Drug Master Files for: enalapril maleate
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enalapril maleate 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 |
11170 | I | II | 10/28/1994 | MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC | ENALAPRIL MALEATE & DILTIAZEM ER TABLETS |
11525 | A | II | 5/19/1995 | FARMHISPANIA SA | ENALAPRIL MALEATE |
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 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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