FDA Orange Book

Generic for Atralin

Atralin contains tretinoin. 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 Atralin is tretinoin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Atralin products in the Orange Book

Atralin products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, topical	0.05%	Marketed (Rx)	AB	1	AB

NDA 022070, held by DOW PHARMACEUTICAL SCIENCES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tretinoin

Approved generic versions of Atralin
Company	ANDA	TE code	Approved	Strengths
MYLAN PHARMACEUTICALS INC	207955	AB (A-rated, therapeutically equivalent)	August 13, 2015	0.05%

Atralin NDC codes

Questions

Is there a generic for Atralin?

Yes. The generic name for Atralin is tretinoin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Atralin?

The active ingredient in Atralin is tretinoin, 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.