Rifampin
ANDA 64150, held by Epic Pharma LLC. Rifampin.
- First approved: May 28, 1997
- Supplements approved: 19
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 20 submissions below| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 1997 | Original application | Approved |
Products
2 strengths and formsAll 20 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 2023 | Supplement 37Labeling · Standard review | Approved | None posted |
| Jan 14, 2022 | Supplement 36Labeling · Standard review | Approved | None posted |
| Sep 13, 2021 | Supplement 35Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 33Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 32Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 31Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 30Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 27Labeling · Standard review | Approved | None posted |
| Jul 19, 2013 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jun 13, 2011 | Supplement 15Labeling | Approved | None posted |
| Sep 6, 2005 | Supplement 11Labeling | Approved | None posted |
| Jun 28, 2002 | Supplement 7Manufacturing | Approved | None posted |
| Aug 9, 2000 | Supplement 6Labeling | Approved | None posted |
| Feb 2, 2000 | Supplement 5Manufacturing | Approved | None posted |
| Mar 3, 1999 | Supplement 4Manufacturing | Approved | None posted |
| May 19, 1998 | Supplement 3Manufacturing | Approved | None posted |
| Jan 2, 1998 | Supplement 2Labeling | Approved | None posted |
| Jan 2, 1998 | Supplement 1Manufacturing | Approved | None posted |
| May 28, 1997 | Original application | Approved |
Identifiers
- Application
- ANDA 64150
- Drugs@FDA
- Overview at FDA
- Company
- Epic Pharma
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