FDA Orange Book
Generic for Accutane
Accutane contains isotretinoin. 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 Accutane is isotretinoin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Accutane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 10 | AB1, AB2 |
| capsule, oral | 20MG | Discontinued | None | 11 | AB1, AB2 |
| capsule, oral | 40MG | Discontinued | None | 11 | AB1, AB2 |
NDA 018662, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic isotretinoin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 075945 | AB1 (A-rated, therapeutically equivalent) | November 8, 2002 | 10MG, 20MG, 40MG |
| TEVA PHARMACEUTICALS USA | 076356 | AB1 (A-rated, therapeutically equivalent) | April 11, 2003 | 10MG |
| TEVA PHARMACEUTICALS USA | 076135 | AB1 (A-rated, therapeutically equivalent) | April 11, 2003 | 20MG, 40MG |
| UPSHER SMITH LABORATORIES LLC | 076485 | AB1 (A-rated, therapeutically equivalent) | January 19, 2012 | 10MG, 20MG, 40MG |
| DR REDDYS LABORATORIES LTD | 202099 | AB1 (A-rated, therapeutically equivalent) | March 25, 2013 | 10MG, 20MG, 40MG |
| AMNEAL PHARMACEUTICALS OF NY LLC | 207792 | AB1 (A-rated, therapeutically equivalent) | September 29, 2017 | 10MG, 20MG, 40MG |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 205063 | AB2 (A-rated, therapeutically equivalent) | March 31, 2021 | 10MG, 20MG, 40MG |
| UPSHER SMITH LABORATORIES LLC | 213571 | AB2 (A-rated, therapeutically equivalent) | April 12, 2021 | 40MG |
| UPSHER SMITH LABORATORIES LLC | 212333 | AB2 (A-rated, therapeutically equivalent) | September 21, 2021 | 10MG, 20MG |
| ZYDUS PHARMACEUTICALS USA INC | 211568 | AB1 (A-rated, therapeutically equivalent) | August 29, 2023 | 10MG, 20MG, 40MG |
| AUROBINDO PHARMA LTD | 218194 | AB2 (A-rated, therapeutically equivalent) | January 29, 2024 | 10MG, 20MG, 40MG |
| ZYDUS PHARMACEUTICALS USA INC | 216633 | AB2 (A-rated, therapeutically equivalent) | May 22, 2025 | 10MG, 20MG, 40MG |
| AUROBINDO PHARMA LTD | 220336 | AB1 (A-rated, therapeutically equivalent) | September 10, 2026 | 20MG, 40MG |
Questions
Is there a generic for Accutane?
Yes. The generic name for Accutane is isotretinoin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Accutane?
The active ingredient in Accutane is isotretinoin, 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.