FDA Orange Book

Generic for Synalar

Synalar contains fluocinolone acetonide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Synalar is fluocinolone acetonide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.

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Synalar products in the Orange Book

Synalar products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
cream, topical	0.01%	Marketed (Rx)	AT	2	AT
cream, topical	0.025%	Marketed (Rx)	AT	2	AT
cream, topical	0.025%	Marketed (Rx)	AT	2	AT
ointment, topical	0.025%	Marketed (Rx)	AT	2	AT
solution, topical	0.01%	Marketed (Rx)	AT	5	AT

NDA 012787, 013960, 015296, held by EUROFARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic fluocinolone acetonide

Approved generic versions of Synalar
Company	ANDA	TE code	Approved	Strengths
FOUGERA PHARMACEUTICALS INC	088170	AT (A-rated, therapeutically equivalent)	December 16, 1982	0.01%
FOUGERA PHARMACEUTICALS INC	088169	AT (A-rated, therapeutically equivalent)	December 16, 1982	0.025%, 0.025%
FOUGERA PHARMACEUTICALS INC	088168	AT (A-rated, therapeutically equivalent)	December 16, 1982	0.025%
FOUGERA PHARMACEUTICALS INC	088167	AT (A-rated, therapeutically equivalent)	December 16, 1982	0.01%
SUN PHARMA CANADA INC	089124	AT (A-rated, therapeutically equivalent)	September 11, 1985	0.01%
COSETTE PHARMACEUTICALS NC LABORATORIES LLC	089526	AT (A-rated, therapeutically equivalent)	July 26, 1988	0.01%
COSETTE PHARMACEUTICALS NC LABORATORIES LLC	089524	AT (A-rated, therapeutically equivalent)	July 26, 1988	0.025%
LUPIN INC	206422	AT (A-rated, therapeutically equivalent)	September 2, 2015	0.01%
CHARTWELL RX SCIENCES LLC	209596	AT (A-rated, therapeutically equivalent)	December 26, 2017	0.01%
COSETTE PHARMACEUTICALS NC LABORATORIES LLC	210747	AT (A-rated, therapeutically equivalent)	November 5, 2018	0.025%, 0.025%
ENCUBE ETHICALS PVT LTD	209913	AT (A-rated, therapeutically equivalent)	February 13, 2019	0.01%

Synalar NDC codes

Questions

Is there a generic for Synalar?

Yes. The generic name for Synalar is fluocinolone acetonide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.

What is the generic name for Synalar?

The active ingredient in Synalar is fluocinolone acetonide, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.