Drug Master Files for: CYCLOBENZAPRINE HYDROCHLORIDE

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CYCLOBENZAPRINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18317	A	II	4/27/2005	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	CYCLOBENZAPRINE HYDROCHLORIDE
21392	A	II	3/5/2008	HETERO DRUGS LTD	CYCLOBENZAPRINE HYDROCHLORIDE
21779	A	II	7/8/2008	VASUDHA PHARMA CHEM LTD	CYCLOBENZAPRINE HCL USP
23063	I	II	8/19/2009	FLEMING LABORATORIES LTD	CYCLOBENZAPRINE HYDROCHLORIDE USP BULK
23521	A	II	2/5/2010	DERIVADOS QUIMICOS SAU	CYCLOBENZAPRINE HYDROCHLORIDE
24719	A	II	3/26/2011	JUBILANT GENERICS LTD	CYCLOBENZAPRINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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