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Last Updated: August 8, 2020

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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, Hi Tech Pharma, 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. Twelve suppliers are listed for this compound.

Summary for acetic acid, glacial
Recent Clinical Trials for acetic acid, glacial

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

SponsorPhase
National Council of Science and Technology, MexicoPhase 4
National Institute of PerinatologyPhase 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
Bausch And Lomb ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE acetic acid, glacial; aluminum acetate SOLUTION/DROPS;OTIC 040063-001 Feb 25, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Bayer Pharms TRIDESILON acetic acid, glacial; desonide SOLUTION/DROPS;OTIC 017914-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare ACETIC ACID 0.25% IN PLASTIC CONTAINER acetic acid, glacial SOLUTION;IRRIGATION, URETHRAL 018523-001 Feb 19, 1982 AT RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 040166-001 Jul 26, 1996 AT RX No Yes   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic ACETASOL acetic acid, glacial SOLUTION/DROPS;OTIC 087146-001 Approved Prior to Jan 1, 1982 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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