Rifampin
ANDA 90034, held by Lupin Pharms. Rifampin.
- First approved: Aug 21, 2013
- Supplements approved: 11
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions below| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2013 | Original application | Approved | None posted |
Products
2 strengths and formsAll 12 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 2023 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jun 30, 2023 | Supplement 21Labeling · Standard review | Approved | None posted |
| Aug 30, 2022 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 30, 2022 | Supplement 18Labeling · Standard review | Approved | None posted |
| Sep 14, 2021 | Supplement 15Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 31, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 31, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 31, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 31, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 31, 2020 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 21, 2013 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 90034
- Drugs@FDA
- Overview at FDA
- Company
- Lupin Pharmaceuticals
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