| 05/02/2022 |
METHOTREXATE LPF
NDA #011719 |
SUPPL-135 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 05/02/2022 |
METHOTREXATE PRESERVATIVE FREE
NDA #011719 |
SUPPL-135 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 05/02/2022 |
METHOTREXATE SODIUM
NDA #011719 |
SUPPL-135 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 05/02/2022 |
METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719 |
SUPPL-135 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 05/02/2022 |
NIASPAN
NDA #020381 |
SUPPL-55 |
NIACIN |
ABBVIE |
Labeling |
Approval |
| 05/02/2022 |
NIASPAN TITRATION STARTER PACK
NDA #020381 |
SUPPL-55 |
NIACIN |
ABBVIE |
Labeling |
Approval |
| 05/02/2022 |
EMEND
NDA #022023 |
SUPPL-21 |
FOSAPREPITANT DIMEGLUMINE |
MERCK AND CO INC |
Efficacy |
Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #205533 |
ORIG-1 |
BORTEZOMIB |
APOTEX |
|
Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #205857 |
ORIG-1 |
BORTEZOMIB |
TEVA PHARMS USA |
|
Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #208392 |
ORIG-1 |
BORTEZOMIB |
PHARMASCIENCE INC |
|
Approval |
| 05/02/2022 |
BORTEZOMIB
NDA #209191 |
ORIG-1 |
BORTEZOMIB |
HOSPIRA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 05/02/2022 |
METHYLNALTREXONE BROMIDE
ANDA #209615 |
ORIG-1 |
METHYLNALTREXONE BROMIDE |
ACTAVIS LABS FL INC |
|
Tentative Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #209659 |
ORIG-1 |
BORTEZOMIB |
FRESENIUS KABI USA |
|
Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #210204 |
ORIG-1 |
BORTEZOMIB |
ZYDUS PHARMS |
|
Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #210824 |
ORIG-1 |
BORTEZOMIB |
QILU PHARM HAINAN |
|
Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #212825 |
ORIG-1 |
BORTEZOMIB |
EUGIA PHARMA |
|
Approval |
| 05/02/2022 |
BORTEZOMIB
ANDA #213823 |
ORIG-1 |
BORTEZOMIB |
BAXTER HLTHCARE CORP |
|
Approval |
| 05/02/2022 |
OSELTAMIVIR PHOSPHATE
ANDA #215313 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
MSN |
|
Approval |
| 05/03/2022 |
PLAQUENIL
NDA #009768 |
SUPPL-56 |
HYDROXYCHLOROQUINE SULFATE |
CONCORDIA |
Labeling |
Approval |
| 05/03/2022 |
INTRALIPID 10%
NDA #017643 |
SUPPL-82 |
SOYBEAN OIL |
FRESENIUS |
Labeling |
Approval |
| 05/03/2022 |
LOPRESSOR HCT
NDA #018303 |
SUPPL-40 |
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
VALIDUS PHARMS |
Labeling |
Approval |
| 05/03/2022 |
INTRALIPID 20%
NDA #018449 |
SUPPL-49 |
SOYBEAN OIL |
FRESENIUS |
Labeling |
Approval |
| 05/03/2022 |
INTRALIPID 30%
NDA #019942 |
SUPPL-20 |
SOYBEAN OIL |
FRESENIUS |
Labeling |
Approval |
| 05/03/2022 |
INTRALIPID 20%
NDA #020248 |
SUPPL-26 |
SOYBEAN OIL |
FRESENIUS |
Labeling |
Approval |
| 05/03/2022 |
SUBUTEX
NDA #020732 |
SUPPL-26 |
BUPRENORPHINE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
| 05/03/2022 |
SUBOXONE
NDA #020733 |
SUPPL-30 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
| 05/03/2022 |
SUBOXONE
NDA #022410 |
SUPPL-45 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #040516 |
SUPPL-14 |
CHLOROQUINE PHOSPHATE |
IMPAX LABS |
Labeling |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #078633 |
SUPPL-27 |
BUPRENORPHINE HYDROCHLORIDE |
HIKMA |
REMS |
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #080880 |
SUPPL-66 |
CHLOROQUINE PHOSPHATE |
IMPAX LABS |
Labeling |
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #083082 |
SUPPL-58 |
CHLOROQUINE PHOSPHATE |
HIKMA PHARMS |
Labeling |
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #090249 |
SUPPL-7 |
CHLOROQUINE PHOSPHATE |
IPCA LABS LTD |
Labeling |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090279 |
SUPPL-14 |
BUPRENORPHINE HYDROCHLORIDE |
RUBICON |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090360 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE |
BARR |
REMS |
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #090610 |
SUPPL-9 |
CHLOROQUINE PHOSPHATE |
IPCA LABS LTD |
Labeling |
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #090612 |
SUPPL-5 |
CHLOROQUINE PHOSPHATE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090622 |
SUPPL-35 |
BUPRENORPHINE HYDROCHLORIDE |
ETHYPHARM |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090819 |
SUPPL-25 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
REMS |
Approval |
| 05/03/2022 |
PREGABALIN
ANDA #091040 |
ORIG-1 |
PREGABALIN |
LUPIN LTD |
|
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149 |
SUPPL-19 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422 |
SUPPL-44 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
REMS |
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #091621 |
SUPPL-5 |
CHLOROQUINE PHOSPHATE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201066 |
SUPPL-17 |
BUPRENORPHINE HYDROCHLORIDE |
MYLAN |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633 |
SUPPL-21 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SUN PHARM |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201760 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
REMS |
Approval |
| 05/03/2022 |
DEXLANSOPRAZOLE
ANDA #202294 |
SUPPL-2 |
DEXLANSOPRAZOLE |
ENDO OPERATIONS |
Labeling |
Approval |
| 05/03/2022 |
DEXLANSOPRAZOLE
ANDA #202294 |
SUPPL-3 |
DEXLANSOPRAZOLE |
ENDO OPERATIONS |
Labeling |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136 |
SUPPL-38 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
AMNEAL PHARMS |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203326 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
HIKMA |
REMS |
Approval |
| 05/03/2022 |
ZUBSOLV
NDA #204242 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
OREXO US INC |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431 |
SUPPL-25 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ETHYPHARM USA CORP |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022 |
SUPPL-13 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
LANNETT CO INC |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205299 |
SUPPL-9 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205601 |
SUPPL-8 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
RHODES PHARMS |
REMS |
Approval |
| 05/03/2022 |
BUNAVAIL
NDA #205637 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
BDSI |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205806 |
SUPPL-9 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205954 |
SUPPL-19 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ALVOGEN |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #206953 |
SUPPL-9 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #207276 |
SUPPL-12 |
BUPRENORPHINE HYDROCHLORIDE |
RHODES PHARMS |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607 |
SUPPL-12 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
MYLAN TECHNOLOGIES |
REMS |
Approval |
| 05/03/2022 |
CASSIPA
NDA #208042 |
SUPPL-6 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
REMS |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #209069 |
SUPPL-6 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
WES PHARMA INC |
REMS |
Approval |
| 05/03/2022 |
ZILEUTON
ANDA #211043 |
ORIG-1 |
ZILEUTON |
TEVA PHARMS USA |
|
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #211785 |
SUPPL-2 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
MYLAN TECHNOLOGIES |
REMS |
Approval |
| 05/03/2022 |
LACOSAMIDE
ANDA #214677 |
ORIG-1 |
LACOSAMIDE |
FRESENIUS KABI USA |
|
Approval |
| 05/03/2022 |
CHLOROQUINE PHOSPHATE
ANDA #214756 |
SUPPL-2 |
CHLOROQUINE PHOSPHATE |
SUVEN PHARMS |
Labeling |
Approval |
| 05/03/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #214930 |
SUPPL-2 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ALKEM LABS LTD |
REMS |
Approval |
| 05/03/2022 |
VOQUEZNA TRIPLE PAK
NDA #215152 |
ORIG-1 |
AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE |
PHATHOM |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Approval |
| 05/03/2022 |
VOQUEZNA DUAL PAK
NDA #215153 |
ORIG-1 |
AMOXICILLIN; VONOPRAZAN FUMARATE |
PHATHOM |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 05/03/2022 |
DOCOSANOL
ANDA #215839 |
ORIG-1 |
DOCOSANOL |
ALEMBIC |
|
Approval |
| 05/03/2022 |
ZINC SULFATE
ANDA #216249 |
ORIG-1 |
ZINC SULFATE |
GLAND PHARMA LTD |
|
Approval |
| 05/04/2022 |
OPTIRAY 160
NDA #019710 |
SUPPL-64 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 05/04/2022 |
OPTIRAY 240
NDA #019710 |
SUPPL-64 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 05/04/2022 |
OPTIRAY 300
NDA #019710 |
SUPPL-64 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 05/04/2022 |
OPTIRAY 320
NDA #019710 |
SUPPL-64 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 05/04/2022 |
OPTIRAY 350
NDA #019710 |
SUPPL-64 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 05/04/2022 |
TALTZ
BLA #125521 |
SUPPL-23 |
IXEKIZUMAB |
ELI LILLY AND CO |
|
Approval |
| 05/04/2022 |
AUSTEDO
NDA #208082 |
SUPPL-11 |
DEUTETRABENAZINE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 05/04/2022 |
KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935 |
SUPPL-19 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
| 05/04/2022 |
POMALIDOMIDE
ANDA #209956 |
ORIG-1 |
POMALIDOMIDE |
TEVA PHARMS USA |
|
Approval |
| 05/04/2022 |
PIQRAY
NDA #212526 |
SUPPL-6 |
ALPELISIB |
NOVARTIS |
Labeling |
Approval |
| 05/04/2022 |
NEOSTIGMINE METHYLSULFATE
