Drug Master Files for: tirofiban hydrochloride

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tirofiban hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23173	A	II	10/7/2009	GLAND PHARMA LTD	TIROFIBAN HYDROCHLORIDE
26942	I	II	3/14/2013	WISDOM PHARMACEUTICAL CO LTD	TIROFIBAN HYDROCHLORIDE
27293	A	II	7/3/2013	FARMABIOS SPA	TIROFIBAN HYDROCHLORIDE MONOHYDRATE
32701	A	II	4/13/2018	WISDOM PHARMACEUTICAL CO LTD	TIROFIBAN HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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