Drug Master Files for: prasugrel hydrochloride

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prasugrel hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25328	A	II	10/21/2011	DR REDDYS LABORATORIES LTD	PRASUGREL HYDROCHLORIDE
25651	A	II	12/30/2011	MYLAN LABORATORIES LTD	PRASUGREL HYDROCHLORIDE
25898	A	II	3/21/2012	ALEMBIC PHARMACEUTICALS LTD	PRASUGREL HYDROCHLORIDE
26769	A	II	12/28/2012	HEC PHARM CO LTD	PRASUGREL HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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