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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 2026

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on February 13, 2026.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/02/2026 PRIMAQUINE
NDA #008316		 SUPPL-26 PRIMAQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
02/02/2026 CONCERTA
NDA #021121		 SUPPL-34 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
02/02/2026 CONCERTA
NDA #021121		 SUPPL-40 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
02/02/2026 CONCERTA
NDA #021121		 SUPPL-45 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
02/02/2026 PUR-WASH
NDA #022305		 SUPPL-8 PURIFIED WATER NIAGARA PHARMS Labeling Approval
02/02/2026 DAPAGLIFLOZIN
ANDA #211582		 ORIG-1 DAPAGLIFLOZIN ZYDUS PHARMS Tentative Approval
02/02/2026 LENALIDOMIDE
ANDA #213165		 ORIG-1 LENALIDOMIDE CIPLA Approval
02/02/2026 PREGABALIN
ANDA #213313		 SUPPL-2 PREGABALIN APOTEX Labeling Approval
02/02/2026 PREGABALIN
ANDA #214322		 SUPPL-6 PREGABALIN CHANGZHOU PHARM Labeling Approval
02/02/2026 NORLIQVA
NDA #214439		 SUPPL-1 AMLODIPINE BESYLATE CMP DEV LLC Labeling Approval
02/02/2026 ESTRADIOL
ANDA #215096		 ORIG-1 ESTRADIOL LONG GROVE PHARMS Approval
02/02/2026 METHYLENE BLUE
ANDA #215636		 SUPPL-4 METHYLENE BLUE ZYDUS LIFESCIENCES Manufacturing (CMC) Approval
02/02/2026 ERDAFITINIB
ANDA #218578		 ORIG-1 ERDAFITINIB NATCO PHARMA LTD Tentative Approval
02/02/2026 ENZALUTAMIDE
ANDA #218731		 ORIG-1 ENZALUTAMIDE HIKMA PHARMACEUTICALS USA INC Tentative Approval
02/02/2026 FIDAXOMICIN
ANDA #219559		 ORIG-1 FIDAXOMICIN APOTEX Approval
02/02/2026 MIRTAZAPINE
ANDA #219919		 ORIG-1 MIRTAZAPINE NOVITIUM PHARMA Approval
02/02/2026 TYRUKO
BLA #761322		 SUPPL-7 NATALIZUMAB-SZTN SANDOZ INC Approval
02/03/2026 EXIDINE
NDA #019125		 SUPPL-48 CHLORHEXIDINE GLUCONATE XTTRIUM Manufacturing (CMC) Approval
02/03/2026 EXIDINE
NDA #019422		 SUPPL-55 CHLORHEXIDINE GLUCONATE XTTRIUM Labeling Approval
02/03/2026 FOSAMAX
NDA #020560		 SUPPL-73 ALENDRONATE SODIUM ORGANON Labeling Approval
02/03/2026 ACTONEL
NDA #020835		 SUPPL-54 RISEDRONATE SODIUM APIL Labeling Approval
02/03/2026 FOSAMAX PLUS D
NDA #021762		 SUPPL-27 ALENDRONATE SODIUM; CHOLECALCIFEROL ORGANON LLC Labeling Approval
02/03/2026 RECLAST
NDA #021817		 SUPPL-32 ZOLEDRONIC ACID SANDOZ Labeling Approval
02/03/2026 ATELVIA
NDA #022560		 SUPPL-13 RISEDRONATE SODIUM APIL Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #078948		 SUPPL-14 IBANDRONATE SODIUM APOTEX INC Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #078995		 SUPPL-5 IBANDRONATE SODIUM PHARMOBEDIENT Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #078996		 SUPPL-6 IBANDRONATE SODIUM SUN PHARM INDUSTRIES Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #078997		 SUPPL-10 IBANDRONATE SODIUM DR REDDYS LABS LTD Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #078998		 SUPPL-8 IBANDRONATE SODIUM ORBION PHARMS Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #079003		 SUPPL-9 IBANDRONATE SODIUM WATSON LABS TEVA Labeling Approval
02/03/2026 ALENDRONATE SODIUM
