03/01/2021 |
XANAX NDA #018276 |
SUPPL-55 |
ALPRAZOLAM |
UPJOHN |
Labeling |
Approval |
03/01/2021 |
PLAVIX NDA #020839 |
SUPPL-74 |
CLOPIDOGREL BISULFATE |
SANOFI AVENTIS US |
Labeling |
Approval |
03/01/2021 |
XANAX XR NDA #021434 |
SUPPL-18 |
ALPRAZOLAM |
UPJOHN |
Labeling |
Approval |
03/01/2021 |
BUPROPION HYDROCHLORIDE ANDA #203969 |
SUPPL-2 |
BUPROPION HYDROCHLORIDE |
TORRENT |
Labeling |
Approval |
03/01/2021 |
BUPROPION HYDROCHLORIDE ANDA #203969 |
SUPPL-4 |
BUPROPION HYDROCHLORIDE |
TORRENT |
Labeling |
Approval |
03/01/2021 |
FLUDEOXYGLUCOSE F18 ANDA #204463 |
SUPPL-1 |
FLUDEOXYGLUCOSE F-18 |
DECATUR |
Labeling |
Approval |
03/01/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #204597 |
SUPPL-11 |
FLUOXETINE HYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
03/01/2021 |
TRIUMEQ NDA #205551 |
SUPPL-25 |
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
03/01/2021 |
FIRDAPSE NDA #208078 |
SUPPL-7 |
AMIFAMPRIDINE PHOSPHATE |
CATALYST PHARMS |
Labeling |
Approval |
03/01/2021 |
HYDROCODONE BITARTRATE ANDA #208269 |
ORIG-1 |
HYDROCODONE BITARTRATE |
ALVOGEN PINE BROOK |
|
Approval |
03/01/2021 |
DEFERASIROX ANDA #210945 |
SUPPL-2 |
DEFERASIROX |
MSN |
Manufacturing (CMC) |
Approval |
03/01/2021 |
DEFERASIROX ANDA #210945 |
SUPPL-3 |
DEFERASIROX |
MSN |
Labeling |
Approval |
03/01/2021 |
DEFERASIROX ANDA #210945 |
SUPPL-5 |
DEFERASIROX |
MSN |
Labeling |
Approval |
03/01/2021 |
IBRUTINIB ANDA #211350 |
ORIG-1 |
IBRUTINIB |
TEVA PHARMS USA INC |
|
Tentative Approval |
03/01/2021 |
LEVORPHANOL TARTRATE ANDA #211484 |
SUPPL-2 |
LEVORPHANOL TARTRATE |
VIRTUS PHARMS |
Labeling |
Approval |
03/01/2021 |
DOXEPIN HYDROCHLORIDE ANDA #211618 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
LEADING PHARMA LLC |
|
Approval |
03/01/2021 |
DOVATO NDA #211994 |
SUPPL-10 |
DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
03/01/2021 |
FLUPHENAZINE HYDROCHLORIDE ANDA #214674 |
ORIG-1 |
FLUPHENAZINE HYDROCHLORIDE |
NOVITIUM PHARMA |
|
Approval |
03/02/2021 |
H.P. ACTHAR GEL NDA #008372 |
SUPPL-68 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
03/02/2021 |
LOZOL NDA #018538 |
SUPPL-30 |
INDAPAMIDE |
SANOFI AVENTIS US |
Labeling |
Approval |
03/02/2021 |
ZIAC NDA #020186 |
SUPPL-37 |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TEVA BRANDED PHARM |
Labeling |
Approval |
03/02/2021 |
ZEMPLAR NDA #020819 |
SUPPL-36 |
PARICALCITOL |
ABBVIE |
Labeling |
Approval |
03/02/2021 |
CHILDREN'S CLARITIN NDA #021891 |
SUPPL-37 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
03/02/2021 |
CLARITIN NDA #021891 |
SUPPL-37 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
03/02/2021 |
SPIRONOLACTONE ANDA #205936 |
SUPPL-2 |
SPIRONOLACTONE |
ZYDUS PHARMS |
Labeling |
Approval |
03/02/2021 |
AZSTARYS NDA #212994 |
