| 04/03/2023 |
KEYTRUDA
BLA #125514 |
SUPPL-136 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/03/2023 |
EUCRISA
NDA #207695 |
SUPPL-12 |
CRISABOROLE |
ANACOR PHARMS INC |
Efficacy |
Approval |
| 04/03/2023 |
TREPROSTINIL
ANDA #208906 |
ORIG-1 |
TREPROSTINIL |
ACTAVIS LABS |
|
Tentative Approval |
| 04/03/2023 |
DOXEPIN HYDROCHLORIDE
ANDA #214823 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
MSN |
|
Approval |
| 04/03/2023 |
NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
NDA #215457 |
SUPPL-1 |
NALOXONE HYDROCHLORIDE |
KALEO INC |
Manufacturing (CMC) |
Approval |
| 04/03/2023 |
PADCEV
BLA #761137 |
SUPPL-18 |
ENFORTUMAB VEDOTIN-EJFV |
ASTELLAS |
|
Approval |
| 04/03/2023 |
PADCEV
BLA #761137 |
SUPPL-20 |
ENFORTUMAB VEDOTIN-EJFV |
ASTELLAS |
|
Approval |
| 04/04/2023 |
ALEVE
NDA #020204 |
SUPPL-84 |
NAPROXEN SODIUM |
BAYER |
Manufacturing (CMC) |
Approval |
| 04/04/2023 |
XYREM
NDA #021196 |
SUPPL-42 |
SODIUM OXYBATE |
JAZZ PHARMS |
Labeling |
Approval |
| 04/04/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #200430 |
ORIG-1 |
VENLAFAXINE HYDROCHLORIDE |
NOSTRUM PHARMS LLC |
|
Approval |
| 04/04/2023 |
ROFLUMILAST
ANDA #208213 |
SUPPL-3 |
ROFLUMILAST |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/04/2023 |
ACETAZOLAMIDE
ANDA #211069 |
ORIG-1 |
ACETAZOLAMIDE |
ZYDUS LIFESCIENCES |
|
Approval |
| 04/04/2023 |
XYWAV
NDA #212690 |
SUPPL-11 |
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE |
JAZZ |
Labeling |
Approval |
| 04/04/2023 |
REGADENOSON
ANDA #213856 |
ORIG-1 |
REGADENOSON |
MYLAN |
|
Approval |
| 04/04/2023 |
SIROLIMUS
ANDA #214753 |
SUPPL-1 |
SIROLIMUS |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/04/2023 |
CARBIDOPA AND LEVODOPA
ANDA #215999 |
ORIG-1 |
CARBIDOPA; LEVODOPA |
ZYDUS PHARMS |
|
Approval |
| 04/04/2023 |
NELARABINE
ANDA #216346 |
ORIG-1 |
NELARABINE |
AMNEAL |
|
Approval |
| 04/04/2023 |
ERTUGLIFLOZIN
ANDA #216842 |
ORIG-1 |
ERTUGLIFLOZIN |
ZENARA |
|
Tentative Approval |
| 04/04/2023 |
PROCHLORPERAZINE MALEATE
ANDA #217478 |
ORIG-1 |
PROCHLORPERAZINE MALEATE |
BIONPHARMA |
|
Approval |
| 04/05/2023 |
LIPIODOL
NDA #009190 |
SUPPL-32 |
ETHIODIZED OIL |
GUERBET |
Labeling |
Approval |
| 04/05/2023 |
NORTRIPTYLINE HYDROCHLORIDE
ANDA #075606 |
SUPPL-9 |
NORTRIPTYLINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
| 04/05/2023 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #077753 |
SUPPL-23 |
CIPROFLOXACIN |
HOSPIRA |
Labeling |
Approval |
| 04/05/2023 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #203259 |
SUPPL-2 |
LAMIVUDINE; ZIDOVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
| 04/05/2023 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #203259 |
SUPPL-3 |
LAMIVUDINE; ZIDOVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
| 04/05/2023 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #203259 |
SUPPL-5 |
LAMIVUDINE; ZIDOVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
| 04/05/2023 |
COSELA
NDA #214200 |
SUPPL-4 |
TRILACICLIB DIHYDROCHLORIDE |
G1 THERAP |
Labeling |
Approval |
| 04/05/2023 |
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
ANDA #214401 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
HIKMA |
|
Approval |
| 04/05/2023 |
BEPOTASTINE BESILATE
ANDA #214588 |
ORIG-1 |
BEPOTASTINE BESILATE |
ALEMBIC |
|
Approval |
| 04/06/2023 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #078381 |
SUPPL-10 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/06/2023 |
EFAVIRENZ
ANDA #078886 |
SUPPL-27 |
EFAVIRENZ |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/06/2023 |
LEVETIRACETAM
ANDA #078976 |
SUPPL-15 |
LEVETIRACETAM |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
| 04/06/2023 |
LEVETIRACETAM
ANDA #078976 |
SUPPL-16 |
LEVETIRACETAM |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
| 04/06/2023 |
LEVETIRACETAM
ANDA #078976 |
SUPPL-17 |
LEVETIRACETAM |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
| 04/06/2023 |
ESCITALOPRAM OXALATE
ANDA #090939 |
SUPPL-15 |
ESCITALOPRAM OXALATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 04/06/2023 |
ESCITALOPRAM OXALATE
ANDA #090939 |
SUPPL-17 |
ESCITALOPRAM OXALATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 04/06/2023 |
ESCITALOPRAM OXALATE
ANDA #090939 |
SUPPL-20 |
ESCITALOPRAM OXALATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 04/06/2023 |
ESCITALOPRAM OXALATE
ANDA #090939 |
SUPPL-24 |
ESCITALOPRAM OXALATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 04/06/2023 |
PANTOPRAZOLE SODIUM
ANDA #090970 |
SUPPL-22 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
| 04/06/2023 |
PANTOPRAZOLE SODIUM
ANDA #090970 |
SUPPL-24 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
| 04/06/2023 |
CISATRACURIUM BESYLATE
ANDA #203078 |
SUPPL-1 |
CISATRACURIUM BESYLATE |
HIKMA |
Labeling |
Approval |
| 04/06/2023 |
LANSOPRAZOLE
ANDA #203203 |
SUPPL-10 |
LANSOPRAZOLE |
XIROMED |
Labeling |
Approval |
| 04/06/2023 |
LANSOPRAZOLE
ANDA #203203 |
SUPPL-11 |
LANSOPRAZOLE |
XIROMED |
Labeling |
Approval |
| 04/06/2023 |
LANSOPRAZOLE
ANDA #203203 |
SUPPL-14 |
LANSOPRAZOLE |
XIROMED |
Labeling |
Approval |
| 04/06/2023 |
DILTIAZEM HYDROCHLORIDE
ANDA #216327 |
ORIG-1 |
DILTIAZEM HYDROCHLORIDE |
SCIEGEN PHARMS INC |
|
Approval |
| 04/06/2023 |
