FDA Orange Book
Generic for Retin-A MICRO
Retin-A MICRO 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 Retin-A MICRO is tretinoin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Retin-A MICRO products the Orange Book lists.
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Retin-A MICRO products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 0.04% | Marketed (Rx) | None | 0 | None |
| gel, topical | 0.06% | Marketed (Rx) | AB | 1 | AB |
| gel, topical | 0.08% | Marketed (Rx) | AB | 2 | AB |
| gel, topical | 0.1% | Marketed (Rx) | None | 0 | None |
NDA 020475, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tretinoin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ENCUBE ETHICALS PRIVATE LTD | 215609 | AB (A-rated, therapeutically equivalent) | April 15, 2026 | 0.06%, 0.08% |
| AMNEAL PHARMACEUTICALS LLC | 217497 | AB (A-rated, therapeutically equivalent) | May 14, 2026 | 0.08% |
Retin-A MICRO NDC codes
Questions
Is there a generic for Retin-A MICRO?
Yes. The generic name for Retin-A MICRO is tretinoin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Retin-A MICRO products the Orange Book lists.
What is the generic name for Retin-A MICRO?
The active ingredient in Retin-A MICRO 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.
More on Retin-A MICRO and Tretinoin
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- NDC 0187-5140Retin-A MICRO NDC record
- NDC 0187-5144Retin-A MICRO NDC record
- NDC 0187-5146Retin-A MICRO NDC record