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Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 — Reason: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2026approval164d agoDUOPA (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ABBVIE. Form: SUSPENSION. Route: ENTERAL

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval164d agoRIFAXIMIN — FDA approvalSalix Pharmaceuticals Ltd

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval164d agoRIFABUTIN — FDA approvali3 Pharmaceuticals LLC

Sponsor: I3 PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval164d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval164d agoVYALEV (FOSCARBIDOPA) — FDA approval(foscarbidopa + foslevodopa)

Sponsor: ABBVIE. Form: SOLUTION. Route: SUBCUTANEOUS

full page →(foscarbidopa + foslevodopa) →fda approvals ↗

Mar 19, 2026approval164d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval164d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →OPUVIZ →fda approvals ↗

Mar 19, 2026approval164d agoVALGANCICLOVIR HYDROCHLORIDE — FDA approvalVALGANCICLOVIR HYDROCHLORIDE

Sponsor: MICRO LABS. Form: FOR SOLUTION. Route: ORAL

full page →VALGANCICLOVIR HYDROCHLORIDE →fda approvals ↗

Mar 19, 2026approval164d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Mar 19, 2026approval164d agoFLAVALTA (EPINEPHRINE BITARTRATE) — FDA approvalDe Motu Cordis Pty Ltd

Sponsor: DEPROCO. Form: SOLUTION. Route: INJECTION

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Mar 19, 2026approval164d agoDHIVY (CARBIDOPA) — FDA approvalAvion Pharmaceuticals LLC

Sponsor: AVION PHARMS. Form: TABLET. Route: ORAL

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Mar 19, 2026approval164d agoRYTARY (CARBIDOPA) — FDA approvalOrganon & Co.

Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval164d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval164d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval164d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval164d agoSINEMET CR (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ORGANON LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval164d agoCREXONT (CARBIDOPA) — FDA approvalOrganon & Co.

Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval164d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

full page →setmelanotide →fda approvals ↗

Mar 19, 2026approval164d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

full page →fda approvals ↗

Mar 19, 2026approval164d agoSINEMET (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ORGANON. Form: TABLET. Route: ORAL

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval164d agoEPHEDRINE SULFATE — FDA approvalEPHEDRINE SULFATE

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INTRAVENOUS

full page →EPHEDRINE SULFATE →fda approvals ↗

Mar 19, 2026approval164d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

Sponsor: VIWIT PHARM. Form: INJECTABLE. Route: INJECTION

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Mar 20, 2026approval163d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 20, 2026approval163d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2026approval163d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2026approval163d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 20, 2026approval163d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗

Mar 20, 2026approval163d agoATONCY (ATOMOXETINE HYDROCHLORIDE) — FDA approvalPrasco LLC

Sponsor: MAP77. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 20, 2026approval163d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

Mar 20, 2026approval163d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

Sponsor: GLAXOSMITHKLINE LLC. Form: SUSPENSION. Route: ORAL

full page →atovaquone →fda approvals ↗

Mar 20, 2026approval163d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Mar 20, 2026approval163d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

Mar 20, 2026approval163d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →adrenaline →fda approvals ↗

Mar 20, 2026approval163d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Mar 20, 2026approval163d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Mar 20, 2026approval163d agoLIDOCAINE HYDROCHLORIDE — FDA approvalLaryng-O-Jet

Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

full page →Laryng-O-Jet →fda approvals ↗

Week of Mar 23, 2026

Mar 23, 2026approval160d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 23, 2026approval

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Week of Mar 23, 2026