Drug Master Files for: FAMOTIDINE

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FAMOTIDINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11537	A	II	6/5/1995	GEDEON RICHTER PLC	FAMOTIDINE, USP
13036	A	II	6/17/1998	QUIMICA SINTETICA SA	FAMOTIDINE
13086	A	II	7/21/1998	ERCROS SA	FAMOTIDINE
14309	A	II	7/22/1999	DR REDDYS LABORATORIES LTD	FAMOTIDINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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