Drug Master Files for: ERTAPENEM SODIUM

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ERTAPENEM SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
27348	A	II	9/24/2013	PFIZER HEALTHCARE INDIA PVT LTD	ERTAPENEM SODIUM
28391	A	II	6/16/2014	SOLARA A PHARMA SCIENCES LTD	ERTAPENEM SODIUM
29102	A	II	4/13/2015	ACS DOBFAR SPA	ERTAPENEM SODIUM
29473	I	II	6/12/2015	ASYMCHEM LABORATORIES FUXIN CO LTD	ERTAPENEM SODIUM
30123	A	II	1/7/2016	SUN PHARMACEUTICAL INDUSTRIES LTD	ERTAPENEM 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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