Drug Master Files for: bupivacaine hydrochloride
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bupivacaine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11938 | A | II | 4/18/1996 | SIEGFRIED EVIONNAZ SA | BUPIVACAINE BASE |
| 19177 | A | II | 2/10/2006 | CAMBREX KARLSKOGA AB | BUPIVACAINE BASE |
| 20959 | A | II | 10/18/2007 | DISHMAN CARBOGEN AMCIS LTD | BUPIVACAINE HYDROCHLORIDE |
| 21196 | A | II | 12/20/2007 | EXCELLA GMBH AND CO KG | Bupivacaine Hydrochloride |
| 22228 | A | II | 11/24/2008 | MOEHS IBERICA SL | BUPIVACAINE HYDROCHLORIDE |
| 25090 | I | II | 7/27/2011 | EXCELLA GMBH | BUPIVACAINE (S) HYDROCHLORIDE |
| 26649 | I | II | 12/28/2012 | FRESENIUS KABI ONCOLOGY LTD | BUPIVACAINE HYDROCHLORIDE |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