ANDA #212968 |
SUPPL-1 |
NEOSTIGMINE METHYLSULFATE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 05/04/2022 |
TAMSULOSIN HYDROCHLORIDE
ANDA #214730 |
ORIG-1 |
TAMSULOSIN HYDROCHLORIDE |
ASCENT PHARMS INC |
|
Approval |
| 05/04/2022 |
ENHERTU
BLA #761139 |
SUPPL-17 |
FAM-TRASTUZUMAB DERUXTECAN-NXKI |
DAIICHI SANKYO |
|
Approval |
| 05/04/2022 |
ENHERTU
BLA #761139 |
SUPPL-20 |
FAM-TRASTUZUMAB DERUXTECAN-NXKI |
DAIICHI SANKYO |
|
Approval |
| 05/05/2022 |
APOKYN
NDA #021264 |
SUPPL-22 |
APOMORPHINE HYDROCHLORIDE |
MDD US |
Labeling |
Approval |
| 05/05/2022 |
FINASTERIDE
ANDA #077335 |
SUPPL-1 |
FINASTERIDE |
CIPLA |
Labeling |
Approval |
| 05/05/2022 |
FINASTERIDE
ANDA #090060 |
SUPPL-4 |
FINASTERIDE |
HETERO LABS LTD III |
Labeling |
Approval |
| 05/05/2022 |
LEUKINE
BLA #103362 |
SUPPL-5249 |
SARGRAMOSTIM |
BERLEX LABS |
|
Approval |
| 05/05/2022 |
ALOSETRON HYDROCHLORIDE
ANDA #200652 |
SUPPL-8 |
ALOSETRON HYDROCHLORIDE |
HIKMA |
REMS |
Approval |
| 05/05/2022 |
CLOPIDOGREL BISULFATE
ANDA #203751 |
SUPPL-8 |
CLOPIDOGREL BISULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 05/05/2022 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203855 |
SUPPL-8 |
PRAMIPEXOLE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 05/05/2022 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203855 |
SUPPL-10 |
PRAMIPEXOLE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 05/05/2022 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203855 |
SUPPL-14 |
PRAMIPEXOLE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 05/05/2022 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203855 |
SUPPL-15 |
PRAMIPEXOLE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 05/05/2022 |
ALOSETRON HYDROCHLORIDE
ANDA #206113 |
SUPPL-5 |
ALOSETRON HYDROCHLORIDE |
ENDO OPERATIONS |
REMS |
Approval |
| 05/05/2022 |
ALOSETRON HYDROCHLORIDE
ANDA #206647 |
SUPPL-12 |
ALOSETRON HYDROCHLORIDE |
AMNEAL PHARMS |
REMS |
Approval |
| 05/05/2022 |
ILOPERIDONE
ANDA #206890 |
ORIG-1 |
ILOPERIDONE |
LUPIN LTD |
|
Approval |
| 05/05/2022 |
ALOSETRON HYDROCHLORIDE
ANDA #209180 |
SUPPL-5 |
ALOSETRON HYDROCHLORIDE |
RISING |
REMS |
Approval |
| 05/05/2022 |
LUBIPROSTONE
ANDA #209450 |
SUPPL-2 |
LUBIPROSTONE |
AMNEAL |
Manufacturing (CMC) |
Approval |
| 05/05/2022 |
NEOSTIGMINE METHYLSULFATE
ANDA #210051 |
SUPPL-4 |
NEOSTIGMINE METHYLSULFATE |
AMNEAL |
Labeling |
Approval |
| 05/05/2022 |
KYNMOBI
NDA #210875 |
SUPPL-7 |
APOMORPHINE HYDROCHLORIDE |
SUMITOMO PHARMA AM |
Labeling |
Approval |
| 05/05/2022 |
RAMELTEON
ANDA #212650 |
SUPPL-2 |
RAMELTEON |
I3 PHARMS |
Labeling |
Approval |
| 05/05/2022 |
RANOLAZINE
ANDA #212788 |
ORIG-1 |
RANOLAZINE |
HETERO LABS LTD III |
|
Approval |
| 05/05/2022 |
POTASSIUM CITRATE
ANDA #212799 |
SUPPL-4 |
POTASSIUM CITRATE |
BIONPHARMA |
Labeling |
Approval |
| 05/05/2022 |
ALOSETRON HYDROCHLORIDE
ANDA #213614 |
SUPPL-13 |
ALOSETRON HYDROCHLORIDE |
MANKIND PHARMA |
REMS |
Approval |
| 05/05/2022 |
DROXIDOPA
ANDA #214217 |
ORIG-1 |
DROXIDOPA |
CHARTWELL RX |
|
Approval |
| 05/05/2022 |
LIDOCAINE HYDROCHLORIDE
ANDA #214269 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
SINTETICA US |
|
Approval |
| 05/05/2022 |
DILTIAZEM HYDROCHLORIDE
ANDA #215775 |
ORIG-1 |
DILTIAZEM HYDROCHLORIDE |
DR REDDYS LABS SA |
|
Approval |
| 05/06/2022 |
DOXIL (LIPOSOMAL)
NDA #050718 |
SUPPL-60 |
DOXORUBICIN HYDROCHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 05/06/2022 |
DICLOFENAC SODIUM
ANDA #207714 |
ORIG-1 |
DICLOFENAC SODIUM |
APOTEX |
|
Approval |
| 05/06/2022 |
MESALAMINE
ANDA #209970 |
ORIG-1 |
MESALAMINE |
TEVA PHARMS USA |
|
Approval |
| 05/09/2022 |
D.H.E. 45
NDA #005929 |
SUPPL-45 |
DIHYDROERGOTAMINE MESYLATE |
BAUSCH |
Labeling |
Approval |
| 05/09/2022 |
MIGRANAL
NDA #020148 |
SUPPL-26 |
DIHYDROERGOTAMINE MESYLATE |
BAUSCH |
Labeling |
Approval |
| 05/09/2022 |
LEVULAN
NDA #020965 |
SUPPL-17 |
AMINOLEVULINIC ACID HYDROCHLORIDE |
DUSA |
Labeling |
Approval |
| 05/09/2022 |
BRILINTA
NDA #022433 |
SUPPL-34 |
TICAGRELOR |
ASTRAZENECA |
Efficacy |
Approval |
| 05/09/2022 |
VORICONAZOLE
ANDA #214516 |
ORIG-1 |
VORICONAZOLE |
MEITHEAL |
|
Approval |
| 05/10/2022 |
RITONAVIR
ANDA #203759 |
ORIG-1 |
RITONAVIR |
CIPLA |
|
Approval |
| 05/10/2022 |
LEVOTHYROXINE SODIUM
ANDA #207588 |
ORIG-1 |
LEVOTHYROXINE SODIUM |
WATSON LABS TEVA |
|
Approval |
| 05/10/2022 |
OLUMIANT
NDA #207924 |
SUPPL-6 |
BARICITINIB |
ELI LILLY AND CO |
Efficacy |
Approval |
| 05/10/2022 |
ROFLUMILAST
ANDA #208299 |
ORIG-1 |
ROFLUMILAST |
PRINSTON INC |
|
Approval |
| 05/10/2022 |
IBUPROFEN
ANDA #210149 |
SUPPL-4 |
IBUPROFEN |
GUARDIAN DRUG |
Manufacturing (CMC) |
Approval |