ANDA #090520		 SUPPL-8 ALENDRONATE SODIUM HIKMA Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #090853		 SUPPL-14 IBANDRONATE SODIUM SUN PHARM Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #090853		 SUPPL-15 IBANDRONATE SODIUM SUN PHARM Labeling Approval
02/03/2026 BINOSTO
NDA #202344		 SUPPL-22 ALENDRONATE SODIUM RADIUS Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #202671		 SUPPL-9 IBANDRONATE SODIUM PHARMOBEDIENT Labeling Approval
02/03/2026 STIVARGA
NDA #203085		 SUPPL-18 REGORAFENIB BAYER HLTHCARE Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #203987		 SUPPL-11 IBANDRONATE SODIUM AVET LIFESCIENCES Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #204222		 SUPPL-4 IBANDRONATE SODIUM APOTEX Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #204222		 SUPPL-5 IBANDRONATE SODIUM APOTEX Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #204329		 SUPPL-2 IBANDRONATE SODIUM NANG KUANG PHARM CO Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #204502		 SUPPL-9 IBANDRONATE SODIUM AUROBINDO PHARMA Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #205332		 SUPPL-7 IBANDRONATE SODIUM EUGIA PHARMA Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #206058		 SUPPL-7 IBANDRONATE SODIUM ACCORD HLTHCARE Labeling Approval
02/03/2026 IBANDRONATE SODIUM
ANDA #206887		 SUPPL-27 IBANDRONATE SODIUM MACLEODS PHARMS LTD Labeling Approval
02/03/2026 PREGABALIN
ANDA #213226		 SUPPL-5 PREGABALIN MSN Labeling Approval
02/03/2026 ALENDRONATE SODIUM
ANDA #214512		 SUPPL-8 ALENDRONATE SODIUM NOVITIUM PHARMA Labeling Approval
02/03/2026 SELENIOUS ACID
ANDA #219472		 ORIG-1 SELENIOUS ACID KINDOS Approval
02/03/2026 DOXORUBICIN HYDROCHLORIDE
ANDA #219881		 ORIG-1 DOXORUBICIN HYDROCHLORIDE QILU PHARM HAINAN Approval
02/03/2026 VYKOURA
NDA #220406		 ORIG-1 LEUCOVORIN CALCIUM AVYXA HOLDINGS Type 5 - New Formulation or New Manufacturer Approval
02/04/2026 EMPAGLIFLOZIN
ANDA #212283		 ORIG-1 EMPAGLIFLOZIN MANKIND PHARMA Tentative Approval
02/04/2026 ATROPINE SULFATE
NDA #214652		 SUPPL-5 ATROPINE SULFATE ACCORD HLTHCARE Labeling Approval
02/04/2026 NINTEDANIB
ANDA #215123		 ORIG-1 NINTEDANIB EUGIA PHARMA SPECLTS Tentative Approval
02/04/2026 SOLRIAMFETOL
ANDA #218725		 ORIG-1 SOLRIAMFETOL AUROBINDO PHARMA LIMITED Tentative Approval
02/04/2026 CARBOPLATIN
ANDA #219999		 ORIG-1 CARBOPLATIN QILU PHARM HAINAN Approval
02/05/2026 FLUOROURACIL
ANDA #040278		 SUPPL-29 FLUOROURACIL FRESENIUS KABI USA Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #040279		 SUPPL-32 FLUOROURACIL FRESENIUS KABI USA Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #040743		 SUPPL-19 FLUOROURACIL ACCORD HLTHCARE Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #040798		 SUPPL-21 FLUOROURACIL ACCORD HLTHCARE Labeling Approval
02/05/2026 NICOTINE POLACRILEX
ANDA #079216		 SUPPL-15 NICOTINE POLACRILEX P AND L Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #202668		 SUPPL-11 FLUOROURACIL EUGIA PHARMA SPECLTS Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #202669		 SUPPL-11 FLUOROURACIL EUGIA PHARMA SPECLTS Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #203608		 SUPPL-4 FLUOROURACIL SAGENT PHARMS INC Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #203609		 SUPPL-15 FLUOROURACIL SAGENT PHARMS INC Labeling Approval
