Drug Master Files for: norgestrel
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norgestrel Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10218 | A | II | 5/4/1993 | BAYER OY | NORPLANT (LEVONORGESTREL IMPLANTS) |
| 12934 | I | II | 3/20/1998 | YANGZHOU PHARMACEUTICAL FACTORY | LEVONORGESTREL USP 23 |
| 12994 | I | II | 5/18/1998 | HUBEI PHARMACEUTICAL FACTORY | LEVONORGESTREL, USP |
| 14288 | I | II | 7/12/1999 | HOECHST MARION ROUSSEL | LEVONORGESTREL |
| 14923 | A | II | 6/16/2000 | 3M DRUG DELIVERY SYSTEMS | CLIMARA PRO(R) ESTRADIOL/LEVONORGESTREL TRANSDERMAL DELIVERY SYSTEM |
| 16271 | A | II | 11/26/2002 | GADOR SA | NORGESTIMATE- DEXNORGESTREL ACETIME |
| 16696 | A | II | 7/7/2003 | INDUSTRIALE CHIMICA SRL | LEVONORGESTREL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
