Drug Master Files for: Lupin Ltd

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Lupin Ltd Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11291	A	II	1/9/1995	LUPIN LTD	RIFAMYCIN-S (BULK SUBSTANCE)
12086	A	II	8/2/1996	LUPIN LTD	7-ACCA
13214	A	II	4/30/1998	LUPIN LTD	RIFAMPIN USP
13217	I	II	4/30/1998	LUPIN LTD	CEFACLOR USP AS MAUFACTURED IN MANDIDEEP, INDIA
13219	A	II	4/30/1998	LUPIN LTD	STERILE CEFOTAXIME SODIUM 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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