Drug Master Files for: HYDROXYZINE HYDROCHLORIDE

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HYDROXYZINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13852	I	II	11/19/1998	UCB SA PHARMACEUTIQUE SECTEUR	HYDROXYZINE HYDROCHLORIDE COMPACTED
19596	A	II	7/12/2006	SYMED LABS LTD	HYDROXYZINE HYDROCHLORIDE
22042	I	II	10/6/2008	AARTI DRUGS LTD	HYDROXYZINE HYDROCHLORIDE
23283	A	II	4/9/2010	IPCA LABORATORIES LTD	HYDROXYZINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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