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Last Updated: November 4, 2024

Drug Master Files for: HYDRALAZINE HYDROCHLORIDE


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HYDRALAZINE HYDROCHLORIDE Drug Master Files

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
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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