Is there a generic for Prednicarbate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Prednicarbate, referencing the brand DERMATOP E EMOLLIENT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Prednicarbate?

DERMATOP E EMOLLIENT (NDA 020279, VALEANT BERMUDA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Prednicarbate are approved?

Prednicarbate is approved in the following dosage forms: cream, ointment.

FDA Orange Book · active-ingredient family

Prednicarbate

Prednicarbate is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DERMATOP E EMOLLIENT · NDA 020279

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, ointment

Product	Applicant	Application	TE	Approved
DERMATOP E EMOLLIENTRLD	VALEANT BERMUDA	NDA 020279	—	Oct 29, 1993
DERMATOPRLD	VALEANT PHARMS NORTH	NDA 019568	—	Sep 23, 1991

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
PREDNICARBATE	FOUGERA PHARMS	ANDA 077236	—	Mar 09, 2007
PREDNICARBATE	FOUGERA PHARMS	ANDA 077287	—	Sep 19, 2006

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.

Prednicarbate — frequently asked questions

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

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