09/01/2021 |
ESTRADIOL NDA #020538 |
SUPPL-40 |
ESTRADIOL |
SANDOZ |
Labeling |
Approval |
09/01/2021 |
VIVELLE-DOT NDA #020538 |
SUPPL-40 |
ESTRADIOL |
SANDOZ |
Labeling |
Approval |
09/01/2021 |
OPTISON NDA #020899 |
SUPPL-23 |
ALBUMIN HUMAN |
GE HEALTHCARE |
Labeling |
Approval |
09/01/2021 |
ZYVOX NDA #021130 |
SUPPL-42 |
LINEZOLID |
PFIZER |
Labeling |
Approval |
09/01/2021 |
ZYVOX NDA #021131 |
SUPPL-38 |
LINEZOLID |
PFIZER |
Labeling |
Approval |
09/01/2021 |
ZYVOX NDA #021132 |
SUPPL-41 |
LINEZOLID |
PFIZER |
Labeling |
Approval |
09/01/2021 |
ONDANSETRON HYDROCHLORIDE ANDA #077473 |
SUPPL-10 |
ONDANSETRON HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
09/01/2021 |
ONDANSETRON HYDROCHLORIDE ANDA #077473 |
SUPPL-13 |
ONDANSETRON HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
09/01/2021 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #077548 |
SUPPL-11 |
ONDANSETRON HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
09/01/2021 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #077548 |
SUPPL-14 |
ONDANSETRON HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
09/01/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #078572 |
SUPPL-7 |
FLUOXETINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/01/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #078572 |
SUPPL-8 |
FLUOXETINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/01/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #078572 |
SUPPL-9 |
FLUOXETINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/01/2021 |
IRBESARTAN ANDA #203081 |
SUPPL-18 |
IRBESARTAN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/01/2021 |
ONDANSETRON HYDROCHLORIDE ANDA #203711 |
SUPPL-2 |
ONDANSETRON HYDROCHLORIDE |
QILU PHARM HAINAN |
Labeling |
Approval |
09/01/2021 |
ONDANSETRON HYDROCHLORIDE ANDA #203711 |
SUPPL-10 |
ONDANSETRON HYDROCHLORIDE |
QILU PHARM HAINAN |
Labeling |
Approval |
09/02/2021 |
LOESTRIN 24 FE NDA #021871 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
09/02/2021 |
DIAZEPAM ANDA #071308 |
SUPPL-8 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
09/02/2021 |
HYDROCODONE ANDA #077723 |
SUPPL-31 |
HYDROCODONE BITARTRATE; IBUPROFEN |
NOSTRUM LABS INC |
Labeling |
Approval |
09/02/2021 |
HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077723 |
SUPPL-31 |
HYDROCODONE BITARTRATE; IBUPROFEN |
NOSTRUM LABS INC |
Labeling |
Approval |
09/02/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #078627 |
SUPPL-12 |
VENLAFAXINE HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
09/02/2021 |
BRIVIACT NDA #205836 |
SUPPL-11 |
BRIVARACETAM |
UCB INC |
Labeling |
Approval |
09/02/2021 |
BRIVIACT NDA #205837 |
SUPPL-9 |
BRIVARACETAM |
UCB INC |
Labeling |
Approval |
09/02/2021 |
BRIVIACT NDA #205838 |
SUPPL-8 |
BRIVARACETAM |
UCB INC |
Labeling |
Approval |
09/02/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #206937 |
SUPPL-3 |
FLUOXETINE HYDROCHLORIDE |
TORRENT |
Labeling |
Approval |
09/02/2021 |
DAPTOMYCIN ANDA #213171 |
ORIG-1 |
DAPTOMYCIN |
EUGIA PHARMA |
|
Approval |
09/02/2021 |
TRUDHESA NDA #213436 |
ORIG-1 |
DIHYDROERGOTAMINE MESYLATE |
IMPEL PHARMS |
Type 5 - New Formulation or New Manufacturer |
Approval |
09/02/2021 |
ATORVASTATIN CALCIUM ANDA #214969 |
ORIG-1 |
ATORVASTATIN CALCIUM |
AGNITIO |
|
Approval |
09/02/2021 |
HEMLIBRA BLA #761083 |
SUPPL-11 |
EMICIZUMAB |
GENENTECH INC |
|
Approval |
09/03/2021 |
OLANZAPINE ANDA #076534 |
SUPPL-5 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/03/2021 |
OLANZAPINE ANDA #076534 |
SUPPL-6 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/03/2021 |
OLANZAPINE ANDA #076534 |
SUPPL-7 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/03/2021 |
OLANZAPINE ANDA #076534 |
SUPPL-8 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/03/2021 |
OLANZAPINE ANDA #076534 |
SUPPL-9 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/03/2021 |
OLANZAPINE ANDA #076534 |
SUPPL-10 |
OLANZAPINE |
DR REDDYS LABS LTD |
Manufacturing (CMC) |
Approval |
09/03/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077043 |
SUPPL-15 |
CITALOPRAM HYDROBROMIDE |
HIKMA |
Labeling |
Approval |
09/03/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #078554 |
SUPPL-8 |
VENLAFAXINE HYDROCHLORIDE |
HERITAGE |
Labeling |
Approval |
09/03/2021 |
LATANOPROST ANDA #201006 |
SUPPL-13 |
LATANOPROST |
BAUSCH AND LOMB |
Labeling |
Approval |
09/03/2021 |
ESCITALOPRAM OXALATE ANDA #202227 |
SUPPL-5 |
ESCITALOPRAM OXALATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/03/2021 |
ESCITALOPRAM OXALATE ANDA #202227 |
SUPPL-6 |
ESCITALOPRAM OXALATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/03/2021 |
ESCITALOPRAM OXALATE ANDA #202227 |
SUPPL-10 |
ESCITALOPRAM OXALATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/03/2021 |
ESCITALOPRAM OXALATE ANDA #202754 |
SUPPL-1 |
