Drug Master Files for: PRASTERONE
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PRASTERONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 24216 | A | II | 9/17/2010 | PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINA | PRASTERONE (DEHYDROEPIANDROSTERONE) |
| 24438 | A | II | 12/10/2010 | JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP LTD | PRASTERONE ACETATE |
| 27340 | A | II | 9/20/2013 | FIS FABBRICA ITALIANA SINTETICI SPA | PRASTERONE ACETATE |
| 28254 | A | II | 4/25/2014 | ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTD | PRASTERONE ACETATE |
| 28729 | A | II | 12/11/2014 | PFIZER INC | PRASTERONE ACETATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
