Drug Master Files for: Sanofi Synthelabo
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Sanofi Synthelabo Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11089 | I | II | 9/16/1994 | SANOFI SYNTHELABO INC | ISOETHARINE MESYLATE AND ISOETHARINE HYDROCHLORIDE |
11217 | I | II | 11/30/1994 | SANOFI SYNTHELABO INC | BEFLOXATONE |
11976 | I | II | 5/14/1996 | SANOFI SYNTHELABO INC | ALFUZOSIN HYDROCHLORIDE DRUG SUBSTANCE |
12460 | I | II | 4/8/1997 | SANOFI SYNTHELABO INC | CLOPIDOGREL BISULFATE |
12916 | I | II | 3/26/1998 | SANOFI SYNTHELABO INC | R-ZACOPRIDE |
12991 | I | II | 5/18/1998 | SANOFI SYNTHELABO INC | SUCCIMER (MESO-2,3-DIMERCAPTOSUCCINIC ACID) |
3926 | I | II | 7/31/1980 | SANOFI SYNTHELABO INC | CLOROQUINE PHOSPHATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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