ESCITALOPRAM OXALATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/03/2021 |
ESCITALOPRAM OXALATE ANDA #202754 |
SUPPL-5 |
ESCITALOPRAM OXALATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/03/2021 |
RAVICTI NDA #203284 |
SUPPL-12 |
GLYCEROL PHENYLBUTYRATE |
HORIZON THERAP US |
Labeling |
Approval |
09/03/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #206250 |
SUPPL-1 |
VENLAFAXINE HYDROCHLORIDE |
CADILA PHARMS LTD |
Labeling |
Approval |
09/03/2021 |
ALECENSA NDA #208434 |
SUPPL-12 |
ALECTINIB HYDROCHLORIDE |
HOFFMANN-LA ROCHE |
Labeling |
Approval |
09/03/2021 |
TESTOSTERONE ANDA #209836 |
ORIG-1 |
TESTOSTERONE |
TWI PHARMS |
|
Approval |
09/03/2021 |
METRONIDAZOLE ANDA #212646 |
ORIG-1 |
METRONIDAZOLE |
ALEMBIC |
|
Approval |
09/03/2021 |
CHLOROQUINE PHOSPHATE ANDA #214756 |
ORIG-1 |
CHLOROQUINE PHOSPHATE |
SUVEN PHARMS |
|
Approval |
09/03/2021 |
DEXMEDETOMIDINE HYDROCHLORIDE ANDA #214794 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
PIRAMAL CRITICAL |
|
Approval |
09/03/2021 |
PAROXETINE HYDROCHLORIDE ANDA #215003 |
ORIG-1 |
PAROXETINE HYDROCHLORIDE |
NOVITIUM PHARMA |
|
Approval |
09/07/2021 |
FORTEO NDA #021318 |
SUPPL-56 |
TERIPARATIDE |
LILLY |
Labeling |
Approval |
09/07/2021 |
NEXTERONE NDA #022325 |
SUPPL-16 |
AMIODARONE HYDROCHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
09/07/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #077849 |
SUPPL-11 |
FLUOXETINE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
09/07/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #077849 |
SUPPL-12 |
FLUOXETINE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
09/07/2021 |
ESCITALOPRAM OXALATE ANDA #079062 |
SUPPL-9 |
ESCITALOPRAM OXALATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/07/2021 |
ESCITALOPRAM OXALATE ANDA #079062 |
SUPPL-11 |
ESCITALOPRAM OXALATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/07/2021 |
ESCITALOPRAM OXALATE ANDA #079062 |
SUPPL-14 |
ESCITALOPRAM OXALATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/07/2021 |
ESCITALOPRAM OXALATE ANDA #079062 |
SUPPL-15 |
ESCITALOPRAM OXALATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/07/2021 |
ERLEADA NDA #210951 |
SUPPL-6 |
APALUTAMIDE |
JANSSEN BIOTECH |
Efficacy |
Approval |
09/07/2021 |
MELPHALAN ANDA #212810 |
ORIG-1 |
MELPHALAN |
ALEMBIC GLOBAL |
|
Tentative Approval |
09/07/2021 |
EPTIFIBATIDE ANDA #213081 |
ORIG-1 |
EPTIFIBATIDE |
SHUANGCHENG |
|
Approval |
09/07/2021 |
AMPHETAMINE SULFATE ANDA #213852 |
ORIG-1 |
AMPHETAMINE SULFATE |
RHODES PHARMS |
|
Approval |
09/07/2021 |
ESOMEPRAZOLE MAGNESIUM NDA #214278 |
SUPPL-1 |
ESOMEPRAZOLE MAGNESIUM |
DEXCEL |
Labeling |
Approval |
09/07/2021 |
LABETALOL HYDROCHLORIDE ANDA #214533 |
ORIG-1 |
LABETALOL HYDROCHLORIDE |
CAPLIN |
|
Approval |
09/08/2021 |
ESCITALOPRAM OXALATE ANDA #079121 |
SUPPL-8 |
ESCITALOPRAM OXALATE |
TARO |
Labeling |
Approval |
09/08/2021 |
ESCITALOPRAM OXALATE ANDA #079121 |
SUPPL-9 |
ESCITALOPRAM OXALATE |
TARO |
Labeling |
Approval |
09/08/2021 |
ESCITALOPRAM OXALATE ANDA #079121 |
SUPPL-10 |
ESCITALOPRAM OXALATE |
TARO |
Labeling |
Approval |
09/08/2021 |
ESCITALOPRAM OXALATE ANDA #090477 |
SUPPL-4 |
ESCITALOPRAM OXALATE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/08/2021 |
ESCITALOPRAM OXALATE ANDA #090477 |
SUPPL-5 |
ESCITALOPRAM OXALATE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/08/2021 |
ESCITALOPRAM OXALATE ANDA #090477 |
SUPPL-6 |
ESCITALOPRAM OXALATE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/08/2021 |
RILUZOLE ANDA #091300 |
SUPPL-1 |
RILUZOLE |
APOTEX CORP |
Labeling |
Approval |
09/08/2021 |
RILUZOLE ANDA #091300 |
SUPPL-4 |
RILUZOLE |
APOTEX CORP |
Labeling |
Approval |
09/08/2021 |
RILUZOLE ANDA #203042 |
SUPPL-1 |
RILUZOLE |
MYLAN PHARMS INC |
Labeling |
Approval |
09/08/2021 |
RILUZOLE ANDA #203042 |
SUPPL-3 |
RILUZOLE |
MYLAN PHARMS INC |
Labeling |
Approval |
09/08/2021 |
DALFAMPRIDINE ANDA #206836 |
SUPPL-2 |
DALFAMPRIDINE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
09/08/2021 |
DALFAMPRIDINE ANDA #206858 |
SUPPL-1 |
DALFAMPRIDINE |
RISING |
Labeling |
Approval |
09/08/2021 |
LACTULOSE ANDA #207786 |
SUPPL-2 |
LACTULOSE |
APOZEAL PHARMS |
Manufacturing (CMC) |
Approval |
09/08/2021 |
DALFAMPRIDINE ANDA #208292 |
SUPPL-4 |
DALFAMPRIDINE |
SUN PHARM |
Labeling |
Approval |
09/08/2021 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE ANDA #208475 |
ORIG-1 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
B BRAUN MEDICAL INC |
|
Approval |
09/08/2021 |
ELIGLUSTAT TARTRATE ANDA #212463 |
ORIG-1 |
ELIGLUSTAT TARTRATE |
AIZANT |
|
Approval |
09/08/2021 |
HALCINONIDE ANDA #214723 |
ORIG-1 |
HALCINONIDE |
CHARTWELL RX |
|
Approval |
09/08/2021 |
OBETICHOLIC ANDA #214810 |
ORIG-1 |
OBETICHOLIC ACID |
AMNEAL PHARMS NY |
|
Tentative Approval |
09/09/2021 |
GABAPENTIN ANDA #078926 |
SUPPL-18 |
