Is there a generic for Cholic acid?

The FDA Orange Book does not currently list an approved generic (ANDA) for Cholic acid. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Cholic acid?

CHOLBAM (NDA 205750, MIRUM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cholic acid are approved?

Cholic acid is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Cholic acid

Cholic acid is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CHOLBAM · NDA 205750

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
CHOLBAMRLD×2	MIRUM	NDA 205750	—	Mar 17, 2015

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Cholic acid — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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