Drug Master Files for: theophylline

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theophylline Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18896	I	II	10/17/2005	STANDARD CHEM AND PHARM CO LTD	THEOPHYLLINE SODIUM GLYCINATE
1911	I	II	4/4/1972	GANES CHEMICALS INC PENNSVILLE DIV	8 - BROMOTHEOPHYLLINE
20455	A	II	4/19/2007	SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH	THEOPHYLLINE HYDROUS
22481	I	II	2/6/2009	CSPC INNOVATION PHARM CO LTD	THEOPHYLLINE
23244	I	II	11/2/2009	HAINAN POLY PHARMACEUTICAL CO LTD	THEOPHYLLINE EXTENDED RELEASE CAPSULES
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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