Calendar

Week of Jan 1, 2024

Jan 3, 2024approval953d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

Sponsor: WEST-WARD PHARMS INT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 3, 2024approval953d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

Sponsor: WEST-WARD PHARMS INT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 3, 2024approval953d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Jan 3, 2024approval953d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Jan 3, 2024approval953d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Jan 3, 2024approval953d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Jan 3, 2024approval953d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Jan 3, 2024approval953d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Jan 3, 2024approval953d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Jan 4, 2024approval952d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

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

full page →fda approvals ↗

Jan 4, 2024approval952d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: NATCO. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Jan 4, 2024approval952d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: NATCO. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Jan 4, 2024approval952d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: NATCO. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Jan 4, 2024approval952d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 4, 2024approval952d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗

Jan 5, 2024approval951d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METRONIDAZOLE →fda approvals ↗

Jan 5, 2024approval951d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Jan 5, 2024approval951d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →IDACIO →fda approvals ↗

Jan 5, 2024approval951d agoTRAMADOL HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

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Week of Jan 8, 2024

Jan 9, 2024approval947d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MIKART. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Jan 10, 2024approval

Week of Jan 15, 2024

Jan 16, 2024approval940d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 16, 2024approval

Week of Jan 22, 2024

Jan 24, 2024approval932d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 24, 2024approval

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