDDYS Labeling Approval
10/09/2019 BOSULIF
NDA #203341		 SUPPL-17 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
10/09/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431		 SUPPL-17 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ETHYPHARM USA CORP Labeling Approval
10/09/2019 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #207310		 SUPPL-5 SODIUM CHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
10/09/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #207510		 SUPPL-3 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WES PHARMA INC Labeling Approval
10/09/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #207510		 SUPPL-4 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WES PHARMA INC Labeling Approval
10/09/2019 CAPECITABINE
ANDA #207652		 SUPPL-3 CAPECITABINE ALKEM LABS LTD Labeling Approval
10/09/2019 DAUNORUBICIN HYDROCHLORIDE
ANDA #208759		 SUPPL-1 DAUNORUBICIN HYDROCHLORIDE HISUN PHARM HANGZHOU Manufacturing (CMC) Approval
10/09/2019 PEMFEXY
NDA #209472		 ORIG-1 PEMETREXED EAGLE PHARMS Type 5 - New Formulation or New Manufacturer Tentative Approval
10/09/2019 DOXYCYCLINE HYCLATE
ANDA #211343		 ORIG-1 DOXYCYCLINE HYCLATE CHANGZHOU PHARM Approval
10/09/2019 SUCCINYLCHOLINE CHLORIDE
ANDA #212638		 ORIG-1 SUCCINYLCHOLINE CHLORIDE GPP Approval
10/10/2019 ENTEREG
NDA #021775		 SUPPL-16 ALVIMOPAN CUBIST PHARMS Labeling Approval
10/10/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040736		 SUPPL-21 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Labeling Approval
10/10/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040746		 SUPPL-23 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Labeling Approval
10/10/2019 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
ANDA #074736		 SUPPL-35 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE WATSON LABS Labeling Approval
10/10/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-28 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
10/10/2019 REPREXAIN
ANDA #076642		 SUPPL-28 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
10/10/2019 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-30 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/10/2019 FLUORODOPA F 18
NDA #200655		 ORIG-1 FLUORODOPA F 18 FEINSTEIN Type 1 - New Molecular Entity Approval
10/10/2019 ASENAPINE MALEATE
ANDA #206107		 ORIG-1 ASENAPINE MALEATE SIGMAPHARM LABS LLC Tentative Approval
10/10/2019 NALBUPHINE HYDROCHLORIDE
ANDA #206506		 SUPPL-1 NALBUPHINE HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
10/10/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206869		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Labeling Approval
10/10/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207137		 SUPPL-4 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS Labeling Approval
10/10/2019 CAPECITABINE
ANDA #207456		 SUPPL-1 CAPECITABINE SHILPA MEDICARE LTD Labeling Approval
10/10/2019 CAPECITABINE
ANDA #207456		 SUPPL-2 CAPECITABINE SHILPA MEDICARE LTD Labeling Approval
10/10/2019 NALBUPHINE HYDROCHLORIDE
ANDA #207595		 SUPPL-1 NALBUPHINE HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
10/10/2019 DOXYCYCLINE HYCLATE
ANDA #209372		 SUPPL-1 DOXYCYCLINE HYCLATE AMNEAL PHARMS CO Labeling Approval
10/10/2019 CASPOFUNGIN ACETATE
ANDA #209489		 SUPPL-1 CASPOFUNGIN ACETATE CIPLA Labeling Approval
10/10/2019 PIFELTRO
NDA #210806		 SUPPL-3 DORAVIRINE MSD MERCK CO Efficacy Approval
10/10/2019 DELSTRIGO
NDA #210807		 SUPPL-3 DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MSD MERCK CO Efficacy Approval
10/11/2019 FERAHEME
NDA #022180		 SUPPL-23 FERUMOXYTOL AMAG PHARMS INC Labeling Approval
10/11/2019 DOCETAXEL
NDA #022234		 SUPPL-12 DOCETAXEL HOSPIRA INC Labeling Approval