ORIG-1 |
SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE |
COMMCAVE THERAPEUTICS SA |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Approval |
03/03/2021 |
BUSPIRONE HYDROCHLORIDE ANDA #075521 |
SUPPL-10 |
BUSPIRONE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
03/03/2021 |
CARBAMAZEPINE ANDA #075712 |
SUPPL-29 |
CARBAMAZEPINE |
TORRENT PHARMS |
Labeling |
Approval |
03/03/2021 |
CARBAMAZEPINE ANDA #075712 |
SUPPL-32 |
CARBAMAZEPINE |
TORRENT PHARMS |
Labeling |
Approval |
03/03/2021 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #205151 |
ORIG-1 |
VALGANCICLOVIR HYDROCHLORIDE |
MYLAN |
|
Approval |
03/03/2021 |
HYDROMORPHONE HYDROCHLORIDE ANDA #205629 |
SUPPL-7 |
HYDROMORPHONE HYDROCHLORIDE |
OSMOTICA |
Labeling |
Approval |
03/03/2021 |
HYDROMORPHONE HYDROCHLORIDE ANDA #205629 |
SUPPL-11 |
HYDROMORPHONE HYDROCHLORIDE |
OSMOTICA |
Labeling |
Approval |
03/03/2021 |
ZEJULA NDA #208447 |
SUPPL-19 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
03/03/2021 |
ZEJULA NDA #208447 |
SUPPL-20 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
03/03/2021 |
OXALIPLATIN ANDA #208523 |
SUPPL-1 |
OXALIPLATIN |
CIPLA |
Labeling |
Approval |
03/03/2021 |
LORBRENA NDA #210868 |
SUPPL-4 |
LORLATINIB |
PFIZER |
Efficacy |
Approval |
03/03/2021 |
METHADONE HYDROCHLORIDE ANDA #212094 |
ORIG-1 |
METHADONE HYDROCHLORIDE |
LANNETT CO INC |
|
Approval |
03/03/2021 |
FOSAPREPITANT DIMEGLUMINE ANDA #212143 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
CHIA TAI TIANQING |
|
Approval |
03/03/2021 |
TESTOSTERONE ANDA #213922 |
ORIG-1 |
TESTOSTERONE |
ALEOR DERMACEUTICALS |
|
Approval |
03/03/2021 |
GUANFACINE HYDROCHLORIDE ANDA #214689 |
ORIG-1 |
GUANFACINE HYDROCHLORIDE |
UNICHEM |
|
Approval |
03/04/2021 |
DEMEROL NDA #005010 |
SUPPL-59 |
MEPERIDINE HYDROCHLORIDE |
VALIDUS PHARMS |
Labeling |
Approval |
03/04/2021 |
MS CONTIN NDA #019516 |
SUPPL-57 |
MORPHINE SULFATE |
PURDUE PHARMA LP |
Labeling |
Approval |
03/04/2021 |
DURAGESIC-100 NDA #019813 |
SUPPL-81 |
FENTANYL |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
DURAGESIC-12 NDA #019813 |
SUPPL-81 |
FENTANYL |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
DURAGESIC-25 NDA #019813 |
SUPPL-81 |
FENTANYL |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
DURAGESIC-37 NDA #019813 |
SUPPL-81 |
FENTANYL |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
DURAGESIC-50 NDA #019813 |
SUPPL-81 |
FENTANYL |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
DURAGESIC-75 NDA #019813 |
SUPPL-81 |
FENTANYL |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
DILAUDID NDA #019891 |
SUPPL-29 |
HYDROMORPHONE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
03/04/2021 |
DILAUDID NDA #019892 |
SUPPL-37 |
