FDA Orange Book
Generic for Avita
Avita 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 Avita is tretinoin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Avita products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.025% | Marketed (Rx) | AB | 5 | AB |
| gel, topical | 0.025% | Discontinued | None | 3 | AB |
NDA 020404, 020400, held by MYLAN PHARMACEUTICALS INC. 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 | 075264 | AB (A-rated, therapeutically equivalent) | December 24, 1998 | 0.025% |
| PADAGIS US LLC | 075529 | AB (A-rated, therapeutically equivalent) | February 22, 2000 | 0.025% |
| SUN PHARMA CANADA INC | 215713 | AB (A-rated, therapeutically equivalent) | January 5, 2023 | 0.025% |
| AUROBINDO PHARMA LTD | 218245 | AB (A-rated, therapeutically equivalent) | February 27, 2025 | 0.025% |
| ENCUBE ETHICALS PRIVATE LTD | 217587 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 0.025% |
| ENCUBE ETHICALS PRIVATE LTD | 217831 | AB (A-rated, therapeutically equivalent) | July 10, 2025 | 0.025% |
| ALEMBIC PHARMACEUTICALS LTD | 218399 | AB (A-rated, therapeutically equivalent) | August 14, 2025 | 0.025% |
| ZYDUS LIFESCIENCES LTD | 218560 | AB (A-rated, therapeutically equivalent) | September 15, 2026 | 0.025% |
Avita NDC codes
Questions
Is there a generic for Avita?
Yes. The generic name for Avita is tretinoin. 6 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 Avita?
The active ingredient in Avita 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.