Drug Master Files for: omeprazole

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omeprazole Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11017	I	II	8/2/1994	ESTEVE QUIMICA SA	OMEPRAZOLE
11551	A	II	6/9/1995	UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)	OMEPRAZOLE
11794	A	II	12/21/1995	ESTEVE QUIMICA SA	OMEPRAZOLE
12605	A	II	7/23/1997	QUIMICA SINTETICA SA	OMEPRAZOLE
12694	A	II	10/9/1997	ASTRAZENECA AB	PRILOSEC MUPS TABLETS (OMEPRAZOLE MAGNESIUM)
12726	A	II	10/31/1997	ASTRAZENECA AB	OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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