Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions below| Date | Submission | Status | Documents |
|---|
| Mar 3, 1971 | Original application | Approved | None posted |
Products
6 strengths and formsAll 12 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| May 1, 2024 | Supplement 52Labeling · Standard review | Approved | None posted |
| Apr 16, 2020 | Supplement 47Labeling · Standard review | Approved | None posted |
| Feb 21, 2018 | Supplement 43Labeling · Standard review | Approved | None posted |
| Sep 1, 2015 | Supplement 37Labeling | Approved | None posted |
| Jul 17, 2015 | Supplement 32Labeling | Approved | None posted |
| Jan 25, 2011 | Supplement 34Labeling | Approved | None posted |
| Oct 31, 2007 | Supplement 29Manufacturing | Approved | None posted |
| Oct 4, 2004 | Supplement 24Labeling | Approved | None posted |
| Oct 4, 2004 | Supplement 25Labeling | Approved | None posted |
| Dec 4, 2001 | Supplement 20Manufacturing | Approved | None posted |
| Jan 23, 1992 | Supplement 19Labeling | Approved | None posted |
| Mar 3, 1971 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 61395
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
