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Last Updated: August 3, 2021

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Acetic acid, glacial - Generic Drug Details

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What are the generic drug sources for acetic acid, glacial and what is the scope of freedom to operate?

Acetic acid, glacial is the generic ingredient in fifteen branded drugs marketed by Actavis Mid Atlantic, Kv Pharm, Rising, Saptalis Pharms, Taro, Wockhardt Bio Ag, Warner Chilcott, Akorn, B Braun, Baxter Hlthcare, Icu Medical Inc, Bausch And Lomb, Pharmafair, Bayer Pharms, Cosette, Taro Pharm Inds Ltd, and Wockhardt, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for acetic acid, glacial

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

SponsorPhase
National Institute of PerinatologyPhase 4
National Council of Science and Technology, MexicoPhase 4

See all acetic acid, glacial clinical trials

US Patents and Regulatory Information for acetic acid, glacial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott ORLEX HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 086844-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bausch And Lomb HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040097-001 Oct 31, 1994 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Kv Pharm ACETIC ACID W/ HYDROCORTISONE acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 085492-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
B Braun ACETIC ACID 0.25% IN PLASTIC CONTAINER acetic acid, glacial SOLUTION;IRRIGATION, URETHRAL 018161-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Cosette HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040609-001 Feb 6, 2006 AT RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Mid Atlantic ACETASOL HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 087143-001 Jan 13, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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:

Harvard Business School
Moodys
McKesson
Merck
Colorcon
Baxter

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