Last Updated: November 10, 2026

Drug Master Files for: GONADORELIN ACETATE

GONADORELIN ACETATE Drug Master Files

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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)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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