Drug Master Files for: CETIRIZINE HYDROCHLORIDE

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CETIRIZINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15145	A	II	11/17/2000	CIPLA LTD	CETIRIZINE DIHYDROCHLORIDE USP
15219	I	II	12/22/2000	CAMBREX CHARLES CITY INC	CETIRIZINE DIHYDROCHLORIDE
16244	A	II	11/14/2002	WAVELENGTH ENTERPRISES LTD	CETIRIZINE DIHYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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