FDA Orange Book
Generic for Oxsoralen-ultra
Oxsoralen-ultra contains methoxsalen. 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 Oxsoralen-ultra is methoxsalen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Oxsoralen-ultra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Marketed (Rx) | AB | 1 | AB |
NDA 019600, held by BAUSCH HEALTH AMERICAS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methoxsalen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ONESOURCE SOFTGELS PTE LTD | 202687 | AB (A-rated, therapeutically equivalent) | June 5, 2014 | 10MG |
Questions
Is there a generic for Oxsoralen-ultra?
Yes. The generic name for Oxsoralen-ultra is methoxsalen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Oxsoralen-ultra?
The active ingredient in Oxsoralen-ultra is methoxsalen, 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.