Drug Master Files for: MILNACIPRAN HYDROCHLORIDE

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MILNACIPRAN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11501	A	II	5/11/1995	PIERRE FABRE MEDICAMENT	MILNACIPRAN HYDROCHLORIDE (PROCESS I)
22351	A	II	12/22/2008	PIERRE FABRE MEDICAMENT	LEVOMILNACIPRAN
22741	I	II	4/23/2009	SUN PHARMACEUTICAL INDUSTRIES LTD	MILNACIPRAN HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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