Drug Master Files for: CELECOXIB

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CELECOXIB Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14929	I	II	6/20/2000	NANO SYSTEMS	CELECOXIB 200 MG FILM COATED TABLETS
16671	A	II	6/30/2003	CIPLA LTD	CELECOXIB USP
17697	A	II	9/22/2004	MYLAN LABORATORIES LTD	CELECOXIB 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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