Drug Master Files for: TRANEXAMIC ACID

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TRANEXAMIC ACID Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14181	A	II	5/28/1999	HUNAN DONGTING PHARMACEUTICAL CO LTD	TRANEXAMIC ACID
22277	A	II	12/2/2008	ALP PHARM BEIJING CO LTD	TRANEXAMIC ACID
25331	A	II	9/14/2011	ASAHI KASEI FINECHEM CO LTD	TRANEXAMIC ACID USP
26128	A	II	6/5/2012	KYOWA PHARMA CHEMICAL CO LTD	TRANEXAMIC ACID DRUG SUBSTANCE
33086	A	II	9/5/2018	SHILPA MEDICARE LTD	TRANEXAMIC ACID USP
3864	I	II	7/10/1980	DAIICHI SANKYO CO LTD	TRANEXAMIC ACID
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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