10/11/2019 DOCETAXEL
NDA #022234		 SUPPL-13 DOCETAXEL HOSPIRA INC Labeling Approval
10/11/2019 DOCETAXEL
NDA #022234		 SUPPL-15 DOCETAXEL HOSPIRA INC Labeling Approval
10/11/2019 XARELTO
NDA #022406		 SUPPL-33 RIVAROXABAN JANSSEN PHARMS Efficacy Approval
10/11/2019 MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #040163		 SUPPL-4 MEPERIDINE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/11/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040203		 SUPPL-11 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040248		 SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE WATSON LABS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040355		 SUPPL-39 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040355		 SUPPL-41 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040400		 SUPPL-30 ACETAMINOPHEN; HYDROCODONE BITARTRATE SPECGX LLC Labeling Approval
10/11/2019 ANEXSIA 7.5/325
ANDA #040405		 SUPPL-30 ACETAMINOPHEN; HYDROCODONE BITARTRATE SPECGX LLC Labeling Approval
10/11/2019 ANEXSIA 5/325
ANDA #040409		 SUPPL-30 ACETAMINOPHEN; HYDROCODONE BITARTRATE SPECGX LLC Labeling Approval
10/11/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #040545		 SUPPL-17 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040655		 SUPPL-29 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040655		 SUPPL-31 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040656		 SUPPL-29 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040656		 SUPPL-31 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040658		 SUPPL-15 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040826		 SUPPL-11 ACETAMINOPHEN; HYDROCODONE BITARTRATE SUN PHARM INDS LTD Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040834		 SUPPL-17 ACETAMINOPHEN; HYDROCODONE BITARTRATE PHARM ASSOC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040838		 SUPPL-15 ACETAMINOPHEN; HYDROCODONE BITARTRATE PHARM ASSOC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040881		 SUPPL-12 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
10/11/2019 LEVORPHANOL TARTRATE
ANDA #074278		 SUPPL-14 LEVORPHANOL TARTRATE SENTYNL THERAPS INC Labeling Approval
10/11/2019 BUTORPHANOL TARTRATE PRESERVATIVE FREE
ANDA #074626		 SUPPL-30 BUTORPHANOL TARTRATE HOSPIRA Labeling Approval
10/11/2019 BUTORPHANOL TARTRATE PRESERVATIVE FREE
ANDA #075045		 SUPPL-15 BUTORPHANOL TARTRATE WEST-WARD PHARMS INT Labeling Approval
10/11/2019 BUTORPHANOL TARTRATE
ANDA #075046		 SUPPL-13 BUTORPHANOL TARTRATE WEST-WARD PHARMS INT Labeling Approval
10/11/2019 BUTORPHANOL TARTRATE PRESERVATIVE FREE
ANDA #075695		 SUPPL-23 BUTORPHANOL TARTRATE BAXTER HLTHCARE CORP Labeling Approval
10/11/2019 BUTORPHANOL TARTRATE
ANDA #075697		 SUPPL-15 BUTORPHANOL TARTRATE BAXTER HLTHCARE CORP Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076604		 SUPPL-23 HYDROCODONE BITARTRATE; IBUPROFEN ACTAVIS LABS FL INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077454		 SUPPL-5 HYDROCODONE BITARTRATE; IBUPROFEN ANI PHARMS INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723		 SUPPL-27 HYDROCODONE BITARTRATE; IBUPROFEN VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077727		 SUPPL-24 HYDROCODONE BITARTRATE; IBUPROFEN VINTAGE PHARMS Labeling Approval
10/11/2019 KETOROLAC TROMETHAMINE
ANDA #078737		 SUPPL-3 KETOROLAC TROMETHAMINE SUN PHARM Labeling Approval
10/11/2019 MORPHINE SULFATE
ANDA #079040		 SUPPL-21 MORPHINE SULFATE ACTAVIS ELIZABETH Labeling Approval
10/11/2019 OXYMORPHONE HYDROCHLORIDE
ANDA #079087		 SUPPL-38 OXYMORPHONE HYDROCHLORIDE IMPAX LABS Labeling Approval
10/11/2019 MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #081002		 SUPPL-10 MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
