Approvals and New Uses
The original application and every efficacy supplement, newest first; all 8 submissions below| Date | Submission | Status | Documents |
|---|
| Aug 18, 2014 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Rifampin600MG/VIAL · injectable;injection | Rifampin | Discontinued |
All 8 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Apr 2, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 2, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 26, 2021 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 25, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 11, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 11, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 11, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 18, 2014 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 204101
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