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Last Updated: August 12, 2020

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HYDROCORTISONE ACETATE - Generic Drug Details

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What are the generic 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, Imperium, 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, Ferndale Labs, 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
Feinstein Institute for Medical ResearchPhase 2
University of Texas Southwestern Medical CenterPhase 2
National Institutes of Health Clinical Center (CC)Phase 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
Ingram Pharm DRICORT hydrocortisone acetate LOTION;TOPICAL 086207-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride CREAM;TOPICAL 085368-001 Approved Prior to Jan 1, 1982 RX No No   Start Trial   Start Trial   Start Trial
Watson Labs HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 083759-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm HYDROCORTISONE ACETATE hydrocortisone acetate CREAM;TOPICAL 086050-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085980-001 Approved Prior to Jan 1, 1982 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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