GABAPENTIN |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
09/09/2021 |
TYBOST NDA #203094 |
SUPPL-16 |
COBICISTAT |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/09/2021 |
STRIBILD NDA #203100 |
SUPPL-36 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/09/2021 |
TALZENNA NDA #211651 |
SUPPL-7 |
TALAZOPARIB TOSYLATE |
PFIZER |
Efficacy |
Approval |
09/09/2021 |
CYCLOPHOSPHAMIDE NDA #212501 |
SUPPL-2 |
CYCLOPHOSPHAMIDE |
DR REDDYS |
Labeling |
Approval |
09/09/2021 |
AVSOLA BLA #761086 |
SUPPL-1 |
INFLIXIMAB-AXXQ |
AMGEN INC |
|
Approval |
09/10/2021 |
ULTRAM NDA #020281 |
SUPPL-49 |
TRAMADOL HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
09/10/2021 |
AVAPRO NDA #020757 |
SUPPL-74 |
IRBESARTAN |
SANOFI AVENTIS US |
Labeling |
Approval |
09/10/2021 |
AVALIDE NDA #020758 |
SUPPL-80 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
SANOFI AVENTIS US |
Labeling |
Approval |
09/10/2021 |
ULTRACET NDA #021123 |
SUPPL-21 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
09/10/2021 |
CONZIP NDA #022370 |
SUPPL-23 |
TRAMADOL HYDROCHLORIDE |
CIPHER PHARMS INC |
Labeling |
Approval |
09/10/2021 |
TRAMADOL HYDROCHLORIDE ANDA #078783 |
SUPPL-13 |
TRAMADOL HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
09/10/2021 |
TRAMADOL HYDROCHLORIDE ANDA #091607 |
SUPPL-26 |
TRAMADOL HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
09/10/2021 |
TRAMADOL HYDROCHLORIDE ANDA #091609 |
SUPPL-11 |
TRAMADOL HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
09/10/2021 |
TRAMADOL HYDROCHLORIDE ANDA #200491 |
SUPPL-16 |
TRAMADOL HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
09/10/2021 |
TRAMADOL HYDROCHLORIDE ANDA #200503 |
SUPPL-12 |
TRAMADOL HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
09/10/2021 |
TRAMADOL HYDROCHLORIDE ANDA #201384 |
SUPPL-23 |
TRAMADOL HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
09/10/2021 |
ADEMPAS NDA #204819 |
SUPPL-15 |
RIOCIGUAT |
BAYER HLTHCARE |
Labeling |
Approval |
09/10/2021 |
EPINEPHRINE NDA #205029 |
SUPPL-6 |
EPINEPHRINE |
BPI LABS |
Labeling |
Approval |
09/10/2021 |
TRAMADOL HYDROCHLORIDE ANDA #205257 |
SUPPL-10 |
TRAMADOL HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
09/10/2021 |
ODEFSEY NDA #208351 |
SUPPL-13 |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/10/2021 |
MAYZENT NDA #209884 |
SUPPL-5 |
SIPONIMOD |
NOVARTIS |
Labeling |
Approval |
09/10/2021 |
BIKTARVY NDA #210251 |
SUPPL-13 |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/10/2021 |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE ANDA #213484 |
ORIG-1 |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
BIONPHARMA |
|
Approval |
09/10/2021 |
QDOLO NDA #214044 |
SUPPL-1 |
TRAMADOL HYDROCHLORIDE |
ATHENA |
Labeling |
Approval |
09/12/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075292 |
SUPPL-20 |
FLUOXETINE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
09/13/2021 |
METHADOSE NDA #017116 |
SUPPL-43 |
METHADONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
09/13/2021 |
RIFAMPIN ANDA #064150 |
SUPPL-35 |
RIFAMPIN |
EPIC PHARMA LLC |
Labeling |
Approval |
09/13/2021 |
RIFAMPIN ANDA #065390 |
SUPPL-19 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/13/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077601 |
SUPPL-7 |
CITALOPRAM HYDROBROMIDE |
PHARM ASSOC |
Labeling |
Approval |
09/13/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077629 |
SUPPL-14 |
CITALOPRAM HYDROBROMIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/13/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077629 |
SUPPL-15 |
CITALOPRAM HYDROBROMIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/13/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077812 |
SUPPL-14 |
CITALOPRAM HYDROBROMIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/13/2021 |
CITALOPRAM HYDROBROMIDE ANDA #201450 |
SUPPL-1 |
CITALOPRAM HYDROBROMIDE |
HETERO LABS LTD III |
Labeling |
Approval |
09/13/2021 |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE ANDA #204287 |
ORIG-1 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MACLEODS PHARMS LTD |
|
Approval |
09/13/2021 |
GENVOYA NDA #207561 |
SUPPL-27 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/13/2021 |
EPHEDRINE SULFATE ANDA #209646 |
SUPPL-1 |
EPHEDRINE SULFATE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
09/13/2021 |
IBUPROFEN ANDA #214699 |
ORIG-1 |
IBUPROFEN |
ALKEM LABS LTD |
|
Approval |
09/14/2021 |
INFED NDA #017441 |
SUPPL-180 |
FERRIC OXYHYDROXIDE |
ALLERGAN |
Labeling |
Approval |
09/14/2021 |
METHOTREXATE PRESERVATIVE FREE ANDA #040266 |
SUPPL-12 |
METHOTREXATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
09/14/2021 |
METHOTREXATE PRESERVATIVE FREE ANDA #040266 |
SUPPL-16 |
METHOTREXATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
09/14/2021 |
RABEPRAZOLE SODIUM ANDA #076822 |
SUPPL-13 |
