Drug Master Files for: meclizine hydrochloride

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meclizine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19419	A	II	4/28/2006	SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTD	MECLIZINE HYDROCHLORIDE
20470	A	II	4/23/2007	FLEMING LABORATORIES LTD	MECLIZINE HCL USP
21987	A	II	12/5/2008	JUBILANT GENERICS LTD	MECLIZINE HYDROCHLORIDE
22309	A	II	12/11/2008	RA CHEM PHARMA LTD	MECLIZINE HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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