FDA Orange Book · active-ingredient family
Methoxsalen
Methoxsalen is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:UVADEX · NDA 020969
3
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable, lotion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| UVADEXRLD | THERAKOS DEVELOPMENT | NDA 020969 | — | Feb 25, 1999 | |
| OXSORALEN-ULTRARLD | BAUSCH | NDA 019600 | AB | Oct 30, 1986 | |
| 8-MOPRLD×2 | VALEANT PHARM INTL | NDA 009048 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHOXSALEN | ACTAVIS INC | ANDA 202603 | — | Jun 09, 2015 | |
| METHOXSALEN | ONESOURCE SPECIALTY | ANDA 202687 | AB | Jun 05, 2014 | |
| METHOXSALEN | ANI PHARMS | ANDA 087781 | — | Jun 08, 1982 |
Listed patents
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.
Methoxsalen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
