Drug Master Files for: ranitidine hydrochloride

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ranitidine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10273	A	II	5/27/1993	UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)	RANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM 1)
10516	I	II	10/5/1993	RANBAXY LABORATORIES LTD	RANITIDINE HYDROCHLORIDE
10682	I	II	12/15/1993	CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD	RANITIDINE HYDROCHLORIDE
10885	I	II	4/25/1994	NOVOPHARM LTD	RANITIDINE HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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