10/11/2019 MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #081309		 SUPPL-10 MEPERIDINE HYDROCHLORIDE INTL MEDICATION Labeling Approval
10/11/2019 OXYCET
ANDA #087463		 SUPPL-45 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #090118		 SUPPL-32 ACETAMINOPHEN; HYDROCODONE BITARTRATE SUN PHARM INDS INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #090415		 SUPPL-18 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #090415		 SUPPL-20 ACETAMINOPHEN; HYDROCODONE BITARTRATE VINTAGE PHARMS Labeling Approval
10/11/2019 POLYETHYLENE GLYCOL 3350
ANDA #090685		 SUPPL-9 POLYETHYLENE GLYCOL 3350 PERRIGO R AND D Manufacturing (CMC) Approval
10/11/2019 METHADONE HYDROCHLORIDE
ANDA #090707		 SUPPL-23 METHADONE HYDROCHLORIDE VISTAPHARM Labeling Approval
10/11/2019 TRAMADOL HYDROCHLORIDE
ANDA #091607		 SUPPL-19 TRAMADOL HYDROCHLORIDE SUN PHARM Labeling Approval
10/11/2019 TRAMADOL HYDROCHLORIDE
ANDA #091609		 SUPPL-9 TRAMADOL HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #091633		 SUPPL-11 HYDROCODONE BITARTRATE; IBUPROFEN SUN PHARM INDS INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #200343		 SUPPL-11 ACETAMINOPHEN; HYDROCODONE BITARTRATE VISTAPHARM Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #200463		 SUPPL-5 ITRACONAZOLE MYLAN PHARMS INC Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #200463		 SUPPL-6 ITRACONAZOLE MYLAN PHARMS INC Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #200463		 SUPPL-7 ITRACONAZOLE MYLAN PHARMS INC Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #200463		 SUPPL-8 ITRACONAZOLE MYLAN PHARMS INC Labeling Approval
10/11/2019 TRAMADOL HYDROCHLORIDE
ANDA #200491		 SUPPL-12 TRAMADOL HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #201013		 SUPPL-13 ACETAMINOPHEN; HYDROCODONE BITARTRATE AUROLIFE PHARMA LLC Labeling Approval
10/11/2019 GILOTRIF
NDA #201292		 SUPPL-15 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Labeling Approval
10/11/2019 TRAMADOL HYDROCHLORIDE
ANDA #201384		 SUPPL-17 TRAMADOL HYDROCHLORIDE SUN PHARM Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #202214		 SUPPL-10 ACETAMINOPHEN; HYDROCODONE BITARTRATE TRIS PHARMA INC Labeling Approval
10/11/2019 GLIPIZIDE
ANDA #202298		 SUPPL-4 GLIPIZIDE MYLAN Labeling Approval
10/11/2019 GLIPIZIDE
ANDA #202298		 SUPPL-6 GLIPIZIDE MYLAN Labeling Approval
10/11/2019 XARELTO
NDA #202439		 SUPPL-33 RIVAROXABAN JANSSEN PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #202935		 SUPPL-8 ACETAMINOPHEN; HYDROCODONE BITARTRATE PAR PHARM Labeling Approval
10/11/2019 OXYMORPHONE HYDROCHLORIDE
ANDA #202946		 SUPPL-10 OXYMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #202991		 SUPPL-6 ACETAMINOPHEN; HYDROCODONE BITARTRATE RHODES PHARMS Labeling Approval
10/11/2019 GLIPIZIDE
ANDA #203499		 SUPPL-1 GLIPIZIDE ZYDUS PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #203863		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE EPIC PHARMA LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #204575		 SUPPL-5 HYDROCODONE BITARTRATE; IBUPROFEN AUROLIFE PHARMA LLC Labeling Approval
10/11/2019 TREZIX
ANDA #204785		 SUPPL-9 ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE WRASER PHARMS LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #205001		 SUPPL-5 ACETAMINOPHEN; HYDROCODONE BITARTRATE PAR PHARM Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #205080		 SUPPL-1 ITRACONAZOLE AMNEAL PHARMS Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #205080		 SUPPL-2 ITRACONAZOLE AMNEAL PHARMS Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #205080		 SUPPL-3 ITRACONAZOLE AMNEAL PHARMS Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #205080		 SUPPL-4 ITRACONAZOLE AMNEAL PHARMS Labeling Approval
10/11/2019 TRAMADOL HYDROCHLORIDE
