FDA Orange Book
Generic for Fortesta
Fortesta contains testosterone. 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 Fortesta is testosterone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Fortesta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, metered, transdermal | 10MG/0.5GM ACTUATION | Discontinued | None | 1 | None |
NDA 021463, held by ENDO OPERATIONS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic testosterone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 204571 | None (No TE code listed) | August 5, 2015 | 10MG/0.5GM ACTUATION |
Questions
Is there a generic for Fortesta?
Yes. The generic name for Fortesta is testosterone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Fortesta?
The active ingredient in Fortesta is testosterone, 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.