Drug Master Files for: alfuzosin hydrochloride
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alfuzosin hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11976 | I | II | 5/14/1996 | SANOFI SYNTHELABO INC | ALFUZOSIN HYDROCHLORIDE DRUG SUBSTANCE |
| 12546 | I | II | 6/3/1997 | FINORGA | ALFUZOSIN HYDROCHLORIDE |
| 17624 | A | II | 8/24/2004 | EXCELLA GMBH AND CO KG | ALFUZOSIN HYDROCHLORIDE |
| 19180 | I | II | 8/7/2006 | CIPLA LTD | ALFUZOSIN HYDROCHLORIDE |
| 19476 | A | II | 5/26/2006 | FARMAK AS | ALFUZOSIN HYDROCHLORIDE |
| 19675 | A | II | 8/10/2006 | GLENMARK PHARMACEUTICALS LTD | ALFUZOSIN HYDROCHLORIDE USP |
| 19786 | I | II | 12/1/2006 | STANDARD CHEM AND PHARM CO LTD | ALFUZOSIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
