8-Mop, Oxsoralen

NDA 9048, held by Valeant Pharm Intl. Methoxsalen.

As of Nov 13, 2026, NDA 9048 (8-Mop, Oxsoralen), held by Valeant Pharm Intl, was first approved by FDA on Dec 3, 1954, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1954
Review: Priority
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Mar 23, 1988	Supplement 30Efficacy (new indication or use)	Approved	None posted
Dec 3, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


8-Mop10MG · capsule;oral	Methoxsalen	DiscontinuedReference drug
Oxsoralen1% · lotion;topical	Methoxsalen	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Jul 30, 2015	Supplement 48Manufacturing · Priority review	Approved	None posted
Jul 28, 2015	Supplement 47Manufacturing · Priority review	Approved	None posted
Sep 20, 2013	Supplement 46Labeling	Approved	None posted
Mar 22, 2013	Supplement 45Manufacturing · Priority review	Approved	None posted
Mar 26, 2003	Supplement 37Labeling · Standard review	Approved	Letter Label
Oct 31, 2001	Supplement 40Manufacturing · Priority review	Approved	None posted
Apr 5, 2000	Supplement 38Manufacturing · Priority review	Approved	None posted
Apr 7, 1998	Supplement 36Manufacturing · Priority review	Approved	None posted
Mar 16, 1998	Supplement 35Manufacturing · Priority review	Approved	None posted
Sep 23, 1997	Supplement 34Manufacturing · Priority review	Approved	None posted
Sep 23, 1997	Supplement 33Manufacturing · Priority review	Approved	None posted
Jan 25, 1996	Supplement 31Manufacturing · Priority review	Approved	None posted
Mar 23, 1988	Supplement 30Efficacy (new indication or use)	Approved	None posted
Apr 16, 1984	Supplement 25Labeling	Approved	None posted
Apr 21, 1983	Supplement 22Labeling	Approved	None posted
May 7, 1982	Supplement 21Labeling	Approved	None posted
May 7, 1982	Supplement 20Labeling	Approved	None posted
Apr 4, 1975	Supplement 6Labeling	Approved	None posted
Nov 13, 1974	Supplement 5	Approved	None posted
Dec 3, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 9048
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals International

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters