Drug Master Files for: HYDROXYPROGESTERONE CAPROATE
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HYDROXYPROGESTERONE CAPROATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17113 | A | II | 1/21/2004 | ASPEN OSS BV | HYDROXYPROGESTERONE CAPROATE |
2856 | I | II | 2/16/1977 | UPJOHN CO | HYDROXYPROGESTERONE CAPROATE |
28958 | A | II | 2/6/2015 | SUN PHARMACEUTICAL INDUSTRIES LTD | HYDROXYPROGESTERONE CAPROATE USP |
29030 | A | II | 1/20/2015 | SYMBIOTEC PHARMALAB PRIVATE LTD | 17-a HYDROXYPROGESTERONE (INTERMEDIATE) |
2993 | I | II | 7/18/1977 | DIOSYNTH BV | HYDROXYPROGESTERONE CAPROATE |
30747 | A | II | 7/19/2016 | SYMBIOTEC PHARMALAB PRIVATE LTD | HYDROXYPROGESTERONE CAPROATE USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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