Pindolol
ANDA 74063, held by Sun Pharm Industries. Pindolol.
- First approved: Jan 27, 1994
- Supplements approved: 9
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 10 submissions below| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 1994 | Original application | Approved | None posted |
Products
2 strengths and formsAll 10 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2015 | Supplement 17Manufacturing | Approved | None posted |
| Dec 2, 2002 | Supplement 8Manufacturing | Approved | None posted |
| Feb 15, 2001 | Supplement 7Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 5Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Dec 5, 1997 | Supplement 4Manufacturing | Approved | None posted |
| Feb 24, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Apr 17, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Jun 22, 1995 | Supplement 1Manufacturing | Approved | None posted |
| Jan 27, 1994 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 74063
- Drugs@FDA
- Overview at FDA
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