02/05/2026 AZTREONAM
ANDA #207069		 ORIG-1 AZTREONAM HIKMA Approval
02/05/2026 FLUOROURACIL
ANDA #209219		 SUPPL-5 FLUOROURACIL NOVAST LABS Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #209271		 SUPPL-5 FLUOROURACIL NOVAST LABS Labeling Approval
02/05/2026 BUMETANIDE
ANDA #215362		 ORIG-1 BUMETANIDE MSN Approval
02/05/2026 FLUOROURACIL
ANDA #215699		 SUPPL-5 FLUOROURACIL KINDOS Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #216494		 SUPPL-5 FLUOROURACIL KINDOS Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #217295		 SUPPL-5 FLUOROURACIL ALEMBIC Labeling Approval
02/05/2026 FLUOROURACIL
ANDA #217676		 SUPPL-6 FLUOROURACIL ALEMBIC Labeling Approval
02/05/2026 CARBIDOPA, LEVODOPA AND ENTACAPONE
ANDA #218535		 ORIG-1 CARBIDOPA; ENTACAPONE; LEVODOPA ALEMBIC Approval
02/05/2026 PRUCALOPRIDE SUCCINATE
ANDA #219071		 ORIG-1 PRUCALOPRIDE SUCCINATE TEVA PHARMS INC Approval
02/05/2026 MYQORZO
NDA #219083		 SUPPL-1 AFICAMTEN CYTOKINETICS REMS Approval
02/05/2026 HYDROCORTISONE SODIUM SUCCINATE
ANDA #219856		 ORIG-1 HYDROCORTISONE SODIUM SUCCINATE APOTEX Approval
02/05/2026 ZOLEDRONIC ACID
ANDA #219984		 ORIG-1 ZOLEDRONIC ACID GLAND Approval
02/05/2026 NYSTATIN
ANDA #220367		 ORIG-1 NYSTATIN STERANCO HLTHCARE Approval
02/06/2026 GLYCOPYRROLATE
ANDA #040653		 SUPPL-7 GLYCOPYRROLATE PH HEALTH Labeling Approval
02/06/2026 IDAMYCIN PFS
NDA #050734		 SUPPL-32 IDARUBICIN HYDROCHLORIDE PFIZER Labeling Approval
02/06/2026 IDARUBICIN HYDROCHLORIDE
NDA #050734		 SUPPL-32 IDARUBICIN HYDROCHLORIDE PFIZER Labeling Approval
02/06/2026 DOXYCYCLINE HYCLATE
ANDA #062538		 SUPPL-21 DOXYCYCLINE HYCLATE STRIDES PHARMA INTL Labeling Approval
02/06/2026 DOXYCYCLINE HYCLATE
ANDA #062538		 SUPPL-22 DOXYCYCLINE HYCLATE STRIDES PHARMA INTL Labeling Approval
02/06/2026 ANAGRELIDE HYDROCHLORIDE
ANDA #076530		 SUPPL-9 ANAGRELIDE HYDROCHLORIDE BARR LABS Labeling Approval
02/06/2026 PRAVASTATIN SODIUM
ANDA #077491		 SUPPL-9 PRAVASTATIN SODIUM APNAR PHARMA LP Labeling Approval
02/06/2026 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901		 SUPPL-18 FLUOXETINE HYDROCHLORIDE; OLANZAPINE EPIC PHARMA LLC Labeling Approval
02/06/2026 NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
NDA #214313		 SUPPL-8 NOREPINEPHRINE BITARTRATE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/06/2026 TICAGRELOR
ANDA #217679		 ORIG-1 TICAGRELOR MANKIND PHARMA Approval
02/06/2026 LATANOPROSTENE BUNOD
ANDA #219305		 ORIG-1 LATANOPROSTENE BUNOD MICRO LABS LTD Tentative Approval
02/09/2026 REGLAN
NDA #017854		 SUPPL-71 METOCLOPRAMIDE HYDROCHLORIDE ANI PHARMS Labeling Approval
02/09/2026 REGLAN
NDA #017862		 SUPPL-64 METOCLOPRAMIDE HYDROCHLORIDE HIKMA Labeling Approval
02/09/2026 ABSORICA
NDA #021951		 SUPPL-28 ISOTRETINOIN SUN PHARM INDS INC REMS Approval
02/09/2026 DIGOXIN
ANDA #040282		 SUPPL-26 DIGOXIN RISING Labeling Approval
02/09/2026 TRAZODONE HYDROCHLORIDE
ANDA #071196		 SUPPL-83 TRAZODONE HYDROCHLORIDE APOTEX INC Labeling Approval
02/09/2026 TRAZODONE HYDROCHLORIDE
ANDA #071258		 SUPPL-52 TRAZODONE HYDROCHLORIDE APOTEX Labeling Approval
