Approvals and New Uses
The original application and every efficacy supplement, newest first; all 5 submissions below| Date | Submission | Status | Documents |
|---|
| Mar 3, 2016 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Rifampin600MG/VIAL · injectable;injection | Rifampin | Rx |
All 5 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Jul 1, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 1, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 1, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 1, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 3, 2016 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 205039
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
