Drug Master Files for: ESTRONE
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ESTRONE 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 |
| 11019 | A | II | 8/1/1994 | BAYER AG | ESTRONE |
| 13977 | I | II | 2/16/1999 | PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINA | DEHYDROESTRONE |
| 28304 | A | II | 5/13/2014 | QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD | ESTRONE |
| 29230 | A | II | 3/31/2015 | ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTD | ESTRONE |
| 3588 | I | II | 8/6/1979 | DIOSYNTH BV | ESTRONE MICRONIZED |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