ANDA #205257		 SUPPL-8 TRAMADOL HYDROCHLORIDE MYLAN Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206142		 SUPPL-6 ACETAMINOPHEN; HYDROCODONE BITARTRATE NOVEL LABS INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206245		 SUPPL-8 ACETAMINOPHEN; HYDROCODONE BITARTRATE NOVEL LABS INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206470		 SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE ACTAVIS LABS FL INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206484		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE UPSHER SMITH LABS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206718		 SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE SPECGX LLC Labeling Approval
10/11/2019 GLIPIZIDE
ANDA #206928		 SUPPL-2 GLIPIZIDE AUROBINDO PHARMA LTD Labeling Approval
10/11/2019 GLIPIZIDE
ANDA #206928		 SUPPL-4 GLIPIZIDE AUROBINDO PHARMA LTD Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207171		 SUPPL-5 ACETAMINOPHEN; HYDROCODONE BITARTRATE LANNETT CO INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207172		 SUPPL-5 ACETAMINOPHEN; HYDROCODONE BITARTRATE LANNETT CO INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207509		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE WES PHARMA INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207509		 SUPPL-2 ACETAMINOPHEN; HYDROCODONE BITARTRATE WES PHARMA INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207709		 SUPPL-2 ACETAMINOPHEN; HYDROCODONE BITARTRATE AUROLIFE PHARMA LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207808		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE RHODES PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #208540		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ALVOGEN PINE BROOK Labeling Approval
10/11/2019 LYNPARZA
NDA #208558		 SUPPL-12 OLAPARIB ASTRAZENECA PHARMS Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #208591		 SUPPL-2 ITRACONAZOLE ALKEM LABS LTD Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #208591		 SUPPL-3 ITRACONAZOLE ALKEM LABS LTD Labeling Approval
10/11/2019 ITRACONAZOLE
ANDA #208591		 SUPPL-4 ITRACONAZOLE ALKEM LABS LTD Labeling Approval
10/11/2019 BETAMETHASONE DIPROPIONATE
ANDA #208849		 ORIG-1 BETAMETHASONE DIPROPIONATE HI TECH Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209036		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE ABHAI LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209037		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE ABHAI LLC Labeling Approval
10/11/2019 ATORVASTATIN CALCIUM
ANDA #209288		 SUPPL-1 ATORVASTATIN CALCIUM THEPHARMANETWORK LLC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209924		 SUPPL-2 ACETAMINOPHEN; HYDROCODONE BITARTRATE ELITE LABS INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209958		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ALVOGEN PINE BROOK Labeling Approval
10/11/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #210079		 SUPPL-3 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE NESHER PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #210211		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE WES PHARMA INC Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #210211		 SUPPL-4 ACETAMINOPHEN; HYDROCODONE BITARTRATE WES PHARMA INC Labeling Approval
10/11/2019 REYVOW
NDA #211280		 ORIG-1 LASMIDITAN SUCCINATE ELI LILLY AND CO Type 1 - New Molecular Entity Approval
10/11/2019 LEVORPHANOL TARTRATE
ANDA #211484		 SUPPL-1 LEVORPHANOL TARTRATE VIRTUS PHARMS Labeling Approval
10/11/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #211487		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ASCENT PHARMS INC Labeling Approval
10/11/2019 VUMERITY
