FDA Orange Book
Generic for Megace ES
Megace ES contains megestrol acetate. 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 Megace ES is megestrol acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Megace ES products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 125MG/ML | Discontinued | None | 1 | None |
NDA 021778, 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 megestrol acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TWI PHARMACEUTICALS INC | 203139 | None (No TE code listed) | August 27, 2014 | 125MG/ML |
Questions
Is there a generic for Megace ES?
Yes. The generic name for Megace ES is megestrol acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Megace ES?
The active ingredient in Megace ES is megestrol acetate, 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.