Drug Master Files for: TESTOSTERONE ENANTHATE

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TESTOSTERONE ENANTHATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11826	A	II	1/3/1996	ASPEN OSS BV	TESTOSTERONE
14540	A	II	11/18/1999	ASPEN OSS BV	TESTOSTERONE UNDECANOATE
15077	A	II	10/2/2000	BAYER AG	TESTOSTERONE
16136	I	II	9/16/2002	3M PHARMACEUTICALS SBC	TESTOSTERONE/ESTRADIOL TRANSDERMAL DELIVERY SYSTEMS CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) AND TOXICOLOGY
16795	A	II	8/15/2003	BAYER AG	TESTOSTERONE UNDECANOATE
16809	A	II	8/15/2003	BAYER AG	TESTOSTERONE UNDECANOATE 750 MG I.M.
18804	I	II	9/19/2005	HENAN QUANXIN MEDICAL CHEMICAL TECHNOLOGY CO LTD	METHYLTESTOSTERONE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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