Drug Master Files for: HYDRALAZINE HYDROCHLORIDE

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HYDRALAZINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1909	I	II	3/27/1972	ALLIED CHEMICAL CORP	HYDRALAZINE HCL
19209	I	II	2/10/2006	SHANDONG WEIFANG PHARMACEUTICAL FACTORY CO LTD	HYDRALAZINE HYDROCHLORIDE (NON-STERILE A PHARMACEUTICAL INGREDIENT)
19904	A	II	10/26/2006	NAVINTA LLC	HYDRALAZINE HYDROCHLORIDE USP
20520	A	II	5/9/2007	HETERO LABS LTD	HYDRALAZINE HYDROCHLORIDE
21953	I	II	9/5/2008	DK PHARMA CHEM PVT LTD	HYDRALAZINE HYDROCHLORIDE USP
22169	A	II	10/31/2008	EUTICALS SPA	HYDRALAZINE HYDROCHLORIDE
22633	A	II	3/16/2009	SOLARA A PHARMA SCIENCES LTD	HYDRALAZINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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