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Last Updated: April 23, 2024

Drug Master Files for: Mylan

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Mylan Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10429	A	III	8/18/1993	MYLAN TECHNOLOGIES INC	2226 LINER
11396	I	III	1/16/1995	MYLAN TECHNOLOGIES INC	2229 PEELABLE RELEASE LINER
11404	A	III	3/15/1995	MYLAN TECHNOLOGIES INC	MEDIFLEXr 1200 and MEDIFLEXr 1501
11884	I	IV	3/4/1996	MYLAN TECHNOLOGIES INC	BERTEK CODE 44119 MEDILAM 3600
12011	I	II	6/20/1996	MYLAN INC	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF TRIFLUOROTHYMIDINE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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