| 05/10/2022 |
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #211965 |
SUPPL-1 |
MAGNESIUM SULFATE |
BAXTER HLTHCARE CORP |
Manufacturing (CMC) |
Approval |
| 05/10/2022 |
MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #211966 |
SUPPL-1 |
MAGNESIUM SULFATE |
BAXTER HLTHCARE CORP |
Manufacturing (CMC) |
Approval |
| 05/10/2022 |
POSACONAZOLE
ANDA #212226 |
ORIG-1 |
POSACONAZOLE |
SPECGX LLC |
|
Approval |
| 05/10/2022 |
NEOSTIGMINE METHYLSULFATE
ANDA #212512 |
SUPPL-1 |
NEOSTIGMINE METHYLSULFATE |
BE PHARMS |
Labeling |
Approval |
| 05/10/2022 |
SUGAMMADEX
ANDA #214319 |
ORIG-1 |
SUGAMMADEX |
SUN PHARM INDS |
|
Tentative Approval |
| 05/10/2022 |
ARFORMOTEROL TARTRATE
ANDA #214779 |
ORIG-1 |
ARFORMOTEROL TARTRATE |
ALEMBIC |
|
Approval |
| 05/10/2022 |
VIGABATRIN
ANDA #215601 |
ORIG-1 |
VIGABATRIN |
AUROBINDO PHARMA LTD |
|
Approval |
| 05/11/2022 |
YERVOY
BLA #125377 |
SUPPL-124 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/11/2022 |
OPDIVO
BLA #125554 |
SUPPL-108 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/11/2022 |
ROPINIROLE HYDROCHLORIDE
ANDA #204413 |
ORIG-1 |
ROPINIROLE HYDROCHLORIDE |
PRINSTON INC |
|
Approval |
| 05/11/2022 |
IMBRUVICA
NDA #205552 |
SUPPL-35 |
IBRUTINIB |
PHARMACYCLICS LLC |
Labeling |
Approval |
| 05/11/2022 |
TRELEGY ELLIPTA
NDA #209482 |
SUPPL-13 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 05/11/2022 |
IMBRUVICA
NDA #210563 |
SUPPL-11 |
IBRUTINIB |
PHARMACYCLICS LLC |
Labeling |
Approval |
| 05/11/2022 |
ESOMEPRAZOLE MAGNESIUM
NDA #214278 |
SUPPL-2 |
ESOMEPRAZOLE MAGNESIUM |
DEXCEL |
Labeling |
Approval |
| 05/11/2022 |
MESALAMINE
ANDA #214585 |
ORIG-1 |
MESALAMINE |
SUN PHARM |
|
Approval |
| 05/11/2022 |
DICLOFENAC POTASSIUM
ANDA #215750 |
ORIG-1 |
DICLOFENAC POTASSIUM |
UMEDICA |
|
Approval |
| 05/11/2022 |
IMFINZI
BLA #761069 |
SUPPL-32 |
DURVALUMAB |
ASTRAZENECA UK LTD |
|
Approval |
| 05/12/2022 |
LUMIZYME
BLA #125291 |
SUPPL-156 |
ALGLUCOSIDASE ALFA |
GENZYME |
|
Approval |
| 05/12/2022 |
LUMIZYME
BLA #125291 |
SUPPL-157 |
ALGLUCOSIDASE ALFA |
GENZYME |
|
Approval |
| 05/12/2022 |
NINTEDANIB
ANDA #215123 |
ORIG-1 |
NINTEDANIB |
EUGIA PHARMA SPECLTS |
|
Tentative Approval |
| 05/12/2022 |
RADICAVA ORS
NDA #215446 |
ORIG-1 |
EDARAVONE |
MITSUBISHI TANABE |
Type 3 - New Dosage Form |
Approval |
| 05/13/2022 |
DIAMOX
NDA #008943 |
SUPPL-52 |
ACETAZOLAMIDE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 05/13/2022 |
DIAMOX
NDA #009388 |
SUPPL-38 |
ACETAZOLAMIDE SODIUM |
TEVA WOMENS |
Labeling |
Approval |
| 05/13/2022 |
DIAMOX
NDA #012945 |
SUPPL-47 |
ACETAZOLAMIDE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 05/13/2022 |
NIZORAL ANTI-DANDRUFF
NDA #020310 |
SUPPL-27 |
KETOCONAZOLE |
KRAMER |
Manufacturing (CMC) |
Approval |
| 05/13/2022 |
VALGANCICLOVIR HYDROCHLORIDE
ANDA #206876 |
SUPPL-2 |
VALGANCICLOVIR HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 05/13/2022 |
VALGANCICLOVIR HYDROCHLORIDE
ANDA #206876 |
SUPPL-3 |
VALGANCICLOVIR HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 05/13/2022 |
NICOTINE POLACRILEX
ANDA #215357 |
ORIG-1 |
NICOTINE POLACRILEX |
AUROBINDO PHARMA LTD |
|
Approval |
| 05/13/2022 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #215798 |
ORIG-1 |
SAPROPTERIN DIHYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 05/13/2022 |
MOUNJARO
NDA #215866 |
ORIG-1 |
TIRZEPATIDE |
ELI LILLY AND CO |
Type 1 - New Molecular Entity |
Approval |
| 05/13/2022 |
MOUNJARO (AUTOINJECTOR)
NDA #215866 |
ORIG-1 |
TIRZEPATIDE |
ELI LILLY AND CO |
Type 1 - New Molecular Entity |
Approval |
| 05/13/2022 |
INMAZEB
BLA #761169 |
SUPPL-3 |
ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
| 05/16/2022 |
ESTRADIOL AND PROGESTERONE
ANDA #214293 |
ORIG-1 |
ESTRADIOL; PROGESTERONE |
AMNEAL PHARMS |
|
Approval |
| 05/16/2022 |
CARMUSTINE
NDA #215000 |
ORIG-1 |
CARMUSTINE |
ACCORD HLTHCARE |
Type 2 - New Active Ingredient |
Approval |
| 05/17/2022 |
DUODOTE
NDA #021983 |
SUPPL-38 |
ATROPINE; PRALIDOXIME CHLORIDE |
MMT |
Labeling |
Approval |
| 05/17/2022 |
CLEOCIN
NDA #050680 |
SUPPL-19 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 05/17/2022 |
CLEOCIN
NDA #050767 |
SUPPL-18 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 05/17/2022 |
MOXATAG
NDA #050813 |
SUPPL-9 |
AMOXICILLIN |
PRAGMA |
Labeling |
Approval |
| 05/17/2022 |
TECHNETIUM TC 99M SESTAMIBI
ANDA #078098 |
SUPPL-10 |
TECHNETIUM TC-99M SESTAMIBI KIT |
CURIUM |
Labeling |
Approval |
| 05/17/2022 |
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #079043 |
SUPPL-6 |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Manufacturing (CMC) |
Approval |
| 05/17/2022 |
