Drug Master Files for: prilocaine hydrochloride
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prilocaine hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14144 | A | II | 5/12/1999 | SIEGFRIED EVIONNAZ SA | PRILOCAINE BASE |
15772 | A | II | 12/18/2001 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PRILOCAINE USP |
25252 | I | II | 8/30/2011 | GUFIC BIOSCIENCES LTD | PRILOCAINE USP |
27586 | A | II | 9/24/2013 | MOEHS IBERICA SL | PRILOCAINE HYDROCHLORIDE |
32283 | A | II | 12/7/2017 | NORTEC QUIMICA SA | PRILOCAINE |
32818 | A | II | 6/29/2018 | MOEHS IBERICA SL | PRILOCAINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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