Drug Master Files for: GANIRELIX ACETATE

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GANIRELIX ACETATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13971	A	II	2/4/1999	ASPEN OSS BV	GANIRELIX,
25866	A	II	3/28/2012	SUN PHARMACEUTICAL INDUSTRIES LTD	GANIRELIX ACETATE
29585	A	II	7/24/2015	BCN PEPTIDES SA	GANIRELIX ACETATE
30800	A	II	7/28/2016	HYBIO PHARMACEUTICAL CO LTD	GANIRELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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