Drug Master Files for: fosinopril sodium
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fosinopril sodium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15326 | A | II | 2/28/2001 | AMINO CHEMICALS LTD | FOSINOPRIL SODIUM |
| 15934 | I | II | 4/11/2002 | QUIMICA SINTETICA SA | FOSINOPRIL SODIUM |
| 16008 | A | II | 6/11/2002 | HETERO DRUGS LTD | FOSINOPRIL SODIUM |
| 16321 | I | II | 12/17/2002 | SUN PHARMACEUTICAL INDUSTRIES LTD | FOSINOPRIL SODIUM USP (NON-STERILE BULK) |
| 17805 | A | II | 10/27/2004 | ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD | FOSINOPRIL SODIUM USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
