Drug Master Files for: OMEPRAZOLE MAGNESIUM
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OMEPRAZOLE MAGNESIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11017 | I | II | 8/2/1994 | ESTEVE QUIMICA SA | OMEPRAZOLE |
| 11551 | A | II | 6/9/1995 | UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) | OMEPRAZOLE |
| 11794 | A | II | 12/21/1995 | ESTEVE QUIMICA SA | OMEPRAZOLE |
| 12605 | A | II | 7/23/1997 | QUIMICA SINTETICA SA | OMEPRAZOLE |
| 12694 | A | II | 10/9/1997 | ASTRAZENECA AB | PRILOSEC MUPS TABLETS (OMEPRAZOLE MAGNESIUM) |
| 12726 | A | II | 10/31/1997 | ASTRAZENECA AB | OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE |
| 12827 | A | II | 1/21/1998 | CIPLA LTD | OMEPRAZOLE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
