Rifampin
Sold as Rifadin, Rimactane. Every FDA application for this active ingredient: 3 branded and 12 generic.
- First approved: May 21, 1971
- Applications: 15
- New uses approved: 2
- Complete response letters: 0
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| May 21, 1971 | RifadinNDA 50420 | Sanofi Aventis US | 87 | Discontinued |
| May 21, 1971 | RimactaneNDA 50429 | Tp Anda Holdings | 83 | Marketed |
| May 25, 1989 | RifadinNDA 50627 · New dosage form | Sanofi Aventis US | 27 | Marketed |
| May 28, 1997 | RifampinANDA 64150 | Epic Pharma LLC | 19 | Marketed |
| Oct 29, 1999 | RifampinANDA 64217 | Hikma | 5 | Marketed |
| Mar 14, 2001 | RifampinANDA 65028 | Hikma | 4 | Discontinued |
| Mar 28, 2008 | RifampinANDA 65390 | Chartwell Molecular | 12 | Marketed |
| May 22, 2008 | RifampinANDA 65421 | Mylan Labs Ltd | 10 | Marketed |
| Sep 21, 2010 | RifampinANDA 65502 | Epic Pharma LLC | 2 | Marketed |
| Aug 21, 2013 | RifampinANDA 90034 | Lupin Pharms | 11 | Marketed |
| Aug 18, 2014 | RifampinANDA 204101 | Avet Lifesciences | 7 | Discontinued |
| Aug 21, 2014 | RifampinANDA 91181 | Fresenius Kabi USA | 9 | Marketed |
| Jan 19, 2016 | RifampinANDA 206736 | Watson Pharms Teva | 3 | Discontinued |
| Mar 3, 2016 | RifampinANDA 205039 | Hikma Pharms | 4 | Marketed |
| Jun 29, 2026 | RifampinANDA 219918 | Novitium Pharma | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA