FDA Orange Book
Generic for Oreton Methyl
Oreton Methyl contains methyltestosterone. 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 Oreton Methyl is methyltestosterone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: BP. Generics match 1 of the 2 Oreton Methyl products the Orange Book lists.
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Oreton Methyl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 1 | BP |
| tablet, oral | 25MG | Discontinued | None | 0 | None |
NDA 003158, held by SCHERING CORP SUB SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methyltestosterone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 080767 | BP (B-rated, not considered equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
Questions
Is there a generic for Oreton Methyl?
Yes. The generic name for Oreton Methyl is methyltestosterone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: BP. Generics match 1 of the 2 Oreton Methyl products the Orange Book lists.
What is the generic name for Oreton Methyl?
The active ingredient in Oreton Methyl is methyltestosterone, 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.