Drug Master Files for: Avent
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Avent Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10944 | A | II | 6/17/1994 | AVENTIS PHARMA MANUFACTURING PTE LTD | NEDOCROMIL SODIUM |
11030 | I | II | 7/27/1994 | AVENTIS PHARMA SA | HEMATOROPHYRINE DIHYDROCHLORIDE,PACKAGED AND TESTED IN VERTOLAYE,FRANCE |
11413 | I | II | 3/28/1995 | SANOFI AVENTIS US INC | MDL 101,731 |
11785 | A | II | 12/18/1995 | SANOFI AVENTIS DEUTSCHLAND GMBH | FUROSEMIDE (BULK) |
12136 | I | II | 9/12/1996 | AVENTIS PHARMA DEUTSCHLAND GMBH | GLYBURIDE [MILLED (GROUND)] |
12165 | I | II | 10/7/1996 | AVENTIS PHARMA DEUTSCHLAND GMBH | GLYBURIDE (MICRONIZED) BULK DRUG SUBSTANCE |
12272 | I | II | 12/6/1996 | AVENTIS PHARMA DEUTSCHLAND GMBH | BULK PROTIRELIN (THYROID RELEASING HORMONE; TRH) DRUG SUBSTANCE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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