Calendar

pharmadog

Week of Dec 11, 2023

Dec 11, 2023approval976d agoHYDROCODONE BITARTRATE — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

Dec 11, 2023approval976d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 11, 2023approval976d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 11, 2023approval976d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 11, 2023approval976d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 11, 2023approval976d agoFINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approvalfenfluramine hydrochloride

Sponsor: UCB INC. Form: SOLUTION. Route: ORAL

full page →fenfluramine hydrochloride →fda approvals ↗

Dec 12, 2023approval975d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 12, 2023approval975d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 12, 2023approval975d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 12, 2023approval975d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 12, 2023approval975d agoVYVGART (EFGARTIGIMOD ALFA) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 13, 2023approval974d agoELREXFIO (ELRANATAMAB) — FDA approvalelranatamab

Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION

full page →elranatamab →fda approvals ↗

Dec 13, 2023approval974d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

full page →TRAVOPROST →fda approvals ↗

Dec 13, 2023approval974d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Dec 13, 2023approval974d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Dec 13, 2023approval974d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗

Dec 13, 2023approval974d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: GENUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: GENUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 13, 2023approval974d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 13, 2023approval974d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

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

full page →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

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

full page →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 13, 2023approval974d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 13, 2023approval974d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

Dec 14, 2023approval973d agoEYLEA HD (AFLIBERCEPT) — FDA approvalEYLEA HD

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →EYLEA HD →fda approvals ↗

Dec 14, 2023approval973d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 14, 2023approval973d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 14, 2023approval973d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 14, 2023approval973d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 14, 2023approval973d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 14, 2023approval973d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 14, 2023approval973d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 14, 2023approval973d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 14, 2023approval973d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 14, 2023approval973d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION

full page →tralokinumab →fda approvals ↗

Dec 15, 2023approval972d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

Dec 15, 2023approval972d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

Dec 15, 2023approval972d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 15, 2023approval972d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

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Week of Dec 11, 2023