Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 submissions below| Date | Submission | Status | Documents |
|---|
| Sep 21, 2010 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Rifampin600MG/VIAL · injectable;injection | Rifampin | Rx |
All 3 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Nov 25, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 18, 2012 | Supplement 1Labeling | Approved | None posted |
| Sep 21, 2010 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 65502
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
