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Last Updated: May 26, 2022

Cholic acid - Generic Drug Details


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

Cholic acid is the generic ingredient in one branded drug marketed by Travere and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are forty-four drug master file entries for cholic acid. One supplier is listed for this compound.

Summary for cholic acid
Recent Clinical Trials for cholic acid

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

SponsorPhase
Vanderbilt University Medical CenterPhase 3
University of TorontoPhase 3
Brooke Army Medical CenterPhase 3

See all cholic acid clinical trials

Pharmacology for cholic acid
Drug ClassBile Acid

US Patents and Regulatory Information for cholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Travere CHOLBAM cholic acid CAPSULE;ORAL 205750-001 Mar 17, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Travere CHOLBAM cholic acid CAPSULE;ORAL 205750-002 Mar 17, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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