Is there a generic for Cisapride monohydrate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Cisapride monohydrate. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Cisapride monohydrate?

PROPULSID QUICKSOLV (NDA 020767, JANSSEN PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cisapride monohydrate are approved?

Cisapride monohydrate is approved in the following dosage forms: suspension, tablet, tablet, orally disintegrating.

FDA Orange Book · active-ingredient family

Cisapride monohydrate

Cisapride monohydrate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PROPULSID QUICKSOLV · NDA 020767

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension, tablet, tablet, orally disintegrating

Product	Applicant	Application	TE	Approved
PROPULSID QUICKSOLV	JANSSEN PHARMA	NDA 020767	—	Nov 07, 1997
PROPULSID	JANSSEN PHARMS	NDA 020398	—	Sep 15, 1995
PROPULSID×2	JANSSEN PHARMS	NDA 020210	—	Jul 29, 1993

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.

Cisapride monohydrate — frequently asked questions

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

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