Drug Master Files for: TIGECYCLINE

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TIGECYCLINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22247	A	II	11/29/2008	UNIMARK REMEDIES LTD	TIGECYCLINE TECHNICAL
22767	A	II	5/11/2009	TEVA PHARMACEUTICAL INDUSTRIES LTD	TIGECYCLINE
22841	A	II	6/9/2009	SANDOZ PRIVATE LTD	TIGECYCLINE HYDROCHLORIDE
25935	A	II	5/19/2012	GLAND PHARMA LTD	TIGECYCLINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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