CEVIMELINE HYDROCHLORIDE
ANDA #216682 |
ORIG-1 |
CEVIMELINE HYDROCHLORIDE |
RUBICON |
|
Approval |
| 04/06/2023 |
AMJEVITA
BLA #761024 |
SUPPL-11 |
ADALIMUMAB-ATTO |
AMGEN INC |
|
Approval |
| 04/07/2023 |
ATOMOXETINE HYDROCHLORIDE
ANDA #079022 |
SUPPL-7 |
ATOMOXETINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/07/2023 |
ATOMOXETINE HYDROCHLORIDE
ANDA #079022 |
SUPPL-11 |
ATOMOXETINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/07/2023 |
ATOMOXETINE HYDROCHLORIDE
ANDA #079022 |
SUPPL-12 |
ATOMOXETINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/07/2023 |
SUCCINYLCHOLINE CHLORIDE
ANDA #211625 |
SUPPL-2 |
SUCCINYLCHOLINE CHLORIDE |
NIVAGEN PHARMS INC |
Labeling |
Approval |
| 04/07/2023 |
APREMILAST
ANDA #211774 |
ORIG-1 |
APREMILAST |
SHILPA |
|
Approval |
| 04/07/2023 |
ATROPINE SULFATE
ANDA #212868 |
SUPPL-3 |
ATROPINE SULFATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/07/2023 |
AZITHROMYCIN
ANDA #213056 |
ORIG-1 |
AZITHROMYCIN |
ZYDUS PHARMS |
|
Approval |
| 04/07/2023 |
PROCHLORPERAZINE EDISYLATE
ANDA #213626 |
SUPPL-1 |
PROCHLORPERAZINE EDISYLATE |
VIWIT PHARM |
Labeling |
Approval |
| 04/07/2023 |
PROCHLORPERAZINE EDISYLATE
ANDA #213630 |
SUPPL-1 |
PROCHLORPERAZINE EDISYLATE |
HIKMA |
Labeling |
Approval |
| 04/07/2023 |
DEFERASIROX
ANDA #214180 |
SUPPL-1 |
DEFERASIROX |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/07/2023 |
DEFERASIROX
ANDA #214180 |
SUPPL-4 |
DEFERASIROX |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/07/2023 |
MEMANTINE;DONEPEZIL HYDROCHLORIDES
ANDA #216901 |
ORIG-1 |
MEMANTINE;DONEPEZIL HYDROCHLORIDES |
XIAMEN LP PHARM CO |
|
Tentative Approval |
| 04/10/2023 |
KITABIS PAK
NDA #205433 |
SUPPL-8 |
TOBRAMYCIN |
PULMOFLOW INC |
Labeling |
Approval |
| 04/10/2023 |
MONTELUKAST SODIUM
ANDA #206112 |
SUPPL-1 |
MONTELUKAST SODIUM |
L PERRIGO CO |
Labeling |
Approval |
| 04/10/2023 |
MONTELUKAST SODIUM
ANDA #206112 |
SUPPL-2 |
MONTELUKAST SODIUM |
L PERRIGO CO |
Labeling |
Approval |
| 04/10/2023 |
MONTELUKAST SODIUM
ANDA #206112 |
SUPPL-3 |
MONTELUKAST SODIUM |
L PERRIGO CO |
Labeling |
Approval |
| 04/10/2023 |
MONTELUKAST SODIUM
ANDA #206112 |
SUPPL-4 |
MONTELUKAST SODIUM |
L PERRIGO CO |
Labeling |
Approval |
| 04/10/2023 |
POTASSIUM CITRATE
ANDA #206813 |
SUPPL-4 |
POTASSIUM CITRATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/10/2023 |
POTASSIUM CITRATE
ANDA #206813 |
SUPPL-5 |
POTASSIUM CITRATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/10/2023 |
POTASSIUM CITRATE
ANDA #206813 |
SUPPL-7 |
POTASSIUM CITRATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/10/2023 |
RINVOQ
NDA #211675 |
SUPPL-12 |
UPADACITINIB |
ABBVIE |
Labeling |
Approval |
| 04/10/2023 |
TAVABOROLE
ANDA #212294 |
ORIG-1 |
TAVABOROLE |
ZYDUS LIFESCIENCES |
|
Approval |
| 04/10/2023 |
CELECOXIB
ANDA #212564 |
ORIG-1 |
CELECOXIB |
YABAO PHARM |
|
Approval |
| 04/10/2023 |
CHLORZOXAZONE
ANDA #214702 |
ORIG-1 |
CHLORZOXAZONE |
COREPHARMA |
|
Approval |
| 04/10/2023 |
NISOLDIPINE
ANDA #216606 |
ORIG-1 |
NISOLDIPINE |
AMTA |
|
Approval |
| 04/11/2023 |
CARBATROL
NDA #020712 |
SUPPL-38 |
CARBAMAZEPINE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/11/2023 |
TECHNETIUM TC 99M SESTAMIBI
ANDA #079157 |
SUPPL-14 |
TECHNETIUM TC-99M SESTAMIBI KIT |
SUN PHARM INDS INC |
Labeling |
Approval |
| 04/11/2023 |
AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090483 |
SUPPL-2 |
AMLODIPINE BESYLATE; VALSARTAN |
MYLAN |
Labeling |
Approval |
| 04/11/2023 |
AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090483 |
SUPPL-5 |
AMLODIPINE BESYLATE; VALSARTAN |
MYLAN |
Labeling |
Approval |
| 04/11/2023 |
AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090483 |
SUPPL-9 |
AMLODIPINE BESYLATE; VALSARTAN |
MYLAN |
Labeling |
Approval |
| 04/11/2023 |
TYSABRI
BLA #125104 |
SUPPL-976 |
NATALIZUMAB |
BIOGEN IDEC |
|
Approval |
| 04/11/2023 |
TYSABRI
BLA #125104 |
SUPPL-979 |
NATALIZUMAB |
BIOGEN IDEC |
|
Approval |
| 04/11/2023 |
ADAPALENE
ANDA #201000 |
SUPPL-6 |
ADAPALENE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
| 04/11/2023 |
METOPROLOL SUCCINATE
ANDA #202033 |
SUPPL-9 |
METOPROLOL SUCCINATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 04/11/2023 |
METOPROLOL SUCCINATE
ANDA #202033 |
SUPPL-11 |
METOPROLOL SUCCINATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 04/11/2023 |
COLESEVELAM HYDROCHLORIDE
ANDA #203480 |
SUPPL-6 |
COLESEVELAM HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/11/2023 |
DALFAMPRIDINE
ANDA #210158 |
SUPPL-5 |
DALFAMPRIDINE |
MICRO LABS |
Labeling |
Approval |
| 04/11/2023 |
AZITHROMYCIN
ANDA #213275 |
ORIG-1 |
AZITHROMYCIN |
ZYDUS PHARMS |
|
Approval |
| 04/11/2023 |
VALGANCICLOVIR HYDROCHLORIDE
ANDA #216317 |
ORIG-1 |
VALGANCICLOVIR HYDROCHLORIDE |
APPCO |
|
Approval |
| 04/12/2023 |
KETAMINE HYDROCHLORIDE
ANDA #074524 |
SUPPL-19 |
KETAMINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/12/2023 |
KETAMINE HYDROCHLORIDE
ANDA #074549 |
SUPPL-31 |
KETAMINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 04/12/2023 |
LEVALBUTEROL HYDROCHLORIDE
ANDA #078309 |
SUPPL-15 |
LEVALBUTEROL HYDROCHLORIDE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
| 04/12/2023 |
VASOSTRICT
NDA #204485 |
SUPPL-30 |
VASOPRESSIN |
PAR STERILE PRODUCTS |
