FDA Orange Book · active-ingredient family
Methoxsalen
Methoxsalen: 3 brands, 3 generics; first approved Jun 08, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
3
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- THERAKOS DEVELOPMENTNDA 0209691999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/ML INJECTABLE INJECTION Rx — - BAUSCHNDA 0196001986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - 8-MOPRLDVALEANT PHARM INTLNDA 009048—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — 1% LOTION TOPICAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- METHOXSALENACTAVIS INCANDA 2026032015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - METHOXSALENONESOURCEANDA 2026872014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - METHOXSALENANI PHARMSANDA 0877811982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr ago
Most recent approval
11 yr 6 mo ago
Approvals span 1982–2015 across 6 FDA applications.
Brand (NDA) 350%
Generic (ANDA) 350%
Methoxsalen: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
