Drug Master Files for: ROPINIROLE HYDROCHLORIDE

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ROPINIROLE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17880	A	II	12/8/2004	URQUIMA SA	ROPINIROLE HYDROCHLORIDE
18412	A	II	6/9/2005	DR REDDYS LABORATORIES LTD	ROPINIROLE HYDROCHLORIDE
18564	A	II	7/30/2005	IND SWIFT LABORATORIES LTD	ROPINIROLE HYDROCHLORIDE USP
18777	A	II	9/14/2005	TORRENT PHARMACEUTICALS LTD	ROPINIROLE HYDROCHLORIDE DRUG SUBSTANCE
19045	A	II	12/19/2005	USV PRIVATE LTD	ROPINIROLE HYDROCHLORIDE USP
19198	I	II	2/22/2006	PCAS	ROPINIROLE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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