Manufacturing (CMC) |
Approval |
| 04/12/2023 |
PRASUGREL
ANDA #205987 |
SUPPL-5 |
PRASUGREL HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/12/2023 |
PANTOPRAZOLE SODIUM
ANDA #209524 |
SUPPL-1 |
PANTOPRAZOLE SODIUM |
HANGZHOU ZHONGMEI |
Labeling |
Approval |
| 04/12/2023 |
DEFERASIROX
ANDA #211824 |
SUPPL-3 |
DEFERASIROX |
ALEMBIC |
Labeling |
Approval |
| 04/12/2023 |
DEFERASIROX
ANDA #211824 |
SUPPL-7 |
DEFERASIROX |
ALEMBIC |
Labeling |
Approval |
| 04/12/2023 |
NIACIN
ANDA #214428 |
SUPPL-1 |
NIACIN |
BEIJING |
Labeling |
Approval |
| 04/12/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #214691 |
ORIG-1 |
VENLAFAXINE HYDROCHLORIDE |
AJANTA PHARMA LTD |
|
Approval |
| 04/12/2023 |
PALBOCICLIB
ANDA #214758 |
ORIG-1 |
PALBOCICLIB |
MSN PHARMACEUTICALS INC |
|
Tentative Approval |
| 04/12/2023 |
BUDESONIDE
ANDA #215328 |
ORIG-1 |
BUDESONIDE |
PADAGIS ISRAEL |
|
Approval |
| 04/12/2023 |
DOXYCYCLINE HYCLATE
ANDA #215583 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
GLAND PHARMA LTD |
|
Approval |
| 04/12/2023 |
LOTEPREDNOL ETABONATE
ANDA #215933 |
ORIG-1 |
LOTEPREDNOL ETABONATE |
SENTISS |
|
Approval |
| 04/12/2023 |
SORAFENIB TOSYLATE
ANDA #217095 |
ORIG-1 |
SORAFENIB TOSYLATE |
TORRENT |
|
Approval |
| 04/13/2023 |
BSS PLUS
NDA #018469 |
SUPPL-60 |
CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
ALCON |
Labeling |
Approval |
| 04/13/2023 |
ZORTRESS
NDA #021560 |
SUPPL-31 |
EVEROLIMUS |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 04/13/2023 |
DEXILANT
NDA #022287 |
SUPPL-37 |
DEXLANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/13/2023 |
CAPRELSA
NDA #022405 |
SUPPL-21 |
VANDETANIB |
GENZYME CORP |
REMS |
Approval |
| 04/13/2023 |
CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #078933 |
SUPPL-5 |
CETIRIZINE HYDROCHLORIDE |
MARKSANS PHARMA |
Manufacturing (CMC) |
Approval |
| 04/13/2023 |
CETIRIZINE HYDROCHLORIDE HIVES
ANDA #078933 |
SUPPL-5 |
CETIRIZINE HYDROCHLORIDE |
MARKSANS PHARMA |
Manufacturing (CMC) |
Approval |
| 04/13/2023 |
PRAVASTATIN SODIUM
ANDA #203367 |
SUPPL-7 |
PRAVASTATIN SODIUM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/13/2023 |
ACETAMINOPHEN
ANDA #207229 |
SUPPL-9 |
ACETAMINOPHEN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/13/2023 |
ACETAMINOPHEN
ANDA #207229 |
SUPPL-10 |
ACETAMINOPHEN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/13/2023 |
ACETAMINOPHEN
ANDA #207229 |
SUPPL-13 |
ACETAMINOPHEN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/13/2023 |
ACETAMINOPHEN
ANDA #207229 |
SUPPL-14 |
ACETAMINOPHEN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/13/2023 |
ROFLUMILAST
ANDA #208247 |
SUPPL-2 |
ROFLUMILAST |
STRIDES PHARMA |
Labeling |
Approval |
| 04/13/2023 |
METHYLPREDNISOLONE ACETATE
ANDA #211930 |
ORIG-1 |
METHYLPREDNISOLONE ACETATE |
EUGIA PHARMA |
|
Approval |
| 04/13/2023 |
OLOPATADINE HYDROCHLORIDE
ANDA #213757 |
SUPPL-1 |
OLOPATADINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/13/2023 |
TESTOSTERONE CYPIONATE
ANDA #215351 |
ORIG-1 |
TESTOSTERONE CYPIONATE |
XIROMED |
|
Approval |
| 04/13/2023 |
TEPEZZA
BLA #761143 |
SUPPL-24 |
TEPROTUMUMAB-TRBW |
HORIZON THERAPEUTICS IRELAND |
|
Approval |
| 04/14/2023 |
LUPRON DEPOT-PED KIT
NDA #020263 |
SUPPL-53 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Efficacy |
Approval |
| 04/14/2023 |
REYATAZ
NDA #021567 |
SUPPL-47 |
ATAZANAVIR SULFATE |
BRISTOL MYERS SQUIBB |
Manufacturing (CMC) |
Approval |
| 04/14/2023 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #090080 |
SUPPL-4 |
MOXIFLOXACIN HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 04/14/2023 |
RIZAFILM
NDA #205394 |
ORIG-1 |
RIZATRIPTAN BENZOATE |
GENSCO |
Type 3 - New Dosage Form |
Approval |
| 04/14/2023 |
KAPSPARGO SPRINKLE
NDA #210428 |
SUPPL-6 |
METOPROLOL SUCCINATE |
SPIL |
Labeling |
Approval |
| 04/14/2023 |
FOSAPREPITANT DIMEGLUMINE
ANDA #214616 |
SUPPL-1 |
FOSAPREPITANT DIMEGLUMINE |
ASPIRO |
Labeling |
Approval |
| 04/14/2023 |
FOSAPREPITANT DIMEGLUMINE
ANDA #214616 |
SUPPL-2 |
FOSAPREPITANT DIMEGLUMINE |
ASPIRO |
Labeling |
Approval |
| 04/14/2023 |
ISOPROTERENOL HYDROCHLORIDE
ANDA #215557 |
ORIG-1 |
ISOPROTERENOL HYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
| 04/14/2023 |
BLUDIGO
NDA #216264 |
SUPPL-1 |
INDIGOTINDISULFONATE SODIUM |
PROVEPHARM SAS |
Labeling |
Approval |
| 04/14/2023 |
NITROFURANTOIN
ANDA #216385 |
ORIG-1 |
NITROFURANTOIN |
NOVITIUM PHARMA |
|
Approval |
| 04/14/2023 |
PIPERACILLIN AND TAZOBACTAM
ANDA #217243 |
ORIG-1 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SHANDONG |
|
Approval |
| 04/14/2023 |
HYRIMOZ
BLA #761071 |
SUPPL-15 |
ADALIMUMAB-ADAZ |
SANDOZ INC |
|
Approval |
| 04/17/2023 |
EXCEDRIN (MIGRAINE RELIEF)
NDA #020802 |
SUPPL-43 |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 04/17/2023 |
ULORIC
NDA #021856 |
SUPPL-15 |
FEBUXOSTAT |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/17/2023 |
PREDNISONE
ANDA #040362 |
SUPPL-18 |
PREDNISONE |
JUBILANT CADISTA |
Manufacturing (CMC) |
Approval |
| 04/17/2023 |
VALACYCLOVIR HYDROCHLORIDE
ANDA #201506 |
SUPPL-17 |
VALACYCLOVIR HYDROCHLORIDE |
JUBILANT GENERICS |
Labeling |
Approval |
| 04/17/2023 |
VALACYCLOVIR HYDROCHLORIDE
ANDA #201506 |
SUPPL-22 |
VALACYCLOVIR HYDROCHLORIDE |
JUBILANT GENERICS |
