Drug Master Files for: LORATADINE

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LORATADINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11803	A	II	12/19/1995	QUIMICA SINTETICA SA	LORATADINE
12650	A	II	9/11/1997	MOREPEN LABORATORIES LTD	LORATADINE
13032	A	II	6/18/1998	MSD INTERNATIONAL GMBH	LORATADINE
13811	I	II	10/20/1998	INKE SA	LORATADINE
13842	I	II	11/12/1998	MEDICHEM SA	LORATADINE
14155	A	II	5/26/1999	ROLABO OUTSOURCING SL	LORATADINE USP
15251	A	II	1/17/2001	SUN PHARMACEUTICAL INDUSTRIES LTD	LORATADINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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