Drug Master Files for: Hetero Labs Ltd

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Hetero Labs Ltd Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17507	A	II	7/2/2004	HETERO LABS LTD	IRBESARTAN (FORM A) PROCESS I
17738	A	II	10/7/2004	HETERO LABS LTD	LEVETIRACETAM (FORM 1)
17782	A	II	10/26/2004	HETERO LABS LTD	NEVIRAPINE
17960	A	II	12/29/2004	HETERO LABS LTD	ESCITALOPRAM OXALATE (PROCESS-I)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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