BUPRENORPHINE
ANDA #207490 |
ORIG-1 |
BUPRENORPHINE |
ALVOGEN |
|
Approval |
| 05/17/2022 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #209452 |
SUPPL-1 |
SAPROPTERIN DIHYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 05/18/2022 |
FINASTERIDE
ANDA #078341 |
SUPPL-17 |
FINASTERIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/18/2022 |
FINASTERIDE
ANDA #078341 |
SUPPL-21 |
FINASTERIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/18/2022 |
FINASTERIDE
ANDA #078341 |
SUPPL-23 |
FINASTERIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/18/2022 |
FINASTERIDE
ANDA #078341 |
SUPPL-24 |
FINASTERIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/18/2022 |
GRANISETRON HYDROCHLORIDE
ANDA #078522 |
SUPPL-6 |
GRANISETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/18/2022 |
PANTOPRAZOLE SODIUM
ANDA #204400 |
ORIG-1 |
PANTOPRAZOLE SODIUM |
GLAND PHARMA LTD |
|
Approval |
| 05/18/2022 |
TADALAFIL
ANDA #206956 |
SUPPL-2 |
TADALAFIL |
RISING |
Labeling |
Approval |
| 05/18/2022 |
TADALAFIL
ANDA #206957 |
SUPPL-2 |
TADALAFIL |
MYLAN |
Labeling |
Approval |
| 05/18/2022 |
ABIRATERONE ACETATE
ANDA #208432 |
SUPPL-1 |
ABIRATERONE ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 05/18/2022 |
ABIRATERONE ACETATE
ANDA #208432 |
SUPPL-4 |
ABIRATERONE ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 05/18/2022 |
TPOXX
NDA #208627 |
SUPPL-7 |
TECOVIRIMAT |
SIGA TECHNOLOGIES |
Efficacy |
Approval |
| 05/18/2022 |
LINACLOTIDE
ANDA #209564 |
SUPPL-1 |
LINACLOTIDE |
MYLAN |
Labeling |
Approval |
| 05/18/2022 |
LINACLOTIDE
ANDA #209564 |
SUPPL-2 |
LINACLOTIDE |
MYLAN |
Labeling |
Approval |
| 05/18/2022 |
PERPHENAZINE
ANDA #210163 |
ORIG-1 |
PERPHENAZINE |
APPCO |
|
Approval |
| 05/18/2022 |
TADALAFIL
ANDA #210392 |
SUPPL-14 |
TADALAFIL |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 05/18/2022 |
CEFPODOXIME PROXETIL
ANDA #210568 |
ORIG-1 |
CEFPODOXIME PROXETIL |
ALKEM LABS LTD |
|
Approval |
| 05/18/2022 |
PIRFENIDONE
ANDA #212680 |
ORIG-1 |
PIRFENIDONE |
MICRO LABS |
|
Approval |
| 05/18/2022 |
PANTOPRAZOLE SODIUM
ANDA #213778 |
ORIG-1 |
PANTOPRAZOLE SODIUM |
ASPIRO |
|
Approval |
| 05/18/2022 |
TPOXX
NDA #214518 |
ORIG-1 |
TECOVIRIMAT |
SIGA TECHNOLOGIES |
Type 3 - New Dosage Form |
Approval |
| 05/18/2022 |
PANTOPRAZOLE SODIUM
ANDA #216171 |
ORIG-1 |
PANTOPRAZOLE SODIUM |
BE PHARMS |
|
Approval |
| 05/19/2022 |
ULTANE
NDA #020478 |
SUPPL-32 |
SEVOFLURANE |
ABBVIE |
Labeling |
Approval |
| 05/19/2022 |
VIMPAT
NDA #022253 |
SUPPL-54 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
| 05/19/2022 |
VIMPAT
NDA #022254 |
SUPPL-44 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
| 05/19/2022 |
VIMPAT
NDA #022255 |
SUPPL-36 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
| 05/19/2022 |
GRANISETRON HYDROCHLORIDE
ANDA #078090 |
SUPPL-6 |
GRANISETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/19/2022 |
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078096 |
SUPPL-6 |
GRANISETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/19/2022 |
PROLIA
BLA #125320 |
SUPPL-210 |
DENOSUMAB |
AMGEN |
|
Approval |
| 05/19/2022 |
XGEVA
BLA #125320 |
SUPPL-210 |
DENOSUMAB |
AMGEN |
|
Approval |
| 05/19/2022 |
ABIRATERONE ACETATE
ANDA #209227 |
SUPPL-4 |
ABIRATERONE ACETATE |
GLENMARK SPECLT |
Manufacturing (CMC) |
Approval |
| 05/19/2022 |
NEOSTIGMINE METHYLSULFATE
ANDA #209933 |
SUPPL-1 |
NEOSTIGMINE METHYLSULFATE |
AMPHASTAR PHARMS INC |
Labeling |
Approval |
| 05/19/2022 |
AMBRISENTAN
ANDA #210701 |
ORIG-1 |
AMBRISENTAN |
APOTEX |
|
Approval |
| 05/19/2022 |
IODIXANOL
ANDA #214271 |
ORIG-1 |
IODIXANOL |
HENGRUI PHARMA |
|
Approval |
| 05/19/2022 |
LACOSAMIDE
ANDA #214672 |
ORIG-1 |
LACOSAMIDE |
ALKEM LABS LTD |
|
Approval |
| 05/19/2022 |
PANTOPRAZOLE SODIUM
ANDA #214680 |
ORIG-1 |
PANTOPRAZOLE SODIUM |
KNACK |
|
Approval |
| 05/19/2022 |
EBANGA
BLA #761172 |
SUPPL-4 |
ANSUVIMAB-ZYKL |
RIDGEBACK BIOTHERAPEUTICS |
|
Approval |
| 05/20/2022 |
TYVASO
NDA #022387 |
SUPPL-20 |
TREPROSTINIL |
UNITED THERAP |
Labeling |
Approval |
| 05/20/2022 |
CLEOCIN HYDROCHLORIDE
NDA #050162 |
SUPPL-104 |
CLINDAMYCIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 05/20/2022 |
CLEOCIN PHOSPHATE
NDA #050441 |
SUPPL-85 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 05/20/2022 |
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639 |
SUPPL-42 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 05/20/2022 |
VIDAZA
NDA #050794 |
SUPPL-34 |
AZACITIDINE |
BRISTOL-MYERS |
Efficacy |
Approval |
| 05/20/2022 |
KEYTRUDA
BLA #125514 |
SUPPL-123 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 05/20/2022 |
APIXABAN
