Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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.

 

< Previous Month     Next Month >
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English