Drug Master Files for: MEDROXYPROGESTERONE ACETATE
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MEDROXYPROGESTERONE ACETATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12695 | A | II | 10/15/1997 | FARMABIOS SPA | MEDROXYPROGESTERONE ACETATE |
| 12703 | A | II | 10/20/1997 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MEDROXYPROGESTERONE ACETATE |
| 15223 | I | II | 1/4/2001 | STERLING SRL | MEDROXYPROGESTERONE ACETATE |
| 19433 | A | II | 5/10/2006 | ZHEJIANG XIANJU PHARMACEUTICAL CO LTD | MEDROXYPROGESTERONE ACETATE USP, NON-STERILE BULK DRUG SUBSTANCE |
| 1988 | I | II | 8/28/1972 | SEARLE | NORTHINDQONE, MESTRANOL, MEDROXYPROGESTERONE |
| 21563 | I | II | 1/15/2008 | YANCHENG XINYI PHARM AND CHEM CO LTD | MEDROXYPROGESTERONE ACETATE (NON-STERILE BULK FORM) |
| 26389 | A | II | 9/4/2012 | FARMABIOS SPA | STERILIZED MEDROXYPROGESTERONE ACETATE USP ( 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
