Drug Master Files for: ESTRADIOL
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ESTRADIOL Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10115 | I | II | 3/3/1993 | PHARMACO LIFE SCIENCE RESEARCH | METHOD VALIDATION REPORT, METHOD 29, GC/MS ANALYSIS OF UNCONJUGATED ESTRONE AND 17B-ESTRADIOL IN HUMAN PLASMA |
10536 | I | II | 10/18/1993 | PHARMACIA AND UPJOHN SUB PFIZER INC | ESTRADIOL |
10542 | I | II | 10/25/1993 | CYGNUS INC | ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM |
10591 | I | II | 11/24/1993 | CYGNUS INC | ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM |
10651 | I | II | 12/9/1993 | CYGNUS INC | ESTRADIOL TRANSDERMAL DELIVERY SYSTEM (E2 III TDS) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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