Drug Master Files for: DORIPENEM

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DORIPENEM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25239	I	II	11/7/2011	HOSPIRA HEALTHCARE INDIA PVT LTD	DORIPENEM (STERILE)
25372	I	II	10/10/2011	SANDOZ PRIVATE LTD	DORIPENEM MONOHYDRATE, STERILE
28210	A	II	4/25/2014	UNIMARK REMEDIES LTD	DORIPENEM CRUDE (INTERMEDIATE)
28212	I	II	5/3/2014	AURONEXT PHARMA PRIVATE LTD	DORIPENEM MONOHYDRATE (STERILE)
28280	A	II	5/30/2014	UNIMARK REMEDIES LTD	DORIPENEM STERILE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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