Calendar

pharmadog

Week of Sep 29, 2025

Sep 30, 2025approval333d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Sep 30, 2025approval333d agoTAMSULOSIN HYDROCHLORIDE — FDA approvalSynthon Pharmaceuticals Inc (Inactive)

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 30, 2025approval333d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

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

full page →ropinirole hydrochloride ER →fda approvals ↗

Sep 30, 2025approval333d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Sep 30, 2025approval333d agoNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE) — FDA approvalET-800

Sponsor: AMNEAL. Form: SUSPENSION/DROPS. Route: OTIC

full page →ET-800 →fda approvals ↗

Sep 30, 2025approval333d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: SINOTHERAPEUTICS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Oct 1, 2025approval332d agoVONJO (PACRITINIB CITRATE) — FDA approvalpacritinib

Sponsor: SOBI. Form: CAPSULE. Route: ORAL

full page →pacritinib →fda approvals ↗

Oct 1, 2025approval332d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →Kapanol →fda approvals ↗

Oct 1, 2025approval332d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: PADAGIS US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 1, 2025approval332d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 1, 2025approval332d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 1, 2025approval332d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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

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

Oct 1, 2025approval332d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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

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

Oct 1, 2025approval332d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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

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

Oct 1, 2025approval332d agoFLUOCINOLONE ACETONIDE — FDA approvalEclipse Life Sciences Inc

Sponsor: PADAGIS ISRAEL. Form: OIL. Route: TOPICAL

full page →fda approvals ↗

Oct 1, 2025approval332d agoFLUOCINOLONE ACETONIDE — FDA approvalEclipse Life Sciences Inc

Sponsor: PADAGIS ISRAEL. Form: OIL/DROPS. Route: OTIC

full page →fda approvals ↗

Oct 1, 2025approval332d agoDORZOLAMIDE HYDROCHLORIDE — FDA approvalDORZOLAMIDE HYDROCHLORIDE

Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →DORZOLAMIDE HYDROCHLORIDE →fda approvals ↗

Oct 1, 2025approval332d agoDORZOLAMIDE HYDROCHLORIDE — FDA approvalDORZOLAMIDE HYDROCHLORIDE

Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →DORZOLAMIDE HYDROCHLORIDE →fda approvals ↗

Oct 1, 2025approval332d agoDIAMOX (ACETAZOLAMIDE) — FDA approvalAccord Healthcare Inc

Sponsor: TEVA BRANDED PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 1, 2025approval332d agoPREDNISONE — FDA approvalVintage Pharmaceuticals Inc (Inactive)

Sponsor: DR REDDYS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 1, 2025approval332d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ANNORA PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Oct 1, 2025approval332d agoLETROZOLE — FDA approvalLETROZOLE

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

full page →LETROZOLE →fda approvals ↗

Oct 1, 2025approval332d agoLETROZOLE — FDA approvalLETROZOLE

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

full page →LETROZOLE →fda approvals ↗

Oct 1, 2025approval332d agoMEROPENEM — FDA approvalMEROPENEM

Sponsor: ACS DOBFAR SPA. Form: INJECTABLE. Route: INJECTION

full page →MEROPENEM →fda approvals ↗

Oct 1, 2025approval332d agoMEROPENEM — FDA approvalMEROPENEM

Sponsor: ACS DOBFAR SPA. Form: INJECTABLE. Route: INJECTION

full page →MEROPENEM →fda approvals ↗

Oct 1, 2025approval332d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 1, 2025approval332d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 1, 2025approval332d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 1, 2025approval332d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

full page →FENOFIBRATE →fda approvals ↗

Oct 1, 2025approval332d agoPREGABALIN — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 1, 2025approval332d agoPREGABALIN — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 1, 2025approval332d agoPREGABALIN — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 1, 2025approval332d agoDOXYCYCLINE — FDA approvaldoxycycline ER

Sponsor: AIPING PHARM INC. Form: CAPSULE. Route: ORAL

full page →doxycycline ER →fda approvals ↗

Oct 1, 2025approval332d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗

Oct 1, 2025approval332d agoMIUDELLA (COPPER) — FDA approval

Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE

full page →fda approvals ↗

Oct 2, 2025approval331d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →teclistamab →fda approvals ↗

Oct 2, 2025approval331d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →talquetamab →fda approvals ↗

Oct 2, 2025approval331d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

full page →lurbinectedin →fda approvals ↗

Oct 2, 2025approval331d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 2, 2025approval331d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Oct 2, 2025approval331d agoTECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) — FDA approval(atezolizumab + hyaluronidase (human recombinant))

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

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

Oct 2, 2025approval331d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

full page →atezolizumab →fda approvals ↗

Oct 2, 2025approval331d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

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

full page →METHYLIN ER →fda approvals ↗

Oct 2, 2025approval331d agoCROMOLYN SODIUM — FDA approvalVitalgenics LLC

Sponsor: TEVA PHARMS. Form: SOLUTION. Route: INHALATION

full page →fda approvals ↗

Oct 2, 2025approval331d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

Oct 2, 2025approval331d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

Oct 2, 2025approval331d agoEYDENZELT (AFLIBERCEPT-BOAV) — FDA approvalEYDENZELT

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

full page →EYDENZELT →fda approvals ↗

Oct 2, 2025approval331d agoSEVOFLURANE — FDA approvalSEVOFLURANE

Sponsor: BAXTER HLTHCARE. Form: LIQUID. Route: INHALATION

full page →SEVOFLURANE →fda approvals ↗

Oct 2, 2025approval331d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval331d agoVANCOMYCIN HYDROCHLORIDE — FDA approvalSamson Medical Technologies LLC

Sponsor: STERISCIENCE. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

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Week of Sep 29, 2025