ANDA #210013 |
SUPPL-1 |
APIXABAN |
MICRO LABS |
Labeling |
Approval |
| 05/20/2022 |
APIXABAN
ANDA #210013 |
SUPPL-2 |
APIXABAN |
MICRO LABS |
Labeling |
Approval |
| 05/20/2022 |
APIXABAN
ANDA #210128 |
SUPPL-1 |
APIXABAN |
MYLAN |
Labeling |
Approval |
| 05/20/2022 |
APIXABAN
ANDA #210128 |
SUPPL-2 |
APIXABAN |
MYLAN |
Labeling |
Approval |
| 05/20/2022 |
APIXABAN
ANDA #210152 |
SUPPL-1 |
APIXABAN |
BIONPHARMA |
Labeling |
Approval |
| 05/20/2022 |
APIXABAN
ANDA #210152 |
SUPPL-2 |
APIXABAN |
BIONPHARMA |
Labeling |
Approval |
| 05/20/2022 |
PIRFENIDONE
ANDA #212708 |
ORIG-1 |
PIRFENIDONE |
ALEMBIC |
|
Approval |
| 05/20/2022 |
EXEMESTANE
ANDA #216454 |
ORIG-1 |
EXEMESTANE |
EUGIA PHARMA |
|
Approval |
| 05/20/2022 |
DUPIXENT
BLA #761055 |
SUPPL-40 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
| 05/23/2022 |
REGADENOSON
ANDA #214252 |
ORIG-1 |
REGADENOSON |
IMS LTD |
|
Approval |
| 05/23/2022 |
TYVASO DPI
NDA #214324 |
ORIG-1 |
TREPROSTINIL |
UNITED THERAP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 05/23/2022 |
VTAMA
NDA #215272 |
ORIG-1 |
TAPINAROF |
DERMAVANT SCI |
Type 1 - New Molecular Entity |
Approval |
| 05/24/2022 |
OXISTAT
NDA #020209 |
SUPPL-14 |
OXICONAZOLE NITRATE |
ANI PHARMS |
Labeling |
Approval |
| 05/24/2022 |
TAGAMET HB
NDA #020238 |
SUPPL-26 |
CIMETIDINE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
| 05/24/2022 |
METHADONE HYDROCHLORIDE
NDA #021624 |
SUPPL-15 |
METHADONE HYDROCHLORIDE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
| 05/24/2022 |
REVLIMID
NDA #021880 |
SUPPL-65 |
LENALIDOMIDE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 05/24/2022 |
TADALAFIL
ANDA #206693 |
SUPPL-4 |
TADALAFIL |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/24/2022 |
SILODOSIN
ANDA #210687 |
SUPPL-1 |
SILODOSIN |
MSN |
Manufacturing (CMC) |
Approval |
| 05/24/2022 |
HYDROXYPROGESTERONE CAPROATE
ANDA #211142 |
SUPPL-1 |
HYDROXYPROGESTERONE CAPROATE |
EUGIA PHARMA |
Labeling |
Approval |
| 05/24/2022 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #212699 |
SUPPL-1 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
LUPIN LTD |
Labeling |
Approval |
| 05/24/2022 |
PIRFENIDONE
ANDA #212772 |
ORIG-1 |
PIRFENIDONE |
MSN |
|
Approval |
| 05/24/2022 |
EXEMESTANE
ANDA #213547 |
SUPPL-3 |
EXEMESTANE |
QILU |
Labeling |
Approval |
| 05/24/2022 |
CISATRACURIUM BESYLATE
ANDA #215516 |
ORIG-1 |
CISATRACURIUM BESYLATE |
PIRAMAL CRITICAL |
|
Approval |
| 05/24/2022 |
OMEPRAZOLE MAGNESIUM
ANDA #216096 |
ORIG-1 |
OMEPRAZOLE MAGNESIUM |
L PERRIGO CO |
|
Approval |
| 05/24/2022 |
EMGALITY
BLA #761063 |
SUPPL-6 |
GALCANEZUMAB-GNLM |
ELI LILLY AND CO |
|
Approval |
| 05/25/2022 |
SUCRAID
BLA #020772 |
SUPPL-27 |
SACROSIDASE |
QOL MEDCL |
|
Approval |
| 05/25/2022 |
ZONISAMIDE
ANDA #077625 |
SUPPL-8 |
ZONISAMIDE |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 05/25/2022 |
ZONISAMIDE
ANDA #077634 |
SUPPL-18 |
ZONISAMIDE |
SUN PHARM INDS (IN) |
Labeling |
Approval |
| 05/25/2022 |
ZONISAMIDE
ANDA #077642 |
SUPPL-9 |
ZONISAMIDE |
APOTEX INC |
Labeling |
Approval |
| 05/25/2022 |
ZONISAMIDE
ANDA #077651 |
SUPPL-17 |
ZONISAMIDE |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 05/25/2022 |
ZONISAMIDE
ANDA #077869 |
SUPPL-14 |
ZONISAMIDE |
INVAGEN PHARMS |
Labeling |
Approval |
| 05/25/2022 |
TIZANIDINE HYDROCHLORIDE
ANDA #078868 |
SUPPL-4 |
TIZANIDINE HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #090384 |
ORIG-1 |
PEMETREXED DISODIUM |
FRESENIUS KABI USA |
|
Approval |
| 05/25/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #201356 |
SUPPL-13 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #202111 |
ORIG-1 |
PEMETREXED DISODIUM |
HOSPIRA |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #202596 |
ORIG-1 |
PEMETREXED DISODIUM |
DR REDDYS |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #203485 |
ORIG-1 |
PEMETREXED DISODIUM |
ACCORD HLTHCARE |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #203774 |
ORIG-1 |
PEMETREXED DISODIUM |
APOTEX |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #204890 |
ORIG-1 |
PEMETREXED DISODIUM |
QILU PHARM HAINAN |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #207352 |
ORIG-1 |
PEMETREXED DISODIUM |
NANG KUANG PHARM CO |
|
Approval |
| 05/25/2022 |
TIZANIDINE HYDROCHLORIDE
ANDA #208622 |
SUPPL-2 |
TIZANIDINE HYDROCHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #208696 |
ORIG-1 |
PEMETREXED DISODIUM |
JIANGSU HANSOH PHARM |
|
Approval |
| 05/25/2022 |
POSACONAZOLE
ANDA #208768 |
ORIG-1 |
POSACONAZOLE |
ENDO OPERATIONS |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #209085 |
ORIG-1 |
PEMETREXED DISODIUM |
APOTEX |
|