Labeling |
Approval |
| 04/17/2023 |
ESTRADIOL
ANDA #204379 |
ORIG-1 |
ESTRADIOL |
ZYDUS PHARMS |
|
Approval |
| 04/17/2023 |
TACROLIMUS
ANDA #210929 |
ORIG-1 |
TACROLIMUS |
HANGZHOU ZHONGMEI |
|
Approval |
| 04/17/2023 |
TURALIO
NDA #211810 |
SUPPL-11 |
PEXIDARTINIB HYDROCHLORIDE |
DAIICHI SANKYO INC |
REMS |
Approval |
| 04/17/2023 |
ROFLUMILAST
ANDA #213298 |
ORIG-1 |
ROFLUMILAST |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/17/2023 |
QULIPTA
NDA #215206 |
SUPPL-4 |
ATOGEPANT |
ABBVIE |
Efficacy |
Approval |
| 04/17/2023 |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE
ANDA #216159 |
ORIG-1 |
MIDAZOLAM |
HIKMA |
|
Approval |
| 04/17/2023 |
PROCHLORPERAZINE MALEATE
ANDA #216598 |
ORIG-1 |
PROCHLORPERAZINE MALEATE |
AMNEAL |
|
Approval |
| 04/18/2023 |
GRALISE
NDA #022544 |
SUPPL-29 |
GABAPENTIN |
ALMATICA |
Manufacturing (CMC) |
Approval |
| 04/18/2023 |
HALOPERIDOL
ANDA #076774 |
SUPPL-9 |
HALOPERIDOL LACTATE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 04/18/2023 |
ABACAVIR SULFATE AND LAMIVUDINE
ANDA #090159 |
SUPPL-4 |
ABACAVIR SULFATE; LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/18/2023 |
ABACAVIR SULFATE AND LAMIVUDINE
ANDA #090159 |
SUPPL-7 |
ABACAVIR SULFATE; LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/18/2023 |
GABAPENTIN
ANDA #090705 |
SUPPL-31 |
GABAPENTIN |
INVAGEN PHARMS |
Labeling |
Approval |
| 04/18/2023 |
GABAPENTIN
ANDA #090858 |
SUPPL-31 |
GABAPENTIN |
ALKEM |
Labeling |
Approval |
| 04/18/2023 |
GABAPENTIN
ANDA #090858 |
SUPPL-33 |
GABAPENTIN |
ALKEM |
Labeling |
Approval |
| 04/18/2023 |
GABAPENTIN
ANDA #090858 |
SUPPL-35 |
GABAPENTIN |
ALKEM |
Labeling |
Approval |
| 04/18/2023 |
NEUPOGEN
BLA #103353 |
SUPPL-5198 |
FILGRASTIM |
AMGEN |
|
Approval |
| 04/18/2023 |
RETACRIT
BLA #125545 |
SUPPL-22 |
EPOETIN ALFA-EPBX |
HOSPIRA INC |
|
Approval |
| 04/18/2023 |
GLYCOPYRROLATE
ANDA #202675 |
SUPPL-4 |
GLYCOPYRROLATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/18/2023 |
ACETAMINOPHEN
ANDA #205746 |
ORIG-1 |
ACETAMINOPHEN |
WOCKHARDT BIO AG |
|
Approval |
| 04/18/2023 |
CLOFARABINE
ANDA #207831 |
SUPPL-4 |
CLOFARABINE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 04/18/2023 |
ROFLUMILAST
ANDA #208303 |
ORIG-2 |
ROFLUMILAST |
ZYDUS PHARMS |
|
Approval |
| 04/18/2023 |
BETAMETHASONE VALERATE
ANDA #210639 |
ORIG-1 |
BETAMETHASONE VALERATE |
XIROMED |
|
Approval |
| 04/18/2023 |
MACITENTAN
ANDA #211198 |
ORIG-1 |
MACITENTAN |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/18/2023 |
ROFLUMILAST
ANDA #212490 |
ORIG-1 |
ROFLUMILAST |
ALKEM LABS LTD |
|
Approval |
| 04/18/2023 |
CLOFARABINE
ANDA #213461 |
SUPPL-2 |
CLOFARABINE |
MEITHEAL |
Labeling |
Approval |
| 04/18/2023 |
CEVIMELINE HYDROCHLORIDE
ANDA #215056 |
ORIG-1 |
CEVIMELINE HYDROCHLORIDE |
AUROBINDO PHARMA |
|
Approval |
| 04/18/2023 |
PADCEV
BLA #761137 |
SUPPL-19 |
ENFORTUMAB VEDOTIN-EJFV |
ASTELLAS |
|
Approval |
| 04/19/2023 |
DIFFERIN
NDA #022502 |
SUPPL-10 |
ADAPALENE |
GALDERMA LABS LP |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #077577 |
SUPPL-4 |
ONDANSETRON HYDROCHLORIDE |
WOCKHARDT |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #077577 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
WOCKHARDT |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077716 |
SUPPL-6 |
ONDANSETRON HYDROCHLORIDE |
WOCKHARDT |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077716 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
WOCKHARDT |
Labeling |
Approval |
| 04/19/2023 |
CETIRIZINE HYDROCHLORIDE
ANDA #078870 |
SUPPL-6 |
CETIRIZINE HYDROCHLORIDE |
APOZEAL PHARMS |
Labeling |
Approval |
| 04/19/2023 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #079031 |
SUPPL-6 |
METHYLPHENIDATE HYDROCHLORIDE |
BARR LABS INC |
Labeling |
Approval |
| 04/19/2023 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #079031 |
SUPPL-7 |
METHYLPHENIDATE HYDROCHLORIDE |
BARR LABS INC |
Labeling |
Approval |
| 04/19/2023 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #079031 |
SUPPL-8 |
METHYLPHENIDATE HYDROCHLORIDE |
BARR LABS INC |
Labeling |
Approval |
| 04/19/2023 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #079031 |
SUPPL-10 |
METHYLPHENIDATE HYDROCHLORIDE |
BARR LABS INC |
Labeling |
Approval |
| 04/19/2023 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #079031 |
SUPPL-14 |
METHYLPHENIDATE HYDROCHLORIDE |
BARR LABS INC |
Labeling |
Approval |
| 04/19/2023 |
RIBAVIRIN
ANDA #079111 |
SUPPL-11 |
RIBAVIRIN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/19/2023 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #079124 |
SUPPL-20 |
LAMIVUDINE; ZIDOVUDINE |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #090116 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #090116 |
SUPPL-9 |
ONDANSETRON HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #090424 |
SUPPL-19 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #090681 |
SUPPL-5 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #090681 |
SUPPL-7 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #090681 |
SUPPL-8 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #090681 |
SUPPL-11 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #090681 |
SUPPL-12 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #090883 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
