Calendar

Week of Dec 18, 2023

Dec 18, 2023approval989d agoPERCOCET (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: OZANTRI. Form: TABLET. Route: ORAL

Dec 18, 2023approval989d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoPERCOCET (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: OZANTRI. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoPERCOCET (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: OZANTRI. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 18, 2023approval989d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 18, 2023approval989d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 19, 2023approval988d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

full page →apalutamide →fda approvals ↗

Dec 19, 2023approval988d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 19, 2023approval988d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 19, 2023approval988d agoBUTORPHANOL TARTRATE PRESERVATIVE FREE (BUTORPHANOL TARTRATE) — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 19, 2023approval988d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

Dec 20, 2023approval987d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 20, 2023approval987d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 20, 2023approval987d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 20, 2023approval987d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

Dec 20, 2023approval987d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗

Dec 21, 2023approval986d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →eplontersen sodium →fda approvals ↗

Dec 21, 2023approval986d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 21, 2023approval986d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 22, 2023approval985d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

full page →YUFLYMA →fda approvals ↗

Dec 22, 2023approval985d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

full page →YUFLYMA →fda approvals ↗

Dec 22, 2023approval985d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

full page →YUFLYMA →fda approvals ↗

Week of Dec 25, 2023

Dec 26, 2023approval981d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →infliximab biosimilar →fda approvals ↗

Dec 26, 2023approval

Week of Jan 1, 2024

Jan 2, 2024approval974d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 2, 2024approval

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Week of Dec 25, 2023

Week of Jan 1, 2024