FDA Orange Book
Generic for Desoxyn
Desoxyn contains methamphetamine. 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 Desoxyn is methamphetamine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 4 Desoxyn products the Orange Book lists.
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Desoxyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 15MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 5MG | Discontinued | None | 0 | None |
| tablet, oral | 5MG | Marketed (Rx) | AA | 2 | AA |
NDA 005378, held by AJENAT PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methamphetamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 091189 | AA (A-rated, therapeutically equivalent) | April 21, 2010 | 5MG |
| HIKMA PHARMACEUTICALS USA INC | 203846 | AA (A-rated, therapeutically equivalent) | November 17, 2015 | 5MG |
Questions
Is there a generic for Desoxyn?
Yes. The generic name for Desoxyn is methamphetamine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 4 Desoxyn products the Orange Book lists.
What is the generic name for Desoxyn?
The active ingredient in Desoxyn is methamphetamine, 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.