| 04/19/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #090883 |
SUPPL-9 |
ONDANSETRON HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
| 04/19/2023 |
SILDENAFIL CITRATE
ANDA #202255 |
ORIG-1 |
SILDENAFIL CITRATE |
MACLEODS PHARMS LTD |
|
Approval |
| 04/19/2023 |
CISATRACURIUM BESYLATE
ANDA #203079 |
ORIG-1 |
CISATRACURIUM BESYLATE |
HIKMA |
|
Approval |
| 04/19/2023 |
TACROLIMUS
ANDA #203740 |
SUPPL-3 |
TACROLIMUS |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/19/2023 |
TACROLIMUS
ANDA #203740 |
SUPPL-5 |
TACROLIMUS |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/19/2023 |
TACROLIMUS
ANDA #203740 |
SUPPL-9 |
TACROLIMUS |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #204203 |
SUPPL-14 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
| 04/19/2023 |
SEVELAMER CARBONATE
ANDA #206100 |
ORIG-1 |
SEVELAMER CARBONATE |
MACLEODS PHARMS LTD |
|
Approval |
| 04/19/2023 |
DALFAMPRIDINE
ANDA #206836 |
SUPPL-4 |
DALFAMPRIDINE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #207655 |
SUPPL-9 |
QUETIAPINE FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/19/2023 |
QUETIAPINE FUMARATE
ANDA #208781 |
SUPPL-1 |
QUETIAPINE FUMARATE |
PRINSTON INC |
Labeling |
Approval |
| 04/19/2023 |
CLOBAZAM
ANDA #208785 |
SUPPL-2 |
CLOBAZAM |
HIKMA |
Labeling |
Approval |
| 04/19/2023 |
METOPROLOL TARTRATE
ANDA #212402 |
ORIG-1 |
METOPROLOL TARTRATE |
ZYDUS PHARMS |
|
Approval |
| 04/19/2023 |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #214698 |
SUPPL-2 |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
DR REDDYS |
Labeling |
Approval |
| 04/19/2023 |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #215835 |
SUPPL-1 |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
MICRO LABS |
Labeling |
Approval |
| 04/19/2023 |
DEXAMETHASONE
ANDA #217001 |
ORIG-1 |
DEXAMETHASONE |
BIONPHARMA |
|
Approval |
| 04/19/2023 |
ACETYLCYSTEINE
ANDA #217182 |
ORIG-1 |
ACETYLCYSTEINE |
STERISCIENCE |
|
Approval |
| 04/19/2023 |
POLIVY
BLA #761121 |
SUPPL-8 |
POLATUZUMAB VEDOTIN-PIIQ |
GENENTECH |
|
Approval |
| 04/20/2023 |
LORYNA
ANDA #079221 |
SUPPL-16 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/20/2023 |
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #086513 |
SUPPL-80 |
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
MYLAN |
Labeling |
Approval |
| 04/20/2023 |
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #086513 |
SUPPL-82 |
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
MYLAN |
Labeling |
Approval |
| 04/20/2023 |
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #086513 |
SUPPL-86 |
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
MYLAN |
Labeling |
Approval |
| 04/20/2023 |
SYEDA
ANDA #090114 |
SUPPL-11 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/20/2023 |
SYEDA
ANDA #090114 |
SUPPL-14 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/20/2023 |
SYEDA
ANDA #090114 |
SUPPL-16 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/20/2023 |
BOSULIF
NDA #203341 |
SUPPL-24 |
BOSUTINIB MONOHYDRATE |
PF PRISM CV |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206252 |
SUPPL-2 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206252 |
SUPPL-4 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206252 |
SUPPL-5 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206252 |
SUPPL-7 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206252 |
SUPPL-8 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206260 |
SUPPL-7 |
QUETIAPINE FUMARATE |
PHARMADAX INC |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206260 |
SUPPL-8 |
QUETIAPINE FUMARATE |
PHARMADAX INC |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #206260 |
SUPPL-10 |
QUETIAPINE FUMARATE |
PHARMADAX INC |
Labeling |
Approval |
| 04/20/2023 |
SAXENDA
NDA #206321 |
SUPPL-16 |
LIRAGLUTIDE |
NOVO |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #208947 |
SUPPL-3 |
QUETIAPINE FUMARATE |
NOVAST LABS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #208947 |
SUPPL-4 |
QUETIAPINE FUMARATE |
NOVAST LABS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #208947 |
SUPPL-5 |
QUETIAPINE FUMARATE |
NOVAST LABS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #211405 |
SUPPL-1 |
QUETIAPINE FUMARATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #211405 |
SUPPL-2 |
QUETIAPINE FUMARATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #211405 |
SUPPL-3 |
QUETIAPINE FUMARATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #211405 |
SUPPL-4 |
QUETIAPINE FUMARATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #211405 |
SUPPL-5 |
QUETIAPINE FUMARATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/20/2023 |
QUETIAPINE FUMARATE
ANDA #211405 |
SUPPL-7 |
QUETIAPINE FUMARATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/20/2023 |
DAYVIGO
NDA #212028 |
SUPPL-8 |
LEMBOREXANT |
EISAI INC |
Efficacy |
Approval |
| 04/20/2023 |
HALOBETASOL PROPIONATE; TAZAROTENE
ANDA #217190 |
ORIG-1 |
HALOBETASOL PROPIONATE;TAZAROTENE |
TARO PHARMS |
|
Tentative Approval |
| 04/20/2023 |
ARSENIC TRIOXIDE
ANDA #217413 |
ORIG-1 |
ARSENIC TRIOXIDE |
ORBICULAR |
|
Approval |
| 04/20/2023 |
ICOSAPENT ETHYL
ANDA #217656 |
ORIG-1 |
ICOSAPENT ETHYL |
ZYDUS |
|