RABEPRAZOLE SODIUM |
TEVA PHARMS USA |
Labeling |
Approval |
09/14/2021 |
MECLIZINE HYDROCHLORIDE ANDA #084657 |
SUPPL-54 |
MECLIZINE HYDROCHLORIDE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
09/14/2021 |
RIFAMPIN ANDA #090034 |
SUPPL-15 |
RIFAMPIN |
LUPIN PHARMS |
Labeling |
Approval |
09/14/2021 |
IRBESARTAN ANDA #201531 |
SUPPL-10 |
IRBESARTAN |
LUPIN LTD |
Labeling |
Approval |
09/14/2021 |
IRBESARTAN ANDA #201531 |
SUPPL-11 |
IRBESARTAN |
LUPIN LTD |
Labeling |
Approval |
09/14/2021 |
HYDROXYCHLOROQUINE SULFATE ANDA #201691 |
SUPPL-6 |
HYDROXYCHLOROQUINE SULFATE |
ALKALOIDA ZRT |
Labeling |
Approval |
09/14/2021 |
RABEPRAZOLE SODIUM ANDA #202376 |
SUPPL-17 |
RABEPRAZOLE SODIUM |
TORRENT |
Labeling |
Approval |
09/14/2021 |
RABEPRAZOLE SODIUM ANDA #208644 |
SUPPL-10 |
RABEPRAZOLE SODIUM |
ALKEM LABS LTD |
Labeling |
Approval |
09/14/2021 |
CHOLESTYRAMINE ANDA #211119 |
SUPPL-6 |
CHOLESTYRAMINE |
AJANTA PHARMA LTD |
Labeling |
Approval |
09/14/2021 |
BRUKINSA NDA #213217 |
SUPPL-5 |
ZANUBRUTINIB |
BEIGENE |
Efficacy |
Approval |
09/15/2021 |
MONISTAT 3 NDA #020827 |
SUPPL-33 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
09/15/2021 |
VIMPAT NDA #022253 |
SUPPL-51 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
09/15/2021 |
VIMPAT NDA #022254 |
SUPPL-41 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
09/15/2021 |
VIMPAT NDA #022255 |
SUPPL-33 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
09/15/2021 |
MYCOBUTIN NDA #050689 |
SUPPL-26 |
RIFABUTIN |
PFIZER |
Labeling |
Approval |
09/15/2021 |
CEFUROXIME AXETIL ANDA #065359 |
SUPPL-10 |
CEFUROXIME AXETIL |
ANDA REPOSITORY |
Labeling |
Approval |
09/15/2021 |
ALPRAZOLAM ANDA #074112 |
SUPPL-36 |
ALPRAZOLAM |
SANDOZ |
Labeling |
Approval |
09/15/2021 |
OXYBUTYNIN CHLORIDE ANDA #075079 |
SUPPL-21 |
OXYBUTYNIN CHLORIDE |
STRIDES PHARMA |
Manufacturing (CMC) |
Approval |
09/15/2021 |
RIVASTIGMINE TARTRATE ANDA #077129 |
SUPPL-4 |
RIVASTIGMINE TARTRATE |
WATSON LABS |
Labeling |
Approval |
09/15/2021 |
RIVASTIGMINE TARTRATE ANDA #077129 |
SUPPL-5 |
RIVASTIGMINE TARTRATE |
WATSON LABS |
Labeling |
Approval |
09/15/2021 |
TAMSULOSIN HYDROCHLORIDE ANDA #078015 |
SUPPL-13 |
TAMSULOSIN HYDROCHLORIDE |
SANDOZ |
Manufacturing (CMC) |
Approval |
09/15/2021 |
TAMSULOSIN HYDROCHLORIDE ANDA #078015 |
SUPPL-14 |
TAMSULOSIN HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
09/15/2021 |
METOPROLOL TARTRATE ANDA #091045 |
SUPPL-3 |
METOPROLOL TARTRATE |
FRESENIUS KABI USA |
Labeling |
Approval |
09/15/2021 |
CLOPIDOGREL BISULFATE ANDA #202928 |
SUPPL-26 |
CLOPIDOGREL BISULFATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/15/2021 |
IRBESARTAN ANDA #203071 |
SUPPL-7 |
IRBESARTAN |
PRINSTON INC |
Labeling |
Approval |
09/15/2021 |
IRBESARTAN ANDA #203071 |
SUPPL-8 |
IRBESARTAN |
PRINSTON INC |
Labeling |
Approval |
09/15/2021 |
DALFAMPRIDINE ANDA #206765 |
SUPPL-6 |
DALFAMPRIDINE |
ALKEM LABS LTD |
Labeling |
Approval |
09/15/2021 |
DALFAMPRIDINE ANDA #206765 |
SUPPL-7 |
DALFAMPRIDINE |
ALKEM LABS LTD |
Labeling |
Approval |
09/15/2021 |
DESCOVY NDA #208215 |
SUPPL-19 |
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/15/2021 |
VEMLIDY NDA #208464 |
SUPPL-13 |
TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/15/2021 |
EZETIMIBE AND SIMVASTATIN ANDA #208831 |
SUPPL-6 |
EZETIMIBE; SIMVASTATIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
09/15/2021 |
KISQALI NDA #209092 |
SUPPL-9 |
RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
09/15/2021 |
KISQALI FEMARA CO-PACK (COPACKAGED) NDA #209935 |
SUPPL-13 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
09/15/2021 |
DALFAMPRIDINE ANDA #210158 |
SUPPL-4 |
DALFAMPRIDINE |
MICRO LABS |
Labeling |
Approval |
09/15/2021 |
EXKIVITY NDA #215310 |
ORIG-1 |
MOBOCERTINIB SUCCINATE |
TAKEDA PHARMS USA |
Type 1 - New Molecular Entity |
Approval |
09/16/2021 |
CLIMARA NDA #020375 |
SUPPL-45 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/16/2021 |
CLIMARA NDA #020375 |
SUPPL-46 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/16/2021 |
MENOSTAR NDA #020375 |
SUPPL-45 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/16/2021 |
MENOSTAR NDA #020375 |
SUPPL-46 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/16/2021 |
OPTISON NDA #020899 |
SUPPL-24 |
ALBUMIN HUMAN |
GE HEALTHCARE |
Labeling |
Approval |
09/16/2021 |
GRALISE NDA #022544 |
SUPPL-27 |
GABAPENTIN |
ALMATICA |
Manufacturing (CMC) |
Approval |
09/17/2021 |
CABOMETYX NDA #208692 |
SUPPL-12 |
CABOZANTINIB S-MALATE |
EXELIXIS INC |
Efficacy |
Approval |
09/17/2021 |
STEGLATRO NDA #209803 |
SUPPL-4 |
ERTUGLIFLOZIN |
MSD SUB MERCK |
Efficacy |
Approval |
09/17/2021 |
STEGLUJAN NDA #209805 |
SUPPL-8 |
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Efficacy |
Approval |
09/17/2021 |
SEGLUROMET NDA #209806 |
SUPPL-6 |
