Drug Master Files for: desogestrel
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desogestrel Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11555 | I | II | 6/12/1995 | ORGANON NV | DESOGESTREL TABLETS (75UG AND 150UG) |
| 12368 | A | II | 2/18/1997 | GEDEON RICHTER PLC | DESOGESTREL |
| 15771 | A | II | 12/17/2001 | INDUSTRIALE CHIMICA SRL | DESOGESTREL |
| 16389 | A | II | 1/25/2003 | EUTICALS SPA | DESOGESTREL |
| 23619 | A | II | 4/12/2010 | LUPIN LTD | DESOGESTREL |
| 23652 | A | II | 3/24/2010 | INDUSTRIALE CHIMICA SRL | DESOGESTREL CN |
| 28124 | A | II | 3/17/2014 | SYMBIOTEC PHARMALAB PRIVATE LTD | DESOGESTREL EP/BP, 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