Approval |
| 04/21/2023 |
TICAGRELOR
ANDA #208567 |
ORIG-1 |
TICAGRELOR |
ALKEM LABS LTD |
|
Approval |
| 04/21/2023 |
BRUKINSA
NDA #213217 |
SUPPL-10 |
ZANUBRUTINIB |
BEIGENE |
Labeling |
Approval |
| 04/21/2023 |
PEMETREXED DISODIUM
NDA #214657 |
SUPPL-3 |
PEMETREXED DISODIUM |
SANDOZ |
Labeling |
Approval |
| 04/21/2023 |
ADRENALIN
NDA #215875 |
ORIG-1 |
EPINEPHRINE |
PAR STERILE PRODUCTS |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/21/2023 |
METRONIDAZOLE
ANDA #217128 |
ORIG-1 |
METRONIDAZOLE |
ZYDUS LIFESCIENCES |
|
Approval |
| 04/23/2023 |
ASCOR
NDA #209112 |
SUPPL-8 |
ASCORBIC ACID |
MCGUFF |
Manufacturing (CMC) |
Approval |
| 04/24/2023 |
ZEGERID OTC
NDA #022281 |
SUPPL-17 |
OMEPRAZOLE; SODIUM BICARBONATE |
RILEY CONSUMER |
Labeling |
Approval |
| 04/24/2023 |
STAXYN
NDA #200179 |
SUPPL-7 |
VARDENAFIL HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/24/2023 |
TADALAFIL
ANDA #209907 |
SUPPL-5 |
TADALAFIL |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/24/2023 |
LUMAKRAS
NDA #214665 |
SUPPL-4 |
SOTORASIB |
AMGEN INC |
Labeling |
Approval |
| 04/24/2023 |
FAMOTIDINE
ANDA #217375 |
ORIG-1 |
FAMOTIDINE |
ALKEM LABS LTD |
|
Approval |
| 04/25/2023 |
ISOVUE-128
NDA #018735 |
SUPPL-70 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-200
NDA #018735 |
SUPPL-70 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-250
NDA #018735 |
SUPPL-70 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-300
NDA #018735 |
SUPPL-70 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-370
NDA #018735 |
SUPPL-70 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-M 200
NDA #018735 |
SUPPL-70 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-M 300
NDA #018735 |
SUPPL-70 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 12
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 140
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 180
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 210
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 240
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 300
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 350
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 70
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 9
NDA #018956 |
SUPPL-116 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 160
NDA #019710 |
SUPPL-67 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 240
NDA #019710 |
SUPPL-67 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 300
NDA #019710 |
SUPPL-67 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 320
NDA #019710 |
SUPPL-67 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 350
NDA #019710 |
SUPPL-67 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
ULTRAVIST 150
NDA #020220 |
SUPPL-56 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/25/2023 |
ULTRAVIST 240
NDA #020220 |
SUPPL-56 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/25/2023 |
ULTRAVIST 300
NDA #020220 |
SUPPL-56 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/25/2023 |
ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220 |
SUPPL-56 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/25/2023 |
ULTRAVIST 370
NDA #020220 |
SUPPL-56 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-200
NDA #020327 |
SUPPL-25 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-250
NDA #020327 |
SUPPL-25 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-300
NDA #020327 |
SUPPL-25 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
ISOVUE-370
NDA #020327 |
SUPPL-25 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 04/25/2023 |
VISIPAQUE 270
NDA #020351 |
SUPPL-57 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
VISIPAQUE 320
NDA #020351 |
SUPPL-57 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 240
NDA #020608 |
SUPPL-49 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 300
NDA #020608 |
SUPPL-49 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OMNIPAQUE 350
NDA #020608 |
SUPPL-49 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
VISIPAQUE 270
NDA #020808 |
SUPPL-35 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
VISIPAQUE 320
NDA #020808 |
SUPPL-35 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 240
NDA #020923 |
SUPPL-30 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 300
NDA #020923 |
SUPPL-30 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 320
NDA #020923 |
SUPPL-30 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
OPTIRAY 350
NDA #020923 |
SUPPL-30 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/25/2023 |
ULTRAVIST (PHARMACY BULK)
NDA #021425 |
SUPPL-38 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/25/2023 |
METAXALONE
ANDA #040445 |
SUPPL-9 |
METAXALONE |
SANDOZ |
Labeling |
Approval |
| 04/25/2023 |
DIAZEPAM
ANDA #071583 |
SUPPL-26 |
DIAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 04/25/2023 |
DIAZEPAM
ANDA #072079 |
SUPPL-53 |
DIAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 04/25/2023 |
LEVOCARNITINE
ANDA #075861 |
SUPPL-12 |
LEVOCARNITINE |
AM REGENT |
Manufacturing (CMC) |
Approval |
| 04/25/2023 |
TELMISARTAN
ANDA #090032 |
SUPPL-12 |
TELMISARTAN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/25/2023 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647 |