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE |
MSD SUB MERCK |
Efficacy |
Approval |
09/17/2021 |
QUINIDINE GLUCONATE ANDA #212589 |
ORIG-1 |
QUINIDINE GLUCONATE |
EYWA |
|
Approval |
09/17/2021 |
ACETAMINOPHEN ANDA #214331 |
ORIG-1 |
ACETAMINOPHEN |
BAXTER HLTHCARE CORP |
|
Approval |
09/17/2021 |
BYOOVIZ BLA #761202 |
ORIG-1 |
RANIBIZUMAB-NUNA |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
09/20/2021 |
ZOLOFT NDA #019839 |
SUPPL-100 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
09/20/2021 |
PAXIL NDA #020031 |
SUPPL-79 |
PAROXETINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
09/20/2021 |
EFFEXOR XR NDA #020699 |
SUPPL-114 |
VENLAFAXINE HYDROCHLORIDE |
UPJOHN |
Labeling |
Approval |
09/20/2021 |
PAXIL NDA #020710 |
SUPPL-47 |
PAROXETINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
09/20/2021 |
CELEXA NDA #020822 |
SUPPL-52 |
CITALOPRAM HYDROBROMIDE |
ABBVIE |
Labeling |
Approval |
09/20/2021 |
PAXIL CR NDA #020936 |
SUPPL-60 |
PAROXETINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
09/20/2021 |
ZOLOFT NDA #020990 |
SUPPL-57 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
09/20/2021 |
PEXEVA NDA #021299 |
SUPPL-37 |
PAROXETINE MESYLATE |
SEBELA IRELAND LTD |
Labeling |
Approval |
09/20/2021 |
LEXAPRO NDA #021323 |
SUPPL-53 |
ESCITALOPRAM OXALATE |
ABBVIE |
Labeling |
Approval |
09/20/2021 |
LEXAPRO NDA #021365 |
SUPPL-38 |
ESCITALOPRAM OXALATE |
ABBVIE |
Labeling |
Approval |
09/20/2021 |
CYMBALTA NDA #021427 |
SUPPL-56 |
DULOXETINE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
09/20/2021 |
LUVOX NDA #021519 |
SUPPL-18 |
FLUVOXAMINE MALEATE |
ANI PHARMS |
Labeling |
Approval |
09/20/2021 |
SYMBYAX NDA #021520 |
SUPPL-54 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
LILLY |
Labeling |
Approval |
09/20/2021 |
PREVANTICS MAXI SWABSTICK NDA #021524 |
SUPPL-24 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
PROF DSPLS |
Labeling |
Approval |
09/20/2021 |
PREVANTICS SWAB NDA #021524 |
SUPPL-24 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
PROF DSPLS |
Labeling |
Approval |
09/20/2021 |
PREVANTICS SWABSTICK NDA #021524 |
SUPPL-24 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
PROF DSPLS |
Labeling |
Approval |
09/20/2021 |
SARAFEM NDA #021860 |
SUPPL-15 |
FLUOXETINE HYDROCHLORIDE |
APIL |
Labeling |
Approval |
09/20/2021 |
PRISTIQ NDA #021992 |
SUPPL-48 |
DESVENLAFAXINE SUCCINATE |
PF PRISM CV |
Labeling |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE NDA #022104 |
SUPPL-21 |
VENLAFAXINE HYDROCHLORIDE |
OSMOTICA PHARM US |
Labeling |
Approval |
09/20/2021 |
VIMPAT NDA #022253 |
SUPPL-53 |
LACOSAMIDE |
UCB INC |
Manufacturing (CMC) |
Approval |
09/20/2021 |
SAVELLA NDA #022256 |
SUPPL-25 |
MILNACIPRAN HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
09/20/2021 |
VIIBRYD NDA #022567 |
SUPPL-22 |
VILAZODONE HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
09/20/2021 |
COLISTIMETHATE SODIUM ANDA #065177 |
SUPPL-15 |
COLISTIMETHATE SODIUM |
NEXUS |
Labeling |
Approval |
09/20/2021 |
ALPRAZOLAM ANDA #074174 |
SUPPL-11 |
ALPRAZOLAM |
NOVITIUM PHARMA |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075292 |
SUPPL-21 |
FLUOXETINE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075525 |
SUPPL-6 |
FLUOXETINE HYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075690 |
SUPPL-8 |
FLUOXETINE HYDROCHLORIDE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075755 |
SUPPL-26 |
FLUOXETINE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #076006 |
SUPPL-9 |
FLUOXETINE HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #076024 |
SUPPL-6 |
FLUOXETINE HYDROCHLORIDE |
FOSUN PHARMA |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #076287 |
SUPPL-9 |
FLUOXETINE HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #077166 |
SUPPL-18 |
VENLAFAXINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #077515 |
SUPPL-3 |
VENLAFAXINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
09/20/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077812 |
SUPPL-17 |
CITALOPRAM HYDROBROMIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #078045 |
SUPPL-10 |
FLUOXETINE HYDROCHLORIDE |
NATCO PHARMA USA |
Labeling |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #078301 |
SUPPL-9 |
VENLAFAXINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #078572 |
SUPPL-11 |
FLUOXETINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #078932 |
SUPPL-26 |
VENLAFAXINE HYDROCHLORIDE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
09/20/2021 |
ESCITALOPRAM OXALATE ANDA #079062 |
SUPPL-16 |
ESCITALOPRAM OXALATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #079098 |
SUPPL-13 |
VENLAFAXINE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #090555 |
SUPPL-19 |
VENLAFAXINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE NDA #202133 |
SUPPL-12 |
FLUOXETINE HYDROCHLORIDE |