02/09/2026 AMNESTEEM
ANDA #075945		 SUPPL-49 ISOTRETINOIN MYLAN PHARMS INC REMS Approval
02/09/2026 OLANZAPINE
ANDA #076133		 SUPPL-20 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
02/09/2026 CLARAVIS
ANDA #076135		 SUPPL-62 ISOTRETINOIN TEVA PHARMS USA REMS Approval
02/09/2026 OLANZAPINE
ANDA #076255		 SUPPL-18 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
02/09/2026 CLARAVIS
ANDA #076356		 SUPPL-57 ISOTRETINOIN TEVA PHARMS USA REMS Approval
02/09/2026 MYORISAN
ANDA #076485		 SUPPL-41 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
02/09/2026 DIGOXIN
ANDA #078556		 SUPPL-26 DIGOXIN IMPAX LABS Labeling Approval
02/09/2026 SCOPOLAMINE
ANDA #078830		 SUPPL-16 SCOPOLAMINE PADAGIS US Labeling Approval
02/09/2026 SCOPOLAMINE
ANDA #078830		 SUPPL-21 SCOPOLAMINE PADAGIS US Labeling Approval
02/09/2026 ZENATANE
ANDA #202099		 SUPPL-39 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
02/09/2026 ISOTRETINOIN
ANDA #205063		 SUPPL-10 ISOTRETINOIN ACTAVIS LABS FL REMS Approval
02/09/2026 ISOTRETINOIN
ANDA #207792		 SUPPL-30 ISOTRETINOIN AMNEAL PHARMS NY REMS Approval
02/09/2026 GIMOTI
NDA #209388		 SUPPL-4 METOCLOPRAMIDE HYDROCHLORIDE EVOKE PHARMA INC Labeling Approval
02/09/2026 ISOTRETINOIN
ANDA #211568		 SUPPL-4 ISOTRETINOIN ZYDUS PHARMS REMS Approval
02/09/2026 ABSORICA LD
NDA #211913		 SUPPL-13 ISOTRETINOIN SUN PHARM REMS Approval
02/09/2026 ISOTRETINOIN
ANDA #212333		 SUPPL-10 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
02/09/2026 SCOPOLAMINE
ANDA #212342		 SUPPL-3 SCOPOLAMINE RICONPHARMA LLC Labeling Approval
02/09/2026 SCOPOLAMINE
ANDA #212342		 SUPPL-6 SCOPOLAMINE RICONPHARMA LLC Labeling Approval
02/09/2026 SCOPOLAMINE
ANDA #212342		 SUPPL-7 SCOPOLAMINE RICONPHARMA LLC Labeling Approval
02/09/2026 ISOTRETINOIN
ANDA #213571		 SUPPL-9 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
02/09/2026 ISOTRETINOIN
ANDA #216097		 SUPPL-1 ISOTRETINOIN AMNEAL PHARMS NY REMS Approval
02/09/2026 ISOTRETINOIN
ANDA #216633		 SUPPL-1 ISOTRETINOIN ZYDUS PHARMS REMS Approval
02/09/2026 METHAZOLAMIDE
ANDA #217408		 ORIG-1 METHAZOLAMIDE AJANTA PHARMA LTD Approval
02/09/2026 ISOTRETINOIN
ANDA #218194		 SUPPL-1 ISOTRETINOIN AUROBINDO PHARMA REMS Approval
02/09/2026 ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
ANDA #218575		 ORIG-1 ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE APOTEX INC Tentative Approval
02/10/2026 FLUOROURACIL
ANDA #040333		 SUPPL-34 FLUOROURACIL TEVA PHARMS USA Labeling Approval
02/10/2026 FLUOROURACIL
ANDA #040334		 SUPPL-34 FLUOROURACIL TEVA PHARMS USA Labeling Approval
02/10/2026 GLYCOPYRROLATE
ANDA #040821		 SUPPL-14 GLYCOPYRROLATE RISING Labeling Approval
02/10/2026 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #073303		 SUPPL-46 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA PHARMS USA Labeling Approval
02/10/2026 KEYTRUDA
BLA #125514		 SUPPL-186 PEMBROLIZUMAB MERCK SHARP DOHME Approval
02/10/2026 TAPENTADOL HYDROCHLORIDE
ANDA #205057		 ORIG-1 TAPENTADOL HYDROCHLORIDE HIKMA Approval
02/10/2026 EVRYSDI
NDA #213535		 SUPPL-17 RISDIPLAM GENENTECH INC Labeling Approval
02/10/2026 MIGALASTAT