SUPPL-13 |
TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/25/2023 |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
ANDA #090654 |
SUPPL-5 |
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
SUN PHARM INDS |
Labeling |
Approval |
| 04/25/2023 |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
ANDA #090654 |
SUPPL-7 |
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
SUN PHARM INDS |
Labeling |
Approval |
| 04/25/2023 |
URSODIOL
ANDA #090801 |
SUPPL-8 |
URSODIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/25/2023 |
METRONIDAZOLE
ANDA #090903 |
SUPPL-8 |
METRONIDAZOLE |
CHARTWELL RX |
Labeling |
Approval |
| 04/25/2023 |
ABACAVIR SULFATE
ANDA #091294 |
SUPPL-10 |
ABACAVIR SULFATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 04/25/2023 |
RAMELTEON
ANDA #091610 |
SUPPL-5 |
RAMELTEON |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 04/25/2023 |
ATORVASTATIN CALCIUM
ANDA #091650 |
SUPPL-24 |
ATORVASTATIN CALCIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 04/25/2023 |
ATORVASTATIN CALCIUM
ANDA #202357 |
SUPPL-21 |
ATORVASTATIN CALCIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 04/25/2023 |
SPIRONOLACTONE
ANDA #203512 |
SUPPL-8 |
SPIRONOLACTONE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/25/2023 |
METAXALONE
ANDA #208774 |
SUPPL-1 |
METAXALONE |
APPCO |
Labeling |
Approval |
| 04/25/2023 |
TAZAROTENE
ANDA #213079 |
ORIG-1 |
TAZAROTENE |
PADAGIS ISRAEL |
|
Approval |
| 04/25/2023 |
QALSODY
NDA #215887 |
ORIG-1 |
TOFERSEN |
BIOGEN MA |
Type 1 - New Molecular Entity |
Approval |
| 04/26/2023 |
CONRAY
NDA #013295 |
SUPPL-73 |
IOTHALAMATE MEGLUMINE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/26/2023 |
CONRAY 43
NDA #013295 |
SUPPL-73 |
IOTHALAMATE MEGLUMINE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 04/26/2023 |
HALOPERIDOL DECANOATE
ANDA #075305 |
SUPPL-25 |
HALOPERIDOL DECANOATE |
HIKMA |
Labeling |
Approval |
| 04/26/2023 |
PRAVASTATIN SODIUM
ANDA #076341 |
SUPPL-26 |
PRAVASTATIN SODIUM |
APOTEX |
Labeling |
Approval |
| 04/26/2023 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076780 |
SUPPL-17 |
ONDANSETRON HYDROCHLORIDE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/26/2023 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076780 |
SUPPL-19 |
ONDANSETRON HYDROCHLORIDE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/26/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #076781 |
SUPPL-14 |
ONDANSETRON HYDROCHLORIDE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/26/2023 |
ONDANSETRON HYDROCHLORIDE
ANDA #076781 |
SUPPL-16 |
ONDANSETRON HYDROCHLORIDE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/26/2023 |
CLOZAPINE
ANDA #090308 |
SUPPL-12 |
CLOZAPINE |
BARR LABS INC |
Labeling |
Approval |
| 04/26/2023 |
CLOPIDOGREL BISULFATE
ANDA #090844 |
SUPPL-16 |
CLOPIDOGREL BISULFATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 04/26/2023 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091351 |
SUPPL-6 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
LUPIN LTD |
Labeling |
Approval |
| 04/26/2023 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091351 |
SUPPL-10 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
LUPIN LTD |
Labeling |
Approval |
| 04/26/2023 |
LATANOPROST
ANDA #091449 |
SUPPL-10 |
LATANOPROST |
SANDOZ |
Labeling |
Approval |
| 04/26/2023 |
CAMPATH
BLA #103948 |
SUPPL-5188 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 04/26/2023 |
LEMTRADA
BLA #103948 |
SUPPL-5188 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 04/26/2023 |
CLOZAPINE
ANDA #201824 |
SUPPL-22 |
CLOZAPINE |
MYLAN |
Labeling |
Approval |
| 04/26/2023 |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
ANDA #202509 |
SUPPL-16 |
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE |
ANCHEN PHARMS |
Labeling |
Approval |
| 04/26/2023 |
DUTASTERIDE
ANDA #202660 |
SUPPL-3 |
DUTASTERIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/26/2023 |
CLOZAPINE
ANDA #203039 |
SUPPL-13 |
CLOZAPINE |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/26/2023 |
VERSACLOZ
NDA #203479 |
SUPPL-21 |
CLOZAPINE |
TASMAN PHARMA |
Labeling |
Approval |
| 04/26/2023 |
METAXALONE
ANDA #203695 |
SUPPL-2 |
METAXALONE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 04/26/2023 |
SPIRONOLACTONE
ANDA #205936 |
SUPPL-7 |
SPIRONOLACTONE |
ZYDUS PHARMS |
Labeling |
Approval |
| 04/26/2023 |
ZEJULA
NDA #208447 |
SUPPL-27 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Efficacy |
Approval |
| 04/26/2023 |
CLINDAMYCIN PHOSPHATE
ANDA #208767 |
SUPPL-2 |
CLINDAMYCIN PHOSPHATE |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 04/26/2023 |
CLINDAMYCIN PHOSPHATE
ANDA #208767 |
SUPPL-3 |
CLINDAMYCIN PHOSPHATE |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 04/26/2023 |
GEFITINIB
ANDA #208913 |
ORIG-1 |
GEFITINIB |
ACTAVIS LABS FL INC |
|
Approval |
| 04/26/2023 |
ISOPROTERENOL HYDROCHLORIDE
ANDA #211703 |
ORIG-1 |
ISOPROTERENOL HYDROCHLORIDE |
HIKMA |
|
Approval |
| 04/26/2023 |
TRIKAFTA (COPACKAGED)
NDA #212273 |
SUPPL-9 |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
VERTEX PHARMS INC |
Labeling |
Approval |
| 04/26/2023 |
CLOBAZAM
ANDA #213039 |
SUPPL-4 |
CLOBAZAM |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/26/2023 |
