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pharmadog

Week of Dec 15, 2025

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 15, 2025approval258d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2025approval258d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

Sponsor: WATSON LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 15, 2025approval258d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →CLARISCAN →fda approvals ↗

Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →CLARISCAN →fda approvals ↗

Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →CLARISCAN →fda approvals ↗

Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →CLARISCAN →fda approvals ↗

Dec 15, 2025approval258d agoNILOTINIB — FDA approvalNILOTINIB

Sponsor: TORRENT. Form: CAPSULE

full page →NILOTINIB →fda approvals ↗

Dec 15, 2025approval258d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2025approval258d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

full page →trastuzumab deruxtecan →fda approvals ↗

Dec 15, 2025approval258d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

full page →trastuzumab deruxtecan →fda approvals ↗

Dec 15, 2025approval258d agoPEMETREXED DISODIUM — FDA approvalAlimta

Sponsor: SANDOZ. Form: SOLUTION. Route: INTRAVENOUS

full page →Alimta →fda approvals ↗

Dec 15, 2025approval258d agoSULFAMETHOPRIM-DS (SULFAMETHOXAZOLE) — FDA approval

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

full page →fda approvals ↗

Dec 15, 2025approval258d agoSULFAMETHOPRIM-DS (SULFAMETHOXAZOLE) — FDA approval

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

full page →fda approvals ↗

Dec 16, 2025approval257d agoTIZANIDINE HYDROCHLORIDE — FDA approvalTIZANIDINE HYDROCHLORIDE

Sponsor: APOTEX INC. Form: CAPSULE. Route: ORAL

full page →TIZANIDINE HYDROCHLORIDE →fda approvals ↗

Dec 16, 2025approval257d agoHYMPAVZI (MARSTACIMAB-HNCQ) — FDA approvalmarstacimab

Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →marstacimab →fda approvals ↗

Dec 16, 2025approval257d agoEXDENSUR (DEPEMOKIMAB-ULAA) — FDA approvaldepemokimab

Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTION

full page →depemokimab →fda approvals ↗

Dec 16, 2025approval257d agoHYDROXYZINE HYDROCHLORIDE — FDA approvalHYDROXYZINE HYDROCHLORIDE

Sponsor: NOVITIUM PHARMA. Form: SYRUP. Route: ORAL

full page →HYDROXYZINE HYDROCHLORIDE →fda approvals ↗

Dec 16, 2025approval257d agoFLUTICASONE PROPIONATE — FDA approvalFluticasone Propionate Glenmark

Sponsor: AUROBINDO PHARMA LTD. Form: SPRAY, METERED. Route: NASAL

full page →Fluticasone Propionate Glenmark →fda approvals ↗

Dec 16, 2025approval257d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 16, 2025approval257d agoCARIPRAZINE HYDROCHLORIDE — FDA approvalCARIPRAZINE HYDROCHLORIDE

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

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗

Dec 16, 2025approval257d agoVYBRIQUE (SILDENAFIL CITRATE) — FDA approvalRevatio

Sponsor: IBSA. Form: FILM. Route: ORAL

full page →Revatio →fda approvals ↗

Dec 16, 2025approval257d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Dec 16, 2025approval257d agoBECLOMETHASONE DIPROPIONATE — FDA approvalSOLIGENIX, INC.

Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION

full page →fda approvals ↗

Dec 16, 2025approval257d agoLOSARTAN POTASSIUM — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 17, 2025approval256d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →eplontersen sodium →fda approvals ↗

Dec 17, 2025approval256d agoZYNYZ (RETIFANLIMAB-DLWR) — FDA approvalretifanlimab

Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS

full page →retifanlimab →fda approvals ↗

Dec 17, 2025approval256d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

full page →fda approvals ↗

Dec 17, 2025approval256d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Dec 17, 2025approval256d agoGAZYVA (OBINUTUZUMAB) — FDA approvalobinutuzumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →obinutuzumab →fda approvals ↗

Dec 17, 2025approval256d agoBORTEZOMIB — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: SHUANGCHENG. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →fda approvals ↗

Dec 17, 2025approval256d agoLATANOPROST — FDA approvalXalatan

Sponsor: MANKIND PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Dec 17, 2025approval256d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →VINCRISTINE SULFATE PFS →fda approvals ↗

Dec 17, 2025approval256d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 17, 2025approval256d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗

Dec 17, 2025approval256d agoRYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ) — FDA approval(amivantamab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTION

full page →(amivantamab + hyaluronidase (human recombinant)) →fda approvals ↗

Dec 17, 2025approval256d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

full page →rucaparib camsylate →fda approvals ↗

Dec 17, 2025approval256d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

full page →rucaparib camsylate →fda approvals ↗

Dec 17, 2025approval256d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalBayer HealthCare Pharmaceuticals Inc

Sponsor: UNIQUE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 17, 2025approval256d agoTESTOSTERONE — FDA approvalTransdermal Delivery Solutions Corp

Sponsor: ENCUBE. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 17, 2025approval256d agoORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE) — FDA approvalORIAHNN (COPACKAGED)

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →ORIAHNN (COPACKAGED) →fda approvals ↗

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Week of Dec 15, 2025