FDA Orange Book

Generic for Vesanoid

Vesanoid 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 Vesanoid is tretinoin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Vesanoid products in the Orange Book

Vesanoid products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral10MGDiscontinuedNone2AB

NDA 020438, held by CHEPLAPHARM ARZNEIMITTEL GMBH. 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 Vesanoid
CompanyANDATE codeApprovedStrengths
PH HEALTH LTD201687AB (A-rated, therapeutically equivalent)October 24, 201210MG
GLENMARK PHARMACEUTICALS LTD208279AB (A-rated, therapeutically equivalent)December 23, 201610MG

Questions

Is there a generic for Vesanoid?

Yes. The generic name for Vesanoid is tretinoin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Vesanoid?

The active ingredient in Vesanoid 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.

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