Is there a generic for Dinoprostone?

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

What is the reference-listed drug for Dinoprostone?

CERVIDIL (NDA 020411, FERRING PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dinoprostone are approved?

Dinoprostone is approved in the following dosage forms: gel, insert, extended release, suppository.

FDA Orange Book · active-ingredient family

Dinoprostone

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

Reference-listed drug:CERVIDIL · NDA 020411

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel, insert, extended release, suppository

Product	Applicant	Application	TE	Approved
CERVIDILRLD	FERRING PHARMS INC	NDA 020411	—	Mar 30, 1995
PREPIDILRLD	PFIZER	NDA 019617	—	Dec 09, 1992
PROSTIN E2RLD	PFIZER	NDA 017810	—	Approved Prior to Jan 1, 1982

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.

Dinoprostone — frequently asked questions

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

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