Drug Master Files for: NICARDIPINE HYDROCHLORIDE

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NICARDIPINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10104	A	II	2/19/1993	OLON SPA	NICARDIPINE HYDROCHLORIDE
10702	I	II	1/25/1994	MITSUBISHI CORP	NICARDIPINE HYDROCHLORIDE
19552	A	II	6/26/2006	CHEMWERTH INC	NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE
19773	A	II	9/15/2006	NAVINTA LLC	NICARDIPINE HYDROCHLORIDE
21211	A	II	12/31/2007	WOCKHARDT LTD	NICARDIPINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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