Drug Master Files for: montelukast sodium

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montelukast sodium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16243	A	II	11/15/2002	DELMAR CHEMICALS INC	MONTELUKAST SODIUM THIOL ACID
19829	A	II	10/4/2006	TEVA PHARMACEUTICAL INDUSTRIES LTD	MONTELUKAST SODIUM
20035	A	II	12/14/2006	DR REDDYS LABORATORIES LTD	MONTELUKAST SODIUM USP
20425	A	II	3/26/2007	MYLAN LABORATORIES LTD	MONTELUKAST SODIUM USP
20564	I	II	5/31/2007	UNIMARK REMEDIES LTD	MONTELUKAST SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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