FDA Orange Book
Generic for Renova
Renova 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 Renova is tretinoin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1. Generics match 1 of the 2 Renova products the Orange Book lists.
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Renova products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.02% | Marketed (Rx) | None | 0 | None |
| cream, topical | 0.05% | Discontinued | None | 4 | AB1 |
NDA 021108, 019963, held by VALEANT PHARMACEUTICALS NORTH AMERICA 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 |
|---|---|---|---|---|
| PADAGIS US LLC | 075265 | AB1 (A-rated, therapeutically equivalent) | December 24, 1998 | 0.05% |
| SUN PHARMA CANADA INC | 211644 | AB1 (A-rated, therapeutically equivalent) | January 25, 2019 | 0.05% |
| ENCUBE ETHICALS PRIVATE LTD | 217832 | AB1 (A-rated, therapeutically equivalent) | March 25, 2026 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 214590 | AB1 (A-rated, therapeutically equivalent) | June 11, 2026 | 0.05% |
Renova NDC codes
Questions
Is there a generic for Renova?
Yes. The generic name for Renova is tretinoin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1. Generics match 1 of the 2 Renova products the Orange Book lists.
What is the generic name for Renova?
The active ingredient in Renova 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 Renova and Tretinoin
- What is Tretinoin used for?FDA label uses
- Is Tretinoin a controlled substance?Federal schedule
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