Drug Master Files for: BROMPHENIRAMINE MALEATE

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BROMPHENIRAMINE MALEATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15711	I	II	11/8/2001	LC UNITED CHEMICAL CORP	BROMPHENIRAMINE
20604	I	II	6/12/2007	GRANULES INDIA LTD	BROMPHENIRAMINE MALEATE USP
21662	A	II	5/21/2008	KESHAVA ORGANICS PVT LTD	BROMPHENIRAMINE MALEATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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