TWI PHARMS |
Labeling |
Approval |
09/20/2021 |
ESCITALOPRAM OXALATE ANDA #202227 |
SUPPL-12 |
ESCITALOPRAM OXALATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/20/2021 |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE ANDA #203433 |
SUPPL-2 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
HIKMA |
Manufacturing (CMC) |
Approval |
09/20/2021 |
VANCOMYCIN HYDROCHLORIDE ANDA #204107 |
SUPPL-11 |
VANCOMYCIN HYDROCHLORIDE |
XELLIA PHARMS APS |
Labeling |
Approval |
09/20/2021 |
DESVENLAFAXINE NDA #204150 |
SUPPL-18 |
DESVENLAFAXINE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
09/20/2021 |
FETZIMA NDA #204168 |
SUPPL-7 |
LEVOMILNACIPRAN HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
09/20/2021 |
TRINTELLIX NDA #204447 |
SUPPL-24 |
VORTIOXETINE HYDROBROMIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
09/20/2021 |
BRISDELLE NDA #204516 |
SUPPL-11 |
PAROXETINE MESYLATE |
SEBELA IRELAND LTD |
Labeling |
Approval |
09/20/2021 |
KHEDEZLA NDA #204683 |
SUPPL-7 |
DESVENLAFAXINE |
OSMOTICA PHARM CORP |
Labeling |
Approval |
09/20/2021 |
BORTEZOMIB NDA #205004 |
SUPPL-3 |
BORTEZOMIB |
FRESENIUS KABI USA |
Efficacy |
Approval |
09/20/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #206250 |
SUPPL-2 |
VENLAFAXINE HYDROCHLORIDE |
CADILA PHARMS LTD |
Labeling |
Approval |
09/20/2021 |
CEFAZOLIN IN DEXTROSE NDA #207131 |
SUPPL-8 |
CEFAZOLIN SODIUM |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
09/20/2021 |
VERMOX NDA #208398 |
SUPPL-1 |
MEBENDAZOLE |
JANSSEN PHARMS |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #208698 |
SUPPL-18 |
FLUOXETINE HYDROCHLORIDE |
ALEMBIC |
Labeling |
Approval |
09/20/2021 |
TYMLOS NDA #208743 |
SUPPL-9 |
ABALOPARATIDE |
RADIUS |
Efficacy |
Approval |
09/20/2021 |
CLINDAMYCIN PHOSPHATE ANDA #210778 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
GLENMARK PHARMS LTD |
|
Approval |
09/20/2021 |
TALZENNA NDA #211651 |
SUPPL-8 |
TALAZOPARIB TOSYLATE |
PFIZER |
Labeling |
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #211653 |
SUPPL-2 |
FLUOXETINE HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
09/20/2021 |
FENOFIBRATE (MICRONIZED) ANDA #212232 |
ORIG-1 |
FENOFIBRATE |
AUROBINDO PHARMA LTD |
|
Approval |
09/20/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #213286 |
SUPPL-2 |
FLUOXETINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/20/2021 |
DECITABINE ANDA #214569 |
ORIG-1 |
DECITABINE |
EUGIA PHARMA |
|
Approval |
09/20/2021 |
TIVDAK BLA #761208 |
ORIG-1 |
TISOTUMAB VEDOTIN-TFTV |
SEAGEN |
|
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075506 |
SUPPL-25 |
FLUOXETINE HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075514 |
SUPPL-16 |
FLUOXETINE HYDROCHLORIDE |
PHARMOBEDIENT CNSLTG |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075872 |
SUPPL-32 |
FLUOXETINE HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #075920 |
SUPPL-18 |
FLUOXETINE HYDROCHLORIDE |
BAJAJ |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #076015 |
SUPPL-22 |
FLUOXETINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #076458 |
SUPPL-10 |
FLUOXETINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/21/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #076690 |
SUPPL-27 |
VENLAFAXINE HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
09/21/2021 |
OXYCODONE HYDROCHLORIDE ANDA #076758 |
SUPPL-16 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
09/21/2021 |
OXYCODONE HYDROCHLORIDE ANDA #076758 |
SUPPL-18 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
09/21/2021 |
OXYCODONE HYDROCHLORIDE ANDA #076758 |
SUPPL-20 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
09/21/2021 |
OXYCODONE HYDROCHLORIDE ANDA #076758 |
SUPPL-22 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
09/21/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077043 |
SUPPL-17 |
CITALOPRAM HYDROBROMIDE |
HIKMA |
Labeling |
Approval |
09/21/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077601 |
SUPPL-8 |
CITALOPRAM HYDROBROMIDE |
PHARM ASSOC |
Labeling |
Approval |
09/21/2021 |
CITALOPRAM HYDROBROMIDE ANDA #077629 |
SUPPL-16 |
CITALOPRAM HYDROBROMIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/21/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #077653 |
SUPPL-22 |
VENLAFAXINE HYDROCHLORIDE |
ZYDUS PHARMS USA |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #077849 |
SUPPL-13 |
FLUOXETINE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
09/21/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #078554 |
SUPPL-10 |
VENLAFAXINE HYDROCHLORIDE |
HERITAGE |
Labeling |
Approval |
09/21/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #078627 |
SUPPL-14 |
VENLAFAXINE HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
09/21/2021 |
ESCITALOPRAM OXALATE ANDA #079121 |
SUPPL-11 |
ESCITALOPRAM OXALATE |
TARO |
Labeling |
Approval |
