Drug Master Files for: GONADORELIN ACETATE
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GONADORELIN ACETATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10220 | A | II | 5/4/1993 | ASPEN OSS BV | GONADORELIN ACETATE |
| 10878 | I | II | 4/26/1994 | PEPTECH EUROPE AS | GONADORELIN ACETATE |
| 4410 | I | II | 1/7/1982 | HOECHST AG | GONADORELIN BULK DRY SUBSTANCE |
| 5067 | I | II | 8/31/1983 | AYERST LABORATORIES INC DIV AMERICAN HOME PRODUCTS CORP | GONADORELIN HCL |
| 5338 | I | II | 12/7/1983 | DIOSYNTH BV | GONADORELIN ACETATE |
| 6165 | I | II | 12/30/1985 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | GONADORELIN DIACETATE TETRAHYDRATE (GnRH) |
| 7004 | I | II | 6/4/1987 | FERRING GMBH | GONADORELIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