Approval |
| 05/25/2022 |
FENOFIBRATE (MICRONIZED)
ANDA #209504 |
SUPPL-10 |
FENOFIBRATE |
ANI PHARMS |
Labeling |
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #209851 |
ORIG-1 |
PEMETREXED DISODIUM |
APOTEX |
|
Approval |
| 05/25/2022 |
TIZANIDINE HYDROCHLORIDE
ANDA #210021 |
SUPPL-2 |
TIZANIDINE HYDROCHLORIDE |
CADILA PHARMS LTD |
Labeling |
Approval |
| 05/25/2022 |
SEVELAMER CARBONATE
ANDA #210464 |
SUPPL-1 |
SEVELAMER CARBONATE |
DR REDDYS |
Labeling |
Approval |
| 05/25/2022 |
YUPELRI
NDA #210598 |
SUPPL-3 |
REVEFENACIN |
MYLAN IRELAND LTD |
Labeling |
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #211090 |
ORIG-1 |
PEMETREXED DISODIUM |
BIOCON PHARMA |
|
Approval |
| 05/25/2022 |
TIBSOVO
NDA #211192 |
SUPPL-9 |
IVOSIDENIB |
SERVIER |
Efficacy |
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #211899 |
ORIG-1 |
PEMETREXED DISODIUM |
RELIANCE LIFE |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #214073 |
ORIG-1 |
PEMETREXED DISODIUM |
ZYDUS PHARMS |
|
Approval |
| 05/25/2022 |
PEMETREXED DISODIUM
ANDA #214632 |
ORIG-1 |
PEMETREXED DISODIUM |
EUGIA PHARMA |
|
Approval |
| 05/26/2022 |
CARAC
NDA #020985 |
SUPPL-19 |
FLUOROURACIL |
VALEANT PHARMS NORTH |
Labeling |
Approval |
| 05/26/2022 |
ATNAA
NDA #021175 |
SUPPL-47 |
ATROPINE; PRALIDOXIME CHLORIDE |
US ARMY |
Labeling |
Approval |
| 05/26/2022 |
AVEED
NDA #022219 |
SUPPL-19 |
TESTOSTERONE UNDECANOATE |
ENDO OPERATIONS |
REMS |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093 |
SUPPL-18 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093 |
SUPPL-19 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093 |
SUPPL-20 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093 |
SUPPL-21 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450 |
SUPPL-17 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450 |
SUPPL-21 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450 |
SUPPL-24 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/26/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450 |
SUPPL-26 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/26/2022 |
ATOMOXETINE HYDROCHLORIDE
ANDA #090609 |
SUPPL-1 |
ATOMOXETINE HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 05/26/2022 |
ATOMOXETINE HYDROCHLORIDE
ANDA #090609 |
SUPPL-5 |
ATOMOXETINE HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 05/26/2022 |
CAMPATH
BLA #103948 |
SUPPL-5185 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 05/26/2022 |
LEMTRADA
BLA #103948 |
SUPPL-5185 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 05/26/2022 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #207685 |
SUPPL-1 |
SAPROPTERIN DIHYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 05/26/2022 |
NITISINONE
ANDA #212390 |
ORIG-1 |
NITISINONE |
MEDUNIK |
|
Approval |
| 05/26/2022 |
ROCURONIUM BROMIDE
ANDA #212668 |
ORIG-1 |
ROCURONIUM BROMIDE |
PRINSTON INC |
|
Approval |
| 05/26/2022 |
PAROXETINE HYDROCHLORIDE
ANDA #213612 |
SUPPL-1 |
PAROXETINE HYDROCHLORIDE |
EPIC PHARMA LLC |
Manufacturing (CMC) |
Approval |
| 05/26/2022 |
ALOSETRON HYDROCHLORIDE
ANDA #213614 |
SUPPL-7 |
ALOSETRON HYDROCHLORIDE |
MANKIND PHARMA |
Labeling |
Approval |
| 05/26/2022 |
PEMETREXED DISODIUM
NDA #214657 |
ORIG-1 |
PEMETREXED DISODIUM |
SANDOZ |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 05/26/2022 |
ARFORMOTEROL TARTRATE
ANDA #215385 |
ORIG-1 |
ARFORMOTEROL TARTRATE |
SUN PHARM |
|
Approval |
| 05/26/2022 |
ATROPINE SULFATE
ANDA #216120 |
ORIG-1 |
ATROPINE SULFATE |
AM REGENT |
|
Approval |
| 05/26/2022 |
BUMETANIDE
ANDA #216434 |
ORIG-1 |
BUMETANIDE |
GLAND PHARMA LTD |
|
Approval |
| 05/26/2022 |
FYLNETRA
BLA #761084 |
ORIG-1 |
PEGFILGRASTIM-PBBK |
KASHIV BIOSCIENCES LLC |
|
Approval |
| 05/27/2022 |
CIPRODEX
NDA #021537 |
SUPPL-19 |
CIPROFLOXACIN; DEXAMETHASONE |
SANDOZ |
Manufacturing (CMC) |
Approval |
| 05/27/2022 |
CEFUROXIME AXETIL
ANDA #065135 |
SUPPL-26 |
CEFUROXIME AXETIL |
LUPIN |
Labeling |
Approval |
| 05/27/2022 |
AZITHROMYCIN
ANDA #065212 |
SUPPL-35 |
AZITHROMYCIN |
SANDOZ |
Labeling |
Approval |
| 05/27/2022 |
CEFUROXIME AXETIL
ANDA #065496 |
SUPPL-15 |
CEFUROXIME AXETIL |
ALKEM LABS LTD |
Labeling |
Approval |
| 05/27/2022 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075788 |
SUPPL-21 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
TARO PHARM INDS |
Labeling |
Approval |
| 05/27/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076374 |
SUPPL-11 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 05/27/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076374 |
SUPPL-12 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 05/27/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076374 |
