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Week of Jan 5, 2026

50

Jan 6, 2026approval218d agoOLOPATADINE HYDROCHLORIDE — FDA approvalPataday

Sponsor: GLAND. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Pataday →fda approvals ↗

Jan 6, 2026approval218d agoCIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN) — FDA approvalBedford Laboratories

Sponsor: UPSHER SMITH LABS. Form: SUSPENSION/DROPS. Route: OTIC

full page →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 6, 2026approval218d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: STRIDES PHARMA INTL. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Jan 6, 2026approval218d agoMECLIZINE HYDROCHLORIDE — FDA approvalMECLIZINE HYDROCHLORIDE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →MECLIZINE HYDROCHLORIDE →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 6, 2026approval218d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 6, 2026approval218d agoAMONDYS 45 (CASIMERSEN) — FDA approvalcasimersen

Sponsor: SAREPTA THERAPS INC. Form: SOLUTION. Route: INTRAVENOUS

full page →casimersen →fda approvals ↗

Jan 6, 2026approval218d agoBORTEZOMIB — FDA approvalBortezomib Pfizer

Sponsor: GLAND. Form: POWDER. Route: INTRAVENOUS, SUBCUTANEOUS

full page →Bortezomib Pfizer →fda approvals ↗

Jan 6, 2026approval218d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

Sponsor: KNACK. Form: INJECTABLE. Route: INJECTION

full page →ROCURONIUM BROMIDE →fda approvals ↗

Jan 7, 2026approval217d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Jan 7, 2026approval217d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Jan 7, 2026approval217d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL

full page →quetiapine fumarate ER →fda approvals ↗

Jan 7, 2026approval217d agoENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM) — FDA approvalShenzhen Techdow Pharmaceutical Co Ltd

Sponsor: HEBEI CHANGSHAN. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jan 7, 2026approval217d agoPROTRIPTYLINE HYDROCHLORIDE — FDA approvalPROTRIPTYLINE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →PROTRIPTYLINE HYDROCHLORIDE →fda approvals ↗

Jan 7, 2026approval217d agoYESINTEK (USTEKINUMAB-KFCE) — FDA approvalustekinumab biosimilar

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →ustekinumab biosimilar →fda approvals ↗

Jan 7, 2026approval217d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: HUMANWELL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 7, 2026approval217d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: HUMANWELL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 7, 2026approval217d agoNORGESTIMATE AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: MYLAN. Form: TABLET. Route: ORAL-28

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

Jan 7, 2026approval217d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗

Jan 7, 2026approval217d agoMETOLAZONE — FDA approvalMETOLAZONE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METOLAZONE →fda approvals ↗

Jan 8, 2026approval216d agoENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approvalensartinib hydrochloride

Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL

full page →ensartinib hydrochloride →fda approvals ↗

Jan 8, 2026approval216d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →ACETAZOLAMIDE →fda approvals ↗

Jan 8, 2026approval216d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →ACETAZOLAMIDE →fda approvals ↗

Jan 8, 2026approval216d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

full page →ACETAZOLAMIDE →fda approvals ↗

Jan 8, 2026approval216d agoSAPROPTERIN DIHYDROCHLORIDE — FDA approvalSAPROPTERIN DIHYDROCHLORIDE

Sponsor: MICRO LABS. Form: POWDER. Route: ORAL

full page →SAPROPTERIN DIHYDROCHLORIDE →fda approvals ↗

Jan 8, 2026approval216d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Jan 8, 2026approval216d agoMAGNESIUM SULFATE — FDA approvalMAGNESIUM SULFATE

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION

full page →MAGNESIUM SULFATE →fda approvals ↗

Jan 8, 2026approval216d agoFLUCONAZOLE — FDA approvalDiflucan

Sponsor: FDC LTD. Form: TABLET. Route: ORAL

full page →Diflucan →fda approvals ↗

Jan 8, 2026approval216d agoFUROSEMIDE — FDA approvalFurosemide Sun

Sponsor: MICRO LABS. Form: INJECTABLE. Route: INJECTION

full page →Furosemide Sun →fda approvals ↗

Jan 8, 2026approval216d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 9, 2026approval215d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Jan 9, 2026approval215d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: ABHAI LLC. Form: SOLUTION. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Jan 9, 2026approval215d agoAMITRIPTYLINE HYDROCHLORIDE — FDA approvalAlgoTherapeutix SAS

Sponsor: UNIQUE PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 9, 2026approval215d agoVARENICLINE TARTRATE — FDA approvalMylan Pharmaceuticals Inc

Sponsor: UMEDICA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 9, 2026approval215d agoEVEROLIMUS — FDA approvalEVEROLIMUS

Sponsor: BIOCON PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →EVEROLIMUS →fda approvals ↗

Jan 9, 2026approval215d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Jan 9, 2026approval215d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Jan 9, 2026approval215d agoPHYTONADIONE — FDA approvalSigyn Therapeutics, Inc.

Sponsor: SUNNY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

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