Drug Master Files for: OSELTAMIVIR PHOSPHATE

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OSELTAMIVIR PHOSPHATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21557	A	II	5/29/2008	CIPLA LTD	OSELTAMIVIR PHOSPHATE USP
22926	A	II	7/8/2009	SOLARA A PHARMA SCIENCES LTD	OSELTAMIVIR PHOSPHATE
23889	A	II	6/15/2010	MSN PHARMACHEM PRIVATE LTD	OSELTAMIVIR PHOSPHATE [ROUTE CODE - OT]
27533	A	II	9/29/2013	MACLEODS PHARMACEUTICALS LTD	OSELTAMIVIR PHOSPHATE
30012	A	II	11/30/2015	MYLAN LABORATORIES LTD	OSELTAMIVIR PHOSPHATE USP
30253	A	II	4/13/2016	LUPIN LTD	OSELTAMIVIR PHOSPHATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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