09/21/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #090027 |
SUPPL-15 |
VENLAFAXINE HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
09/21/2021 |
ESCITALOPRAM OXALATE ANDA #090477 |
SUPPL-7 |
ESCITALOPRAM OXALATE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
09/21/2021 |
SELFEMRA ANDA #200151 |
SUPPL-7 |
FLUOXETINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
09/21/2021 |
FAMCICLOVIR ANDA #201333 |
SUPPL-2 |
FAMCICLOVIR |
NATCO PHARMA |
Labeling |
Approval |
09/21/2021 |
FAMCICLOVIR ANDA #201333 |
SUPPL-4 |
FAMCICLOVIR |
NATCO PHARMA |
Labeling |
Approval |
09/21/2021 |
FAMCICLOVIR ANDA #201333 |
SUPPL-5 |
FAMCICLOVIR |
NATCO PHARMA |
Labeling |
Approval |
09/21/2021 |
CITALOPRAM HYDROBROMIDE ANDA #201450 |
SUPPL-4 |
CITALOPRAM HYDROBROMIDE |
HETERO LABS LTD III |
Labeling |
Approval |
09/21/2021 |
VENLAFAXINE HYDROCHLORIDE ANDA #202036 |
SUPPL-6 |
VENLAFAXINE HYDROCHLORIDE |
YAOPHARMA CO LTD |
Labeling |
Approval |
09/21/2021 |
ESCITALOPRAM OXALATE ANDA #202221 |
SUPPL-6 |
ESCITALOPRAM OXALATE |
HETERO LABS LTD III |
Labeling |
Approval |
09/21/2021 |
ESCITALOPRAM OXALATE ANDA #202754 |
SUPPL-12 |
ESCITALOPRAM OXALATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #203836 |
SUPPL-1 |
FLUOXETINE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #206937 |
SUPPL-6 |
FLUOXETINE HYDROCHLORIDE |
TORRENT |
Labeling |
Approval |
09/21/2021 |
METHYLPREDNISOLONE ANDA #207481 |
ORIG-1 |
METHYLPREDNISOLONE |
AMNEAL |
|
Approval |
09/21/2021 |
CEFTAROLINE FOSAMIL ANDA #208075 |
ORIG-1 |
CEFTAROLINE FOSAMIL |
APOTEX |
|
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #210935 |
SUPPL-4 |
FLUOXETINE HYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
09/21/2021 |
TALZENNA NDA #211651 |
SUPPL-9 |
TALAZOPARIB TOSYLATE |
PFIZER |
Manufacturing (CMC) |
Approval |
09/21/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #211696 |
SUPPL-2 |
FLUOXETINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
09/21/2021 |
APREMILAST ANDA #211761 |
ORIG-1 |
APREMILAST |
ALKEM LABS LTD |
|
Approval |
09/21/2021 |
ISOTRETINOIN ANDA #212333 |
ORIG-1 |
ISOTRETINOIN |
UPSHER SMITH LABS |
|
Approval |
09/21/2021 |
OPZELURA NDA #215309 |
ORIG-1 |
RUXOLITINIB PHOSPHATE |
INCYTE CORP |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
09/22/2021 |
VOTRIENT NDA #022465 |
SUPPL-31 |
PAZOPANIB HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
09/22/2021 |
VOTRIENT NDA #022465 |
SUPPL-32 |
PAZOPANIB HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
09/22/2021 |
CEFUROXIME AXETIL ANDA #065308 |
SUPPL-20 |
CEFUROXIME AXETIL |
AUROBINDO PHARMA |
Labeling |
Approval |
09/22/2021 |
VINCRISTINE SULFATE PFS ANDA #071484 |
SUPPL-46 |
VINCRISTINE SULFATE |
HOSPIRA |
Labeling |
Approval |
09/22/2021 |
FAMOTIDINE PRESERVATIVE FREE ANDA #075486 |
SUPPL-17 |
FAMOTIDINE |
HIKMA |
Labeling |
Approval |
09/22/2021 |
FAMOTIDINE ANDA #075488 |
SUPPL-15 |
FAMOTIDINE |
HIKMA |
Labeling |
Approval |
09/22/2021 |
BACLOFEN ANDA #077241 |
SUPPL-21 |
BACLOFEN |
LANNETT CO INC |
Manufacturing (CMC) |
Approval |
09/22/2021 |
JAKAFI NDA #202192 |
SUPPL-23 |
RUXOLITINIB PHOSPHATE |
INCYTE CORP |
Efficacy |
Approval |
09/22/2021 |
XALKORI NDA #202570 |
SUPPL-31 |
CRIZOTINIB |
PF PRISM CV |
Labeling |
Approval |
09/22/2021 |
SUBLOCADE NDA #209819 |
SUPPL-19 |
BUPRENORPHINE |
INDIVIOR |
REMS |
Approval |
09/22/2021 |
COPIKTRA NDA #211155 |
SUPPL-3 |
DUVELISIB |
SECURA |
Labeling |
Approval |
09/22/2021 |
PROCHLORPERAZINE EDISYLATE ANDA #214107 |
ORIG-1 |
PROCHLORPERAZINE EDISYLATE |
GLAND PHARMA LTD |
|
Approval |
09/23/2021 |
TASIGNA NDA #022068 |
SUPPL-35 |
NILOTINIB HYDROCHLORIDE |
NOVARTIS |
Efficacy |
Approval |
09/23/2021 |
TASIGNA NDA #022068 |
SUPPL-36 |
NILOTINIB HYDROCHLORIDE |
NOVARTIS |
Efficacy |
Approval |
09/23/2021 |
SIRTURO NDA #204384 |
SUPPL-16 |
BEDAQUILINE FUMARATE |
JANSSEN THERAP |
Labeling |
Approval |
09/23/2021 |
MYCOPHENOLIC SODIUM ANDA #208315 |
ORIG-1 |
MYCOPHENOLIC SODIUM |
ALKEM LABS LTD |
|
Approval |
09/23/2021 |
BRIMONIDINE TARTRATE ANDA #209158 |
ORIG-1 |
BRIMONIDINE TARTRATE |
PADAGIS ISRAEL |
|
Approval |
09/23/2021 |
BUPRENORPHINE ANDA #210272 |
ORIG-1 |
BUPRENORPHINE |
AVEVA |
|
Approval |
09/23/2021 |
ELUXADOLINE ANDA #213576 |
ORIG-1 |
ELUXADOLINE |
MSN PHARMACEUTICALS INC |
|
Tentative Approval |
09/23/2021 |
VIGABATRIN ANDA #215109 |
ORIG-1 |
VIGABATRIN |
DEXCEL |
|
Approval |
09/24/2021 |
ERBITUX BLA #125084 |
SUPPL-279 |
CETUXIMAB |
IMCLONE |
|
Approval |
09/24/2021 |
REPATHA BLA #125522 |
SUPPL-29 |
EVOLOCUMAB |
AMGEN INC |
|
Approval |
09/24/2021 |
REPATHA BLA #125522 |
SUPPL-31 |
EVOLOCUMAB |
AMGEN INC |
|
Approval |
09/24/2021 |
VANCOMYCIN HYDROCHLORIDE ANDA #204125 |
SUPPL-11 |
VANCOMYCIN HYDROCHLORIDE |
XELLIA PHARMS APS |
Labeling |
Approval |
09/24/2021 |
ALUNBRIG NDA #208772 |
SUPPL-12 |
BRIGATINIB |
TAKEDA PHARMS USA |
