Drug Master Files for: articaine
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articaine Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11877 | A | II | 3/4/1996 | SCI PHARMTECH INC | ARTICAINE HYDROCHLORIDE DRUG SUBSTANCE |
15919 | A | II | 3/28/2002 | SIEGFRIED EVIONNAZ SA | ARTICAINE HYDROCHLORIDE |
16469 | A | II | 3/18/2003 | ORGAPHARM SAS | ARTICAINE HYDROCHLORIDE DRUG SUBSTANCE |
17935 | A | II | 12/20/2004 | PCAS | ARTICAINE HCL |
20118 | I | II | 12/19/2006 | SANOFI AVENTIS DEUTSCHLAND GMBH | ARTICAINE HYDROCHLORIDE |
20287 | A | II | 2/20/2007 | SANOFI INDIA LTD | ARTICAINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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