Drug Master Files for: GOSERELIN ACETATE

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GOSERELIN ACETATE Drug Master Files

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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
31488	A	II	4/21/2017	ASTRAZENECA PHARMACEUTICALS LP	GOSERELIN ACETATE
31489	A	II	4/21/2017	ASTRAZENECA PHARMACEUTICALS LP	GOSERELIN ACETATE IMPLANT
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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