Drug Master Files for: MEROPENEM

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MEROPENEM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10321	I	II	6/25/1993	DAINIPPON SUMITOMO PHARMA CO LTD	MEROPENEM/SODIUM CARBONATE
10322	A	II	6/25/1993	SUMITOMO DAINIPPON PHARMA CO LTD	MEROPENEM
18102	A	II	2/16/2005	SUMITOMO DAINIPPON PHARMA CO LTD	MEROPENEM BULK BLEND
21061	A	II	11/23/2007	SAVIOR LIFETEC CORP	Meropenem USP
21194	I	II	12/24/2007	RANBAXY LABORATORIES LTD	Meropenem Technical
21690	A	II	6/27/2008	PFIZER HEALTHCARE INDIA PVT LTD	MPEP (MEROPENEM INTERMEDIATE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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