Drug Master Files for: progesterone
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progesterone Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10107 | I | II | 2/26/1993 | WATSON LABORATORIES INC | PROGESTERONE VAGINAL SUPPOSITORY 100 MG. AND 200 MG. |
12695 | A | II | 10/15/1997 | FARMABIOS SPA | MEDROXYPROGESTERONE ACETATE |
12703 | A | II | 10/20/1997 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MEDROXYPROGESTERONE ACETATE |
1418 | A | II | 9/4/1969 | PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC | PROGESTERONE MICRONIZED AND CRYSTALS |
15223 | I | II | 1/4/2001 | STERLING SRL | MEDROXYPROGESTERONE ACETATE |
17113 | A | II | 1/21/2004 | ASPEN OSS BV | HYDROXYPROGESTERONE CAPROATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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