Drug Master Files for: AMLODIPINE BESYLATE

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AMLODIPINE BESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15127	I	II	11/2/2000	ESTEVE QUIMICA SA	AMLODIPINE BESILATE
15746	I	II	12/3/2001	DR REDDYS LABORATORIES LTD	AMLODIPINE MALEATE
15777	A	II	12/21/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	AMLODIPINE BESYLATE
16473	A	II	3/19/2003	DR REDDYS LABORATORIES LTD	AMLODIPINE BESILATE USP
16478	I	II	3/18/2003	HETERO DRUGS LTD	AMLODIPINE BESILATE
16509	A	II	4/1/2003	UNICHEM LABORATORIES LTD	AMLODIPINE BESILATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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