NDA 19600, held by Bausch. Methoxsalen.
As of Nov 14, 2026, NDA 19600 (Oxsoralen-Ultra), held by Bausch, was first approved by FDA on Oct 30, 1986, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 1986 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxsoralen-Ultra10MG · capsule;oral | Methoxsalen | RxReference drug |
| Oct 20, 2015 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| May 29, 2015 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 26, 2003 | Supplement 6Labeling · Standard review | Approved | |
| Mar 26, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Nov 23, 2001 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 20, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 7, 1999 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1997 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1990 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1986 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
