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: 2 brands, 2 generics; first approved Sep 23, 1991; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

DERMATOP E EMOLLIENTRLD
VALEANT BERMUDANDA 0202791993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% CREAM TOPICAL Discontinued -
DERMATOPRLD
VALEANT PHARMS NORTHNDA 0195681991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% OINTMENT TOPICAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	OINTMENT	TOPICAL	Discontinued	-

Generic (ANDA) products (2)

Abbreviated applications

PREDNICARBATERS
FOUGERA PHARMSANDA 0772362007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% OINTMENT TOPICAL Rx -
PREDNICARBATE
FOUGERA PHARMSANDA 0772872006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% CREAM TOPICAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	OINTMENT	TOPICAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	-

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

First approval

Sep 23, 1991

35 yr 7 mo ago

Most recent approval

Mar 09, 2007

19 yr 11 mo ago

Approvals span 1991–2007 across 4 FDA applications.

Brand (NDA) 250%

Generic (ANDA) 250%

Prednicarbate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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Key facts