Drug Master Files for: Sanofi
✉ Email this page to a colleague
Sanofi Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10310 | A | II | 6/30/1993 | SANOFI CHIMIE | IRBESARTAN DRUG SUBSTANCE |
11000 | I | II | 7/25/1994 | SANOFI RECHERCHE | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOULOUSE, FRANCE. |
11052 | I | II | 8/26/1994 | SANOFI WINTHROP INC | MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT COLLEGEVIEW, PA |
11089 | I | II | 9/16/1994 | SANOFI SYNTHELABO INC | ISOETHARINE MESYLATE AND ISOETHARINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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