SUPPL-13 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 05/27/2022 |
NITROFURANTOIN
ANDA #091095 |
SUPPL-5 |
NITROFURANTOIN, MACROCRYSTALLINE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 05/27/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524 |
SUPPL-9 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 05/27/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524 |
SUPPL-11 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 05/27/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524 |
SUPPL-12 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 05/27/2022 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524 |
SUPPL-13 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 05/27/2022 |
YERVOY
BLA #125377 |
SUPPL-122 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/27/2022 |
OPDIVO
BLA #125554 |
SUPPL-105 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/27/2022 |
OPDIVO
BLA #125554 |
SUPPL-106 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/27/2022 |
TAFINLAR
NDA #202806 |
SUPPL-23 |
DABRAFENIB MESYLATE |
NOVARTIS |
Efficacy |
Approval |
| 05/27/2022 |
ARIPIPRAZOLE
ANDA #203906 |
SUPPL-9 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 05/27/2022 |
MEKINIST
NDA #204114 |
SUPPL-23 |
TRAMETINIB DIMETHYL SULFOXIDE |
NOVARTIS |
Efficacy |
Approval |
| 05/27/2022 |
TADALAFIL
ANDA #206285 |
SUPPL-3 |
TADALAFIL |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 05/27/2022 |
FENOFIBRATE
ANDA #208709 |
SUPPL-6 |
FENOFIBRATE |
CIPLA |
Labeling |
Approval |
| 05/27/2022 |
TIZANIDINE HYDROCHLORIDE
ANDA #210267 |
SUPPL-2 |
TIZANIDINE HYDROCHLORIDE |
NOVAST LABS |
Labeling |
Approval |
| 05/27/2022 |
AMANTADINE HYDROCHLORIDE
ANDA #212407 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
EDENBRIDGE PHARMS |
|
Approval |
| 05/27/2022 |
EVRYSDI
NDA #213535 |
SUPPL-3 |
RISDIPLAM |
GENENTECH INC |
Efficacy |
Approval |
| 05/27/2022 |
EVRYSDI
NDA #213535 |
SUPPL-5 |
RISDIPLAM |
GENENTECH INC |
Efficacy |
Approval |
| 05/27/2022 |
LEVETIRACETAM
ANDA #215069 |
ORIG-2 |
LEVETIRACETAM |
SCIEGEN PHARMS INC |
|
Approval |
| 05/27/2022 |
IBUPROFEN
ANDA #215311 |
ORIG-1 |
IBUPROFEN |
STRIDES PHARMA |
|
Approval |
| 05/27/2022 |
MINOCYCLINE HYDROCHLORIDE
ANDA #215466 |
ORIG-1 |
MINOCYCLINE HYDROCHLORIDE |
BEXIMCO PHARMS USA |
|
Approval |
| 05/27/2022 |
LEVETIRACETAM
ANDA #216375 |
ORIG-1 |
LEVETIRACETAM |
ALKEM LABS LTD |
|
Approval |
| 05/27/2022 |
BEOVU
BLA #761125 |
SUPPL-8 |
brolucizumab-dbll |
NOVARTIS PHARMS CORP |
|
Approval |
| 05/31/2022 |
ZOCOR
NDA #019766 |
SUPPL-102 |
SIMVASTATIN |
ORGANON |
Labeling |
Approval |
| 05/31/2022 |
PRAVACHOL
NDA #019898 |
SUPPL-70 |
PRAVASTATIN SODIUM |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 05/31/2022 |
GABLOFEN
NDA #022462 |
SUPPL-15 |
BACLOFEN |
PIRAMAL CRITICAL |
Labeling |
Approval |
| 05/31/2022 |
AZITHROMYCIN
ANDA #065179 |
SUPPL-21 |
AZITHROMYCIN |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/31/2022 |
FLUOCINOLONE ACETONIDE
ANDA #203378 |
SUPPL-1 |
FLUOCINOLONE ACETONIDE |
LYNE |
Labeling |
Approval |
| 05/31/2022 |
LINEZOLID
ANDA #205154 |
SUPPL-5 |
LINEZOLID |
MYLAN LABS LTD |
Labeling |
Approval |
| 05/31/2022 |
LINEZOLID
ANDA #205154 |
SUPPL-6 |
LINEZOLID |
MYLAN LABS LTD |
Labeling |
Approval |
| 05/31/2022 |
LINEZOLID
ANDA #205154 |
SUPPL-8 |
LINEZOLID |
MYLAN LABS LTD |
Labeling |
Approval |
| 05/31/2022 |
LINEZOLID
ANDA #205154 |
SUPPL-9 |
LINEZOLID |
MYLAN LABS LTD |
Labeling |
Approval |
| 05/31/2022 |
NEOSTIGMINE METHYLSULFATE
ANDA #208405 |
SUPPL-4 |
NEOSTIGMINE METHYLSULFATE |
ENDO OPERATIONS |
Labeling |
Approval |
| 05/31/2022 |
LACOSAMIDE
ANDA #209301 |
ORIG-1 |
LACOSAMIDE |
HETERO LABS LTD III |
|
Approval |
| 05/31/2022 |
ADAPALENE AND BENZOYL PEROXIDE
ANDA #212464 |
ORIG-1 |
ADAPALENE; BENZOYL PEROXIDE |
PADAGIS ISRAEL |
|
Approval |
| 05/31/2022 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #214111 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
RHODES PHARMS |
|
Approval |
| 05/31/2022 |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #215220 |
ORIG-1 |
SITAGLIPTIN; METFORMIN HYDROCHLORIDE |
AJANTA PHARMA LTD |
|
Tentative Approval |
| 05/31/2022 |
FLUDROCORTISONE ACETATE
ANDA #215279 |
ORIG-1 |
FLUDROCORTISONE ACETATE |
NOVITIUM PHARMA |
|
Approval |
| 05/31/2022 |
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #215434 |
ORIG-1 |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 05/31/2022 |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
ANDA #216204 |
ORIG-1 |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
AUROBINDO PHARMA |
|
Approval |