HYDROMORPHONE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
03/04/2021 |
FIORICET W/ CODEINE NDA #020232 |
SUPPL-45 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
ACTAVIS LABS UT INC |
Labeling |
Approval |
03/04/2021 |
ULTRAM NDA #020281 |
SUPPL-48 |
TRAMADOL HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
KADIAN NDA #020616 |
SUPPL-65 |
MORPHINE SULFATE |
ALLERGAN |
Labeling |
Approval |
03/04/2021 |
SUBUTEX NDA #020732 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE |
INDIVIOR INC |
Labeling |
Approval |
03/04/2021 |
SUBOXONE NDA #020733 |
SUPPL-28 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR INC |
Labeling |
Approval |
03/04/2021 |
ACTIQ NDA #020747 |
SUPPL-53 |
FENTANYL CITRATE |
CEPHALON |
Labeling |
Approval |
03/04/2021 |
ROXICODONE NDA #021011 |
SUPPL-11 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
03/04/2021 |
ULTRACET NDA #021123 |
SUPPL-20 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
03/04/2021 |
BUTRANS NDA #021306 |
SUPPL-37 |
BUPRENORPHINE |
PURDUE PHARMA LP |
Labeling |
Approval |
03/04/2021 |
SYMBYAX NDA #021520 |
SUPPL-52 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
LILLY |
Labeling |
Approval |
03/04/2021 |
OPANA ER NDA #021610 |
SUPPL-28 |
OXYMORPHONE HYDROCHLORIDE |
ENDO PHARMS |
Labeling |
Approval |
03/04/2021 |
PATANASE NDA #021861 |
SUPPL-15 |
OLOPATADINE HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
03/04/2021 |
VIVITROL NDA #021897 |
SUPPL-52 |
NALTREXONE |
ALKERMES |
Labeling |
Approval |
03/04/2021 |
FENTORA NDA #021947 |
SUPPL-34 |
FENTANYL CITRATE |
CEPHALON |
Labeling |
Approval |
03/04/2021 |
MORPHINE SULFATE NDA #022195 |
SUPPL-19 |
MORPHINE SULFATE |
HIKMA |
Labeling |
Approval |
03/04/2021 |
MORPHINE SULFATE NDA #022207 |
SUPPL-10 |
MORPHINE SULFATE |
HIKMA |
Labeling |
Approval |
03/04/2021 |
ONSOLIS NDA #022266 |
SUPPL-25 |
FENTANYL CITRATE |
BDSI |
Labeling |
Approval |
03/04/2021 |
OXYCONTIN NDA #022272 |
SUPPL-46 |
OXYCODONE HYDROCHLORIDE |
PURDUE PHARMA LP |
Labeling |
Approval |
03/04/2021 |
NUCYNTA NDA #022304 |
SUPPL-23 |
TAPENTADOL HYDROCHLORIDE |
COLLEGIUM PHARM INC |
Labeling |
Approval |
03/04/2021 |
CONZIP NDA #022370 |
SUPPL-20 |
TRAMADOL HYDROCHLORIDE |
CIPHER PHARMS INC |
Labeling |
Approval |
03/04/2021 |
CODEINE SULFATE NDA #022402 |
SUPPL-14 |
CODEINE SULFATE |
HIKMA |
Labeling |
Approval |
03/04/2021 |
SUBOXONE NDA #022410 |
SUPPL-42 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR INC |
Labeling |
Approval |
03/04/2021 |
LAZANDA NDA #022569 |
SUPPL-30 |
FENTANYL CITRATE |
BTCP PHARMA |
Labeling |
Approval |
03/04/2021 |
NUCYNTA ER NDA #200533 |
SUPPL-23 |
TAPENTADOL HYDROCHLORIDE |
COLLEGIUM PHARM INC |
Labeling |
Approval |
03/04/2021 |
OXYCODONE HYDROCHLORIDE NDA #200534 |
SUPPL-11 |
OXYCODONE HYDROCHLORIDE |