NDA #211855		 ORIG-1 DIROXIMEL FUMARATE ALKERMES Type 2 - New Active Ingredient Tentative Approval
10/11/2019 SECUADO
NDA #212268		 ORIG-1 ASENAPINE HISAMITSU PHARM CO Type 3 - New Dosage Form Approval
10/13/2019 KETOROLAC TROMETHAMINE
ANDA #076583		 SUPPL-3 KETOROLAC TROMETHAMINE SANDOZ INC Labeling Approval
10/15/2019 KETOROLAC TROMETHAMINE
ANDA #078434		 SUPPL-3 KETOROLAC TROMETHAMINE AKORN Labeling Approval
10/15/2019 ADCETRIS
BLA #125388		 SUPPL-100 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
10/15/2019 FEBUXOSTAT
ANDA #205414		 ORIG-1 FEBUXOSTAT WEST-WARD PHARMS INT Approval
10/15/2019 NALOXONE HYDROCHLORIDE
ANDA #212455		 ORIG-1 NALOXONE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
10/16/2019 CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
ANDA #040118		 SUPPL-19 ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE SANDOZ Labeling Approval
10/16/2019 NALBUPHINE HYDROCHLORIDE
ANDA #070914		 SUPPL-20 NALBUPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
10/16/2019 NALBUPHINE HYDROCHLORIDE
ANDA #070915		 SUPPL-28 NALBUPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
10/16/2019 NALBUPHINE HYDROCHLORIDE
ANDA #070916		 SUPPL-19 NALBUPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
10/16/2019 NALBUPHINE HYDROCHLORIDE
ANDA #070918		 SUPPL-28 NALBUPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
10/16/2019 OFLOXACIN
ANDA #091656		 SUPPL-5 OFLOXACIN CADILA PHARMS LTD Labeling Approval
10/16/2019 ATORVASTATIN CALCIUM
ANDA #204991		 SUPPL-2 ATORVASTATIN CALCIUM LUPIN LTD Labeling Approval
10/16/2019 DAKLINZA
NDA #206843		 SUPPL-8 DACLATASVIR DIHYDROCHLORIDE BRISTOL-MYERS SQUIBB Labeling Approval
10/16/2019 TADALAFIL
ANDA #207290		 ORIG-1 TADALAFIL MACLEODS PHARMS LTD Approval
10/16/2019 ATORVASTATIN CALCIUM
ANDA #207687		 SUPPL-1 ATORVASTATIN CALCIUM ACCORD HLTHCARE Labeling Approval
10/16/2019 ATORVASTATIN CALCIUM
ANDA #207687		 SUPPL-4 ATORVASTATIN CALCIUM ACCORD HLTHCARE Labeling Approval
10/16/2019 BELBUCA
NDA #207932		 SUPPL-10 BUPRENORPHINE HYDROCHLORIDE BDSI Labeling Approval
10/16/2019 ABIRATERONE ACETATE
ANDA #209227		 ORIG-1 ABIRATERONE ACETATE GLENMARK PHARMS Approval
10/16/2019 XOFLUZA
NDA #210854		 SUPPL-1 BALOXAVIR MARBOXIL GENENTECH INC Efficacy Approval
10/16/2019 EFINACONAZOLE
ANDA #211827		 ORIG-1 EFINACONAZOLE TEVA PHARMS USA Tentative Approval
10/16/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #212376		 ORIG-1 ESOMEPRAZOLE MAGNESIUM MYLAN Approval
10/16/2019 NEOSTIGMINE METHYLSULFATE
ANDA #212968		 ORIG-1 NEOSTIGMINE METHYLSULFATE GLAND PHARMA LTD Approval
10/17/2019 BENICAR
NDA #021286		 SUPPL-40 OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Approval
10/17/2019 GEMCITABINE HYDROCHLORIDE
ANDA #078759		 SUPPL-6 GEMCITABINE HYDROCHLORIDE CIPLA Labeling Approval
10/17/2019 ZALEPLON
ANDA #078829		 SUPPL-10 ZALEPLON AUROBINDO PHARMA Labeling Approval
10/17/2019 ZALEPLON
ANDA #078829		 SUPPL-12 ZALEPLON AUROBINDO PHARMA Labeling Approval
10/17/2019 METOPROLOL SUCCINATE
ANDA #090615		 SUPPL-2 METOPROLOL SUCCINATE WOCKHARDT Labeling Approval
10/17/2019 REPAGLINIDE
ANDA #091517		 SUPPL-1 REPAGLINIDE BOSCOGEN Labeling Approval
10/17/2019 REPAGLINIDE
ANDA #091517		 SUPPL-2 REPAGLINIDE BOSCOGEN Labeling Approval
10/17/2019 GEMCITABINE HYDROCHLORIDE
ANDA #091594		 SUPPL-12 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/17/2019 GEMCITABINE HYDROCHLORIDE
ANDA #091594		 SUPPL-13 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/17/2019 GEMCITABINE HYDROCHLORIDE
ANDA #091594		 SUPPL-14 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/17/2019 NPLATE
BLA #125268		 SUPPL-164 ROMIPLOSTIM AMGEN Approval
10/17/2019 PARICALCITOL
NDA #207174		 SUPPL-6 PARICALCITOL ACCORD HLTHCARE Labeling Approval
10/17/2019 PEMETREXED SODIUM
