Calendar

pharmadog

Oct 11, 2023approval1057d agoAMPHETAMINE SULFATE — FDA approvalAmneal Pharmaceuticals, Inc.

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

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Oct 12, 2023approval1056d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

Oct 13, 2023approval1055d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Oct 13, 2023approval1055d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

Oct 13, 2023approval1055d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL

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Oct 13, 2023approval1055d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

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Oct 13, 2023approval1055d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

full page →encorafenib →fda approvals ↗

Oct 13, 2023approval1055d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗

Oct 13, 2023approval1055d agoAMPHETAMINE SULFATE — FDA approvalamfetamine ER

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

full page →amfetamine ER →fda approvals ↗

Oct 13, 2023approval1055d agoAMPHETAMINE SULFATE — FDA approvalAurolife Pharma LLC

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

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Oct 13, 2023approval1055d agoJORNAY PM (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: IRONSHORE PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Oct 13, 2023approval1055d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

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

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Oct 13, 2023approval1055d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

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

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Oct 13, 2023approval1055d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

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

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Oct 13, 2023approval1055d agoRELEXXII (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: OSMOTICA PHARM US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Oct 13, 2023approval1055d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

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Oct 13, 2023approval1055d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →METADATE CD →fda approvals ↗

Oct 13, 2023approval1055d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

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Oct 13, 2023approval1055d agoXELSTRYM (DEXTROAMPHETAMINE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL

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Oct 13, 2023approval1055d agoDYANAVEL XR 20 (AMPHETAMINE) — FDA approvalDYANAVEL XR 20

Sponsor: TRIS PHARMA INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →DYANAVEL XR 20 →fda approvals ↗

Oct 13, 2023approval1055d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

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

full page →RITALIN LA →fda approvals ↗

Oct 13, 2023approval1055d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

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

full page →RITALIN LA →fda approvals ↗

Oct 13, 2023approval1055d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Oct 13, 2023approval1055d agoAZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvalSandoz Inc

Sponsor: COMMAVE THERAP. Form: CAPSULE. Route: ORAL

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Oct 13, 2023approval1055d agoAZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvalSandoz Inc

Sponsor: COMMAVE THERAP. Form: CAPSULE. Route: ORAL

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Oct 13, 2023approval1055d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL

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Oct 13, 2023approval1055d agoAPTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: RHODES PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Oct 13, 2023approval1055d agoDYANAVEL XR (AMPHETAMINE) — FDA approvalamfetamine ER

Sponsor: TRIS PHARMA INC. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →amfetamine ER →fda approvals ↗

Oct 13, 2023approval1055d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 13, 2023approval1055d agoCOTEMPLA XR-ODT (METHYLPHENIDATE) — FDA approvalAYTU BIOPHARMA, INC

Sponsor: NEOS THERAPS INC. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Week of Oct 9, 2023

Week of Oct 16, 2023