Labeling |
Approval |
09/24/2021 |
TERIFLUNOMIDE ANDA #209583 |
ORIG-1 |
TERIFLUNOMIDE |
BRECKENRIDGE |
|
Approval |
09/24/2021 |
AJOVY BLA #761089 |
SUPPL-13 |
FREMANEZUMAB-VFRM |
TEVA PHARMS USA |
|
Approval |
09/24/2021 |
VYEPTI BLA #761119 |
SUPPL-2 |
EPTINEZUMAB-JJMR |
Lundbeck Seattle BioPharmaceuticals, Inc. |
|
Approval |
09/27/2021 |
HYCODAN NDA #005213 |
SUPPL-44 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
GENUS |
Manufacturing (CMC) |
Approval |
09/27/2021 |
ACETADOTE NDA #021539 |
SUPPL-20 |
ACETYLCYSTEINE |
CUMBERLAND PHARMS |
Labeling |
Approval |
09/27/2021 |
JAKAFI NDA #202192 |
SUPPL-25 |
RUXOLITINIB PHOSPHATE |
INCYTE CORP |
Labeling |
Approval |
09/27/2021 |
XOFLUZA NDA #214410 |
SUPPL-1 |
BALOXAVIR MARBOXIL |
GENENTECH INC |
Labeling |
Approval |
09/28/2021 |
CLOBAZAM ANDA #209308 |
SUPPL-6 |
CLOBAZAM |
BRECKENRIDGE |
Labeling |
Approval |
09/28/2021 |
MAVYRET NDA #209394 |
SUPPL-14 |
GLECAPREVIR; PIBRENTASVIR |
ABBVIE |
Labeling |
Approval |
09/28/2021 |
PROCHLORPERAZINE EDISYLATE ANDA #213626 |
ORIG-1 |
PROCHLORPERAZINE EDISYLATE |
VIWIT PHARM |
|
Approval |
09/28/2021 |
MAVYRET NDA #215110 |
SUPPL-1 |
GLECAPREVIR; PIBRENTASVIR |
ABBVIE |
Labeling |
Approval |
09/28/2021 |
QULIPTA NDA #215206 |
ORIG-1 |
ATOGEPANT |
ABBVIE |
Type 1 - New Molecular Entity |
Approval |
09/29/2021 |
ADDYI NDA #022526 |
SUPPL-10 |
FLIBANSERIN |
SPROUT PHARMS |
Labeling |
Approval |
09/29/2021 |
TADALAFIL ANDA #200630 |
SUPPL-5 |
TADALAFIL |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
09/29/2021 |
DECITABINE ANDA #202969 |
SUPPL-3 |
DECITABINE |
SANDOZ |
Labeling |
Approval |
09/29/2021 |
DECITABINE ANDA #202969 |
SUPPL-4 |
DECITABINE |
SANDOZ |
Labeling |
Approval |
09/29/2021 |
DECITABINE ANDA #202969 |
SUPPL-5 |
DECITABINE |
SANDOZ |
Labeling |
Approval |
09/29/2021 |
DECITABINE ANDA #203475 |
SUPPL-1 |
DECITABINE |
ACCORD HLTHCARE |
Labeling |
Approval |
09/29/2021 |
DECITABINE ANDA #203475 |
SUPPL-2 |
DECITABINE |
ACCORD HLTHCARE |
Labeling |
Approval |
09/29/2021 |
DECITABINE ANDA #203475 |
SUPPL-3 |
DECITABINE |
ACCORD HLTHCARE |
Labeling |
Approval |
09/29/2021 |
BUDESONIDE ANDA #206200 |
SUPPL-15 |
BUDESONIDE |
AMNEAL PHARMS |
Labeling |
Approval |
09/29/2021 |
DALFAMPRIDINE ANDA #206811 |
SUPPL-8 |
DALFAMPRIDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/29/2021 |
CLOBAZAM ANDA #209715 |
SUPPL-1 |
CLOBAZAM |
HIKMA |
Labeling |
Approval |
09/29/2021 |
AMITRIPTYLINE HYDROCHLORIDE ANDA #212654 |
SUPPL-1 |
AMITRIPTYLINE HYDROCHLORIDE |
AIPING PHARM INC |
Manufacturing (CMC) |
Approval |
09/29/2021 |
METFORMIN HYDROCHLORIDE ANDA #213247 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
TWI PHARMS |
|
Approval |
09/29/2021 |
VIGABATRIN ANDA #213899 |
ORIG-1 |
VIGABATRIN |
AUROBINDO PHARMA LTD |
|
Approval |
09/29/2021 |
LIVMARLI NDA #214662 |
ORIG-1 |
MARALIXIBAT CHLORIDE |
MIRUM |
Type 1 - New Molecular Entity |
Approval |
09/29/2021 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #214959 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ASCENT PHARMS INC |
|
Approval |
09/29/2021 |
INMAZEB BLA #761169 |
SUPPL-2 |
ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
09/30/2021 |
CLIMARA NDA #020375 |
SUPPL-36 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/30/2021 |
CLIMARA NDA #020375 |
SUPPL-37 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/30/2021 |
MENOSTAR NDA #020375 |
SUPPL-36 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/30/2021 |
MENOSTAR NDA #020375 |
SUPPL-37 |
ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #084610 |
SUPPL-41 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #084611 |
SUPPL-45 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #084612 |
SUPPL-32 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #084613 |
SUPPL-42 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #087916 |
SUPPL-29 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #088248 |
SUPPL-26 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #088306 |
SUPPL-29 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
DEXAMETHASONE ANDA #088316 |
SUPPL-25 |
DEXAMETHASONE |
HIKMA |
Labeling |
Approval |
09/30/2021 |
TRULICITY BLA #125469 |
SUPPL-44 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
09/30/2021 |
HALAVEN NDA #201532 |
SUPPL-21 |
ERIBULIN MESYLATE |
EISAI INC |
Labeling |
Approval |
09/30/2021 |
RUBRACA NDA #209115 |
SUPPL-9 |
RUCAPARIB CAMSYLATE |
PHARMAAND |
Labeling |
Approval |
09/30/2021 |
EPIDIOLEX NDA #210365 |
SUPPL-12 |
CANNABIDIOL |
JAZZ PHARMS RES |
Labeling |
Approval |
09/30/2021 |
EPIDIOLEX NDA #210365 |
SUPPL-13 |
CANNABIDIOL |
JAZZ PHARMS RES |
Labeling |
Approval |
09/30/2021 |
ZOLMITRIPTAN ANDA #212469 |
ORIG-1 |
ZOLMITRIPTAN |
PADAGIS ISRAEL |
|
Approval |
09/30/2021 |
CARBAMAZEPINE ANDA #212948 |
ORIG-1 |
CARBAMAZEPINE |
ANBISON LAB |
|
Approval |