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Last Updated: August 8, 2020

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Hydrocortisone acetate - Generic Drug Details

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What are the generic drug sources for hydrocortisone acetate and what is the scope of freedom to operate?

Hydrocortisone acetate is the generic ingredient in nineteen branded drugs marketed by Mylan Speciality Lp, Able, Cenci, Ferndale Labs, Parke Davis, Purepac Pharm, Sebela Ireland Ltd, Pharmacia And Upjohn, Pfizer, Akorn, Bel Mar, Watson Labs, Merck, Ingram Pharm, Fera Pharms, Colgate, X Gen Pharms, Monarch Pharms, Genus, Fougera Pharms, and Taro, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-seven drug master file entries for hydrocortisone acetate. One supplier is listed for this compound.

Recent Clinical Trials for hydrocortisone acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Hospital Los AngelesPhase 2
University of MichiganPhase 2
Feinstein Institute for Medical ResearchPhase 2

See all hydrocortisone acetate clinical trials

Pharmacology for hydrocortisone acetate

US Patents and Regulatory Information for hydrocortisone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 009637-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bel Mar HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 083739-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp PROCTOFOAM HC hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086195-001 Approved Prior to Jan 1, 1982 BX RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Moodys
Johnson and Johnson
Medtronic
Colorcon

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