Rifampin
ANDA 65028, held by Hikma. Rifampin.
- First approved: Mar 14, 2001
- Supplements approved: 4
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 5 submissions below| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2001 | Original application | Approved |
Products
2 strengths and formsAll 5 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2015 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jun 27, 2011 | Supplement 12Labeling | Approved | None posted |
| Jun 3, 2004 | Supplement 4Labeling | Approved | None posted |
| Aug 20, 2002 | Supplement 1Labeling | Approved | None posted |
| Mar 14, 2001 | Original application | Approved |
Identifiers
- Application
- ANDA 65028
- Drugs@FDA
- Overview at FDA
- Company
- Hikma
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