Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Oxsoralen-Ultra (methoxsalen), USP, Capsules, 10 mg, ICN NDA 19-600/S-006 & S-009 UVADEX (methosalen) Sterile Solution, 20 mcg/mL, Therakos, NDA 20-969 2/25/99 3/2/99 3/2/99 6/14/99 UVADEX Indication:This new drug application provides for the use of UVADEX® (methoxsalen) Sterile Solution with the UVAR® Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. METHOXSALEN Capsule; 10MG 8-MOP ICN 019600 METHOXSALEN Capsule; 10MG OXSORALEN-ULTRA ICN 020969 METHOXSALEN Injection 0.02MG/ML UVADEX THERAKOS 009048 METHOXSALEN Lotion; Topical 1% OXSORALEN ICN ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com