Drug Master Files for: praziquantel

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praziquantel Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11631	I	II	8/23/1995	SHANGHAI NUMBER 6 PHARMACEUTICAL FACTORY	PRAZIQUANTEL
13999	A	II	2/24/1999	PCAS	PRAZIQUANTEL
14352	A	II	8/19/1999	CIPLA LTD	PRAZIQUANTEL USP
23887	I	II	6/15/2010	SEQUENT SCIENTIFIC LTD	PRAZIQUANTEL
26076	A	II	5/21/2012	SOLARA A PHARMA SCIENCES LTD	PRAZIQUANTEL
26837	A	II	1/14/2013	SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD	PRAZIQUANTEL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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