CLOBAZAM
ANDA #214404 |
SUPPL-1 |
CLOBAZAM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/26/2023 |
ZEJULA
NDA #214876 |
ORIG-1 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Type 3 - New Dosage Form |
Approval |
| 04/26/2023 |
LIVTENCITY
NDA #215596 |
SUPPL-4 |
MARIBAVIR |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/26/2023 |
PREGABALIN
ANDA #215755 |
ORIG-1 |
PREGABALIN |
ACI |
|
Approval |
| 04/26/2023 |
THEOPHYLLINE
ANDA #216300 |
ORIG-1 |
THEOPHYLLINE |
BIONPHARMA |
|
Approval |
| 04/26/2023 |
DEXAMETHASONE
ANDA #217538 |
ORIG-1 |
DEXAMETHASONE |
BIONPHARMA |
|
Approval |
| 04/26/2023 |
TRIKAFTA (COPACKAGED)
NDA #217660 |
ORIG-1 |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
VERTEX PHARMS INC |
Type 3 - New Dosage Form |
Approval |
| 04/26/2023 |
HADLIMA
BLA #761059 |
SUPPL-13 |
ADALIMUMAB-BWWD |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
| 04/27/2023 |
DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #090081 |
SUPPL-15 |
DROSPIRENONE; ETHINYL ESTRADIOL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/27/2023 |
DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #090081 |
SUPPL-20 |
DROSPIRENONE; ETHINYL ESTRADIOL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/27/2023 |
DRONEDARONE
ANDA #210678 |
ORIG-1 |
DRONEDARONE |
AUROBINDO PHARMA LTD |
|
Tentative Approval |
| 04/27/2023 |
OLOPATADINE HYDROCHLORIDE
ANDA #210901 |
SUPPL-4 |
OLOPATADINE HYDROCHLORIDE |
AMNEAL |
Labeling |
Approval |
| 04/27/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #211977 |
SUPPL-1 |
ESOMEPRAZOLE MAGNESIUM |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/27/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #211977 |
SUPPL-8 |
ESOMEPRAZOLE MAGNESIUM |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/27/2023 |
THALIDOMIDE
ANDA #213267 |
ORIG-1 |
THALIDOMIDE |
NATCO |
|
Approval |
| 04/27/2023 |
THALIDOMIDE
ANDA #213267 |
ORIG-2 |
THALIDOMIDE |
NATCO |
|
Tentative Approval |
| 04/27/2023 |
CHLORZOXAZONE
ANDA #214365 |
ORIG-1 |
CHLORZOXAZONE |
ACME LABS |
|
Approval |
| 04/27/2023 |
ABILIFY ASIMTUFII
NDA #217006 |
ORIG-1 |
ARIPIPRAZOLE |
OTSUKA |
Type 3 - New Dosage Form |
Approval |
| 04/27/2023 |
GUANFACINE HYDROCHLORIDE
ANDA #217293 |
ORIG-1 |
GUANFACINE HYDROCHLORIDE |
AJANTA PHARMA LTD |
|
Approval |
| 04/27/2023 |
DOXYCYCLINE
ANDA #217674 |
ORIG-1 |
DOXYCYCLINE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 04/28/2023 |
VIMPAT
NDA #022253 |
SUPPL-50 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
| 04/28/2023 |
VIMPAT
NDA #022254 |
SUPPL-40 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
| 04/28/2023 |
VIMPAT
NDA #022255 |
SUPPL-32 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
| 04/28/2023 |
VORICONAZOLE
ANDA #090862 |
SUPPL-15 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
| 04/28/2023 |
VORICONAZOLE
ANDA #090862 |
SUPPL-16 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
| 04/28/2023 |
VORICONAZOLE
ANDA #090862 |
SUPPL-19 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
| 04/28/2023 |
VORICONAZOLE
ANDA #090862 |
SUPPL-21 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
| 04/28/2023 |
RISEDRONATE SODIUM
ANDA #090886 |
SUPPL-7 |
RISEDRONATE SODIUM |
SUN PHARM |
Labeling |
Approval |
| 04/28/2023 |
ABACAVIR SULFATE
ANDA #091050 |
SUPPL-10 |
ABACAVIR SULFATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/28/2023 |
ABACAVIR SULFATE
ANDA #091050 |
SUPPL-11 |
ABACAVIR SULFATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/28/2023 |
ABACAVIR SULFATE
ANDA #091050 |
SUPPL-12 |
ABACAVIR SULFATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/28/2023 |
NITROFURANTOIN
ANDA #201679 |
SUPPL-10 |
NITROFURANTOIN |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/28/2023 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #204104 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
MYLAN LABS LTD |
|
Approval |
| 04/28/2023 |
OMEPRAZOLE MAGNESIUM
ANDA #213201 |
ORIG-1 |
OMEPRAZOLE MAGNESIUM |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/28/2023 |
UZEDY
NDA #213586 |
ORIG-1 |
RISPERIDONE |
TEVA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/28/2023 |
DEFERASIROX
ANDA #214559 |
SUPPL-3 |
DEFERASIROX |
AUCTA |
Labeling |
Approval |
| 04/28/2023 |
VEKLURY
NDA #214787 |
SUPPL-22 |
REMDESIVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 04/28/2023 |
LIQREV
NDA #214952 |
ORIG-1 |
SILDENAFIL CITRATE |
CMP DEV LLC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/28/2023 |
DOLUTEGRAVIR
NDA #215319 |
ORIG-1 |
DOLUTEGRAVIR |
LAURUS GENERICS INC |
Type 5 - New Formulation or New Manufacturer |
Tentative Approval |
| 04/28/2023 |
VIGABATRIN
ANDA #215519 |
ORIG-1 |
VIGABATRIN |
PROPEL PHARMA |
|
Approval |
| 04/28/2023 |
SYMBICORT AEROSPHERE
NDA #216579 |
ORIG-1 |
BUDESONIDE; FORMOTEROL FUMARATE |
ASTRAZENECA |
Efficacy |
Approval |
| 04/28/2023 |
ESTRADIOL VALERATE
ANDA #216656 |
ORIG-1 |
ESTRADIOL VALERATE |
XIROMED |
|
Approval |
| 04/28/2023 |
LIBTAYO
BLA #761097 |
SUPPL-15 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
| 04/28/2023 |
LIBTAYO
BLA #761097 |
SUPPL-16 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
| 04/28/2023 |
SOGROYA
BLA #761156 |
SUPPL-5 |
SOMAPACITAN-BECO |
NOVO NORDISK INC |
|
Approval |
