Drug Master Files for: ENALAPRILAT
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ENALAPRILAT Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10200 | I | III | 4/19/1993 | 3M PHARMACEUTICALS | METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN URINe |
| 11622 | I | V | 7/20/1995 | PHARMACO LIFE SCIENCE RESEARCH | METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN URINE |
| 11623 | I | V | 7/20/1995 | PHARMACO LIFE SCIENCE RESEARCH | METHOD MS23 REVISION 1 GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN PLASMA |
| 12347 | I | III | 1/16/1997 | 3M DRUG DELIVERY SYSTEMS | METHOD MS23 REVISION 1 GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN PLASMA |
| 12711 | A | II | 10/21/1997 | ESTEVE QUIMICA SA | ENALAPRILAT |
| 13835 | I | II | 11/9/1998 | DR REDDYS LABORATORIES LTD | ENALAPRILAT, 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
