Drug Master Files for: Biocon Ltd

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Biocon Ltd Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14912	A	II	6/5/2000	BIOCON LTD	LOVASTATIN USP
16048	A	II	7/12/2002	BIOCON LTD	PRAVASTATIN SODIUM USP
16049	A	II	7/12/2002	BIOCON LTD	COMPACTIN
16094	I	II	8/12/2002	BIOCON LTD	SIMVASTATIN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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