ANDA #207352		 ORIG-1 PEMETREXED SODIUM NANG KUANG PHARM CO Tentative Approval
10/17/2019 PIROXICAM
ANDA #208340		 SUPPL-3 PIROXICAM UNICHEM LABS LTD Labeling Approval
10/17/2019 PIROXICAM
ANDA #209256		 SUPPL-4 PIROXICAM HIKMA PHARMS Labeling Approval
10/17/2019 ACETAZOLAMIDE
ANDA #210588		 ORIG-1 ACETAZOLAMIDE NOVITIUM PHARMA Approval
10/17/2019 TAMSULOSIN HYDROCHLORIDE
ANDA #211885		 ORIG-1 TAMSULOSIN HYDROCHLORIDE ANBISON LAB Approval
10/17/2019 LIDOCAINE
ANDA #212486		 ORIG-1 LIDOCAINE SUNGEN PHARMA Approval
10/17/2019 UDENYCA
BLA #761039		 SUPPL-4 PEGFILGRASTIM-CBQV COHERUS BIOSCIENCES INC Approval
10/18/2019 LIVALO
NDA #022363		 SUPPL-17 PITAVASTATIN CALCIUM KOWA CO Labeling Approval
10/18/2019 KETOROLAC TROMETHAMINE
ANDA #074955		 SUPPL-4 KETOROLAC TROMETHAMINE WATSON LABS Labeling Approval
10/18/2019 DESLORATADINE
ANDA #078357		 SUPPL-5 DESLORATADINE ORCHID HLTHCARE Labeling Approval
10/18/2019 KETOROLAC TROMETHAMINE
ANDA #078721		 SUPPL-3 KETOROLAC TROMETHAMINE SANDOZ INC Labeling Approval
10/18/2019 BOTOX
BLA #103000		 SUPPL-5310 OnabotulinumtoxinA ALLERGAN Approval
10/18/2019 BOTOX COSMETIC
BLA #103000		 SUPPL-5310 OnabotulinumtoxinA ALLERGAN Approval
10/18/2019 STELARA
BLA #125261		 SUPPL-152 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
10/18/2019 FARXIGA
NDA #202293		 SUPPL-18 DAPAGLIFLOZIN ASTRAZENECA AB Efficacy Approval
10/18/2019 KETOROLAC TROMETHAMINE
ANDA #203376		 SUPPL-1 KETOROLAC TROMETHAMINE AKORN Labeling Approval
10/18/2019 ORENITRAM
NDA #203496		 SUPPL-11 TREPROSTINIL DIOLAMINE UNITED THERAP Efficacy Approval
10/18/2019 VAZCULEP
NDA #204300		 SUPPL-8 PHENYLEPHRINE HYDROCHLORIDE AVADEL LEGACY Labeling Approval
10/18/2019 XIGDUO XR
NDA #205649		 SUPPL-11 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Efficacy Approval
10/18/2019 TIGECYCLINE
ANDA #205722		 ORIG-1 TIGECYCLINE XELLIA PHARMS APS Approval
10/18/2019 ATORVASTATIN CALCIUM
ANDA #206536		 SUPPL-3 ATORVASTATIN CALCIUM ZYDUS PHARMS Labeling Approval
10/18/2019 DIVALPROEX SODIUM
ANDA #209286		 ORIG-1 DIVALPROEX SODIUM LUPIN LTD Approval
10/18/2019 GENTAMICIN SULFATE
ANDA #209304		 ORIG-1 GENTAMICIN SULFATE TELIGENT PHARMA INC Approval
10/18/2019 CLENPIQ
NDA #209589		 SUPPL-6 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FERRING PHARMS INC Efficacy Approval
10/18/2019 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #211075		 ORIG-1 FEXOFENADINE HYDROCHLORIDE GRANULES INDIA LTD Approval
10/18/2019 SIROLIMUS
ANDA #211212		 ORIG-1 SIROLIMUS AMNEAL PHARMS LLC Approval
10/18/2019 ACETAZOLAMIDE
ANDA #211556		 ORIG-1 ACETAZOLAMIDE EYWA PHARMA Approval
10/18/2019 AMZEEQ
NDA #212379		 ORIG-1 MINOCYCLINE HYDROCHLORIDE FOAMIX PHARMA INC Approval
10/18/2019 ERELZI
BLA #761042		 SUPPL-10 ETANERCEPT-SZZS SANDOZ Approval
10/18/2019 STELARA
BLA #761044		 SUPPL-3 USTEKINUMAB JANSSEN BIOTECH Approval
10/18/2019 ULTOMIRIS
BLA #761108		 SUPPL-1 RAVULIZUMAB-CWVZ ALEXION PHARM Approval
10/21/2019 FIASP
NDA #208751		 SUPPL-8 INSULIN ASPART NOVO Efficacy Approval
10/21/2019 FIASP
NDA #208751		 SUPPL-13 INSULIN ASPART NOVO Labeling Approval
10/21/2019 FIASP FLEXTOUCH
NDA #208751		 SUPPL-8 INSULIN ASPART NOVO Efficacy Approval
10/21/2019 FIASP FLEXTOUCH
NDA #208751		 SUPPL-13 INSULIN ASPART NOVO Labeling Approval
10/21/2019 FIASP PENFILL
NDA #208751		 SUPPL-8 INSULIN ASPART NOVO Efficacy Approval
10/21/2019 FIASP PENFILL
NDA #208751		 SUPPL-13 INSULIN ASPART NOVO Labeling Approval
10/21/2019 CINVANTI
NDA #209296		 SUPPL-4 APREPITANT HERON THERAPS INC Efficacy Approval
10/21/2019 TRIENTINE HYDROCHLORIDE
ANDA #209731		 ORIG-1 TRIENTINE HYDROCHLORIDE KADMON PHARMS LLC Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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