Drug Master Files for: GOSERELIN ACETATE
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GOSERELIN ACETATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11172 | I | I | 10/28/1994 | ZENECA LTD | MANUFACTURING SITE, FACILITY, PERSONNEL AND GENERAL OPERATING PROCEDURES OF THE GOSERELIN BULK DRUG PLANT IN MACCLESFIELD, CHESHIRE, U.K. |
17768 | A | II | 10/18/2004 | CHEMI SPA | GOSERELIN ACETATE |
29713 | A | II | 9/10/2015 | ALP PHARM BEIJING CO LTD | GOSERELIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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