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Last Updated: August 6, 2020

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ACETIC ACID, GLACIAL; HYDROCORTISONE - Generic Drug Details

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What are the generic sources for acetic acid, glacial; hydrocortisone and what is the scope of patent protection?

Acetic acid, glacial; hydrocortisone is the generic ingredient in six branded drugs marketed by Actavis Mid Atlantic, Kv Pharm, Bausch And Lomb, Cosette, Taro Pharm Inds Ltd, Wockhardt, Warner Chilcott, Hi Tech Pharma, and Bayer Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for acetic acid, glacial; hydrocortisone. Two suppliers are listed for this compound.

Summary for ACETIC ACID, GLACIAL; HYDROCORTISONE
Pharmacology for ACETIC ACID, GLACIAL; HYDROCORTISONE

US Patents and Regulatory Information for ACETIC ACID, GLACIAL; HYDROCORTISONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kv Pharm ACETIC ACID W/ HYDROCORTISONE acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 085492-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hi Tech Pharma VOSOL HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 012770-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch And Lomb HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040097-001 Oct 31, 1994 DISCN 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:

Colorcon
Moodys
Merck
McKinsey
Medtronic
Harvard Business School

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