GENUS LIFESCIENCES |
Labeling |
Approval |
03/04/2021 |
OXYCODONE HYDROCHLORIDE NDA #200535 |
SUPPL-19 |
OXYCODONE HYDROCHLORIDE |
GENUS LIFESCIENCES |
Labeling |
Approval |
03/04/2021 |
OXYCODONE HYDROCHLORIDE NDA #201194 |
SUPPL-10 |
OXYCODONE HYDROCHLORIDE |
VISTAPHARM |
Labeling |
Approval |
03/04/2021 |
MORPHINE SULFATE NDA #201517 |
SUPPL-17 |
MORPHINE SULFATE |
LANNETT CO INC |
Labeling |
Approval |
03/04/2021 |
OXAYDO NDA #202080 |
SUPPL-12 |
OXYCODONE HYDROCHLORIDE |
ZYLA |
Labeling |
Approval |
03/04/2021 |
CODEINE SULFATE NDA #202245 |
SUPPL-9 |
CODEINE SULFATE |
HIKMA |
Labeling |
Approval |
03/04/2021 |
SUBSYS NDA #202788 |
SUPPL-23 |
FENTANYL |
BTCP PHARMA |
Labeling |
Approval |
03/04/2021 |
ZOHYDRO ER NDA #202880 |
SUPPL-20 |
HYDROCODONE BITARTRATE |
PERSION |
Labeling |
Approval |
03/04/2021 |
NUCYNTA NDA #203794 |
SUPPL-9 |
TAPENTADOL HYDROCHLORIDE |
COLLEGIUM PHARM INC |
Labeling |
Approval |
03/04/2021 |
ZUBSOLV NDA #204242 |
SUPPL-19 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
OREXO US INC |
Labeling |
Approval |
03/04/2021 |
PROBUPHINE NDA #204442 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE |
TITAN PHARMS |
Labeling |
Approval |
03/04/2021 |
BUNAVAIL NDA #205637 |
SUPPL-21 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
BDSI |
Labeling |
Approval |
03/04/2021 |
HYSINGLA ER NDA #206627 |
SUPPL-12 |
HYDROCODONE BITARTRATE |
PURDUE PHARMA LP |
Labeling |
Approval |
03/04/2021 |
GENVOYA NDA #207561 |
SUPPL-25 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
03/04/2021 |
BELBUCA NDA #207932 |
SUPPL-15 |
BUPRENORPHINE HYDROCHLORIDE |
BDSI |
Labeling |
Approval |
03/04/2021 |
CASSIPA NDA #208042 |
SUPPL-4 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
03/04/2021 |
XTAMPZA ER NDA #208090 |
SUPPL-15 |
OXYCODONE |
COLLEGIUM PHARM INC |
Labeling |
Approval |
03/04/2021 |
DESCOVY NDA #208215 |
SUPPL-17 |
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
03/04/2021 |
ODEFSEY NDA #208351 |
SUPPL-11 |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
03/04/2021 |
VEMLIDY NDA #208464 |
SUPPL-12 |
TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
03/04/2021 |
APADAZ NDA #208653 |
SUPPL-7 |
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE |
KVK TECH INC |
Labeling |
Approval |
03/04/2021 |
ROXYBOND NDA #209777 |
SUPPL-7 |
OXYCODONE HYDROCHLORIDE |
OHEMO LIFE |
Labeling |
Approval |
03/04/2021 |
SUBLOCADE NDA #209819 |
SUPPL-17 |
BUPRENORPHINE |
INDIVIOR INC |
Labeling |
Approval |
03/04/2021 |
SUBLOCADE NDA #209819 |
SUPPL-18 |
BUPRENORPHINE |
INDIVIOR INC |
Labeling |
Approval |
03/04/2021 |
BIKTARVY NDA #210251 |
SUPPL-10 |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
03/04/2021 |
OLINVYK NDA #210730 |
SUPPL-1 |
OLICERIDINE |
TREVENA |
Labeling |
Approval |