Calendar

pharmadog

Week of Sep 29, 2025

Oct 1, 2025approval317d agoVONJO (PACRITINIB CITRATE) — FDA approvalpacritinib

Sponsor: SOBI. Form: CAPSULE. Route: ORAL

full page →pacritinib →fda approvals ↗

Oct 1, 2025approval317d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Oct 1, 2025approval317d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 1, 2025approval317d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

full page →fda approvals ↗

Oct 1, 2025approval317d 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, 2025approval317d 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, 2025approval317d 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, 2025approval317d agoFLUOCINOLONE ACETONIDE — FDA approvalEclipse Life Sciences Inc

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoFLUOCINOLONE ACETONIDE — FDA approvalEclipse Life Sciences Inc

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoDORZOLAMIDE HYDROCHLORIDE — FDA approvalDORZOLAMIDE HYDROCHLORIDE

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

full page →DORZOLAMIDE HYDROCHLORIDE →fda approvals ↗

Oct 1, 2025approval317d agoDORZOLAMIDE HYDROCHLORIDE — FDA approvalDORZOLAMIDE HYDROCHLORIDE

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

full page →DORZOLAMIDE HYDROCHLORIDE →fda approvals ↗

Oct 1, 2025approval317d agoDIAMOX (ACETAZOLAMIDE) — FDA approvalAccord Healthcare Inc

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoPREDNISONE — FDA approvalVintage Pharmaceuticals Inc (Inactive)

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Oct 1, 2025approval317d agoLETROZOLE — FDA approvalLETROZOLE

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

full page →LETROZOLE →fda approvals ↗

Oct 1, 2025approval317d agoLETROZOLE — FDA approvalLETROZOLE

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

full page →LETROZOLE →fda approvals ↗

Oct 1, 2025approval317d agoMEROPENEM — FDA approvalMEROPENEM

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

full page →MEROPENEM →fda approvals ↗

Oct 1, 2025approval317d agoMEROPENEM — FDA approvalMEROPENEM

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

full page →MEROPENEM →fda approvals ↗

Oct 1, 2025approval317d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 1, 2025approval317d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 1, 2025approval317d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 1, 2025approval317d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

full page →FENOFIBRATE →fda approvals ↗

Oct 1, 2025approval317d agoPREGABALIN — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoPREGABALIN — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoPREGABALIN — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 1, 2025approval317d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗

Oct 1, 2025approval317d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

Oct 1, 2025approval317d agoMIUDELLA (COPPER) — FDA approval

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

full page →fda approvals ↗

Oct 2, 2025approval316d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗

Oct 2, 2025approval316d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

full page →talquetamab →fda approvals ↗

Oct 2, 2025approval316d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

full page →lurbinectedin →fda approvals ↗

Oct 2, 2025approval316d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

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

full page →fda approvals ↗

Oct 2, 2025approval316d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Oct 2, 2025approval316d 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, 2025approval316d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

Oct 2, 2025approval316d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

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

full page →METHYLIN ER →fda approvals ↗

Oct 2, 2025approval316d agoCROMOLYN SODIUM — FDA approvalVitalgenics LLC

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

full page →fda approvals ↗

Oct 2, 2025approval316d 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, 2025approval316d 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, 2025approval316d agoEYDENZELT (AFLIBERCEPT-BOAV) — FDA approvalEYDENZELT

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

full page →EYDENZELT →fda approvals ↗

Oct 2, 2025approval316d agoSEVOFLURANE — FDA approvalSEVOFLURANE

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

full page →SEVOFLURANE →fda approvals ↗

Oct 2, 2025approval316d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval316d agoVANCOMYCIN HYDROCHLORIDE — FDA approvalSamson Medical Technologies LLC

Sponsor: STERISCIENCE. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 2, 2025approval316d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 2, 2025approval316d agoPILOCARPINE HYDROCHLORIDE — FDA approvalPILOCARPINE HYDROCHLORIDE

Sponsor: FDC LTD. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →PILOCARPINE HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval316d agoOSELTAMIVIR PHOSPHATE — FDA approvalF. Hoffmann-La Roche Ltd

Sponsor: ZHEJIANG POLY PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval316d agoMIRTAZAPINE — FDA approvalmirtazapine ODT

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

full page →mirtazapine ODT →fda approvals ↗

Oct 2, 2025approval316d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval316d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

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Week of Sep 29, 2025