Drug Master Files for: norethindrone acetate
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norethindrone acetate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10185 | A | II | 4/12/1993 | ASPEN OSS BV | NORETHINDRONE ACETATE |
| 10542 | I | II | 10/25/1993 | CYGNUS INC | ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM |
| 1084 | I | II | 9/13/1967 | SYNTEX USA INC | NORETHINDRONE ACETATE |
| 1846 | I | II | 12/22/1971 | ROUSSEL CORP | NORETHINDRONE ACETATE |
| 1920 | I | II | 4/17/1972 | ROUSSEL CORP | NORETHINDRONE |
| 20004 | A | II | 11/30/2006 | GADOR SA | 17-METHYLNORETHINDRONE OXIME (NORELGESTROMIN) |
| 2033 | A | II | 12/22/1972 | BAYER AG | NORETHINDRONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
