Drug Master Files for: TEMAZEPAM

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TEMAZEPAM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23160	A	II	10/5/2009	MYLAN LABORATORIES LTD	TEMAZEPAM USP
25364	A	II	10/3/2011	CENTAUR PHARMACEUTICALS PVT LTD	TEMAZEPAM USP
3193	I	II	4/5/1978	WYETH INC	TEMAZEPAM
4376	A	II	11/12/1981	CAMBREX PROFARMACO MILANO SRL	TEMAZEPAM
5223	A	II	12/16/1983	FIS FABBRICA ITALIANA SINTETICI SPA	TEMAZEPAM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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