ANDA #217786		 ORIG-1 MIGALASTAT HYDROCHLORIDE AUROBINDO PHARMA LIMITED Tentative Approval
02/10/2026 TRETINOIN
ANDA #217833		 ORIG-1 TRETINOIN ENCUBE Approval
02/10/2026 EVRYSDI
NDA #219285		 SUPPL-2 RISDIPLAM GENENTECH INC Labeling Approval
02/10/2026 FLUDROCORTISONE ACETATE
ANDA #220308		 ORIG-1 FLUDROCORTISONE ACETATE HIBROW HLTHCARE Approval
02/10/2026 KEYTRUDA QLEX
BLA #761467		 SUPPL-2 PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH MERCK SHARP DOHME Approval
02/11/2026 AUBAGIO
NDA #202992		 SUPPL-18 TERIFLUNOMIDE SANOFI AVENTIS US Labeling Approval
02/11/2026 NARCAN
NDA #208411		 SUPPL-11 NALOXONE HYDROCHLORIDE EMERGENT Labeling Approval
02/11/2026 CAMCEVI KIT
NDA #211488		 SUPPL-11 LEUPROLIDE MESYLATE ACCORD Labeling Approval
02/11/2026 GLATIRAMER ACETATE
ANDA #213382		 ORIG-1 GLATIRAMER ACETATE HYBIO Approval
02/11/2026 GLATIRAMER ACETATE
ANDA #214022		 ORIG-1 GLATIRAMER ACETATE HYBIO Approval
02/11/2026 BRIMONIDINE TARTRATE
ANDA #216361		 SUPPL-2 BRIMONIDINE TARTRATE DR REDDYS LABS SA Labeling Approval
02/11/2026 PAXLOVID (COPACKAGED)
NDA #217188		 SUPPL-16 NIRMATRELVIR; RITONAVIR PFIZER Labeling Approval
02/11/2026 PAXLOVID (COPACKAGED)
NDA #217188		 SUPPL-17 NIRMATRELVIR; RITONAVIR PFIZER Labeling Approval
02/12/2026 PROMETRIUM
NDA #019781		 SUPPL-26 PROGESTERONE ACERTIS PHARMS Labeling Approval
02/12/2026 PEPCID AC
NDA #020325		 SUPPL-45 FAMOTIDINE KENVUE BRANDS Labeling Approval
02/12/2026 ESTRING
NDA #020472		 SUPPL-22 ESTRADIOL PFIZER Labeling Approval
02/12/2026 CENESTIN
NDA #020992		 SUPPL-43 ESTROGENS, CONJUGATED SYNTHETIC A ASPEN Labeling Approval
02/12/2026 ENJUVIA
NDA #021443		 SUPPL-14 ESTROGENS, CONJUGATED SYNTHETIC B ASPEN Labeling Approval
02/12/2026 DIVIGEL
NDA #022038		 SUPPL-17 ESTRADIOL VERTICAL PHARMS Labeling Approval
02/12/2026 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-106 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
02/12/2026 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-90 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
02/12/2026 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-44 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
02/12/2026 GABAPENTIN
ANDA #090858		 SUPPL-42 GABAPENTIN ALKEM Labeling Approval
02/12/2026 TRAMADOL HYDROCHLORIDE
ANDA #202075		 SUPPL-7 TRAMADOL HYDROCHLORIDE STRIDES PHARMA Manufacturing (CMC) Approval
02/12/2026 CELECOXIB
ANDA #208856		 SUPPL-3 CELECOXIB QINGDAO BAHEAL PHARM Labeling Approval
02/12/2026 BIJUVA
NDA #210132		 SUPPL-13 ESTRADIOL; PROGESTERONE MAYNE PHARMA Labeling Approval
02/12/2026 LEQVIO
NDA #214012		 SUPPL-17 INCLISIRAN SODIUM NOVARTIS Efficacy Approval
02/12/2026 LEQVIO
NDA #214012		 SUPPL-18 INCLISIRAN SODIUM NOVARTIS Efficacy Approval
02/12/2026 FLUOROMETHOLONE
ANDA #218819		 ORIG-1 FLUOROMETHOLONE DIFGEN PHARMS Approval
02/12/2026 ADQUEY
NDA #219474		 ORIG-1 DIFAMILAST ACROTECH BIOPHARMA Type 1 - New Molecular Entity Approval
02/12/2026 DARZALEX FASPRO
BLA #761145		 SUPPL-39 DARATUMUMAB AND HYALURONIDASE-FIHJ JANSSEN BIOTECH Approval
02/12/2026 ENZEEVU
BLA #761382		 SUPPL-8 AFLIBERCEPT-ABZV SANDOZ INC Approval
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