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Last Updated: July 23, 2021

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Drug Master Files for: HYDROXYZINE HYDROCHLORIDE


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HYDROXYZINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13852 I II 11/19/1998 UCB SA PHARMACEUTIQUE SECTEUR HYDROXYZINE HYDROCHLORIDE COMPACTED
19596 A II 7/12/2006 SYMED LABS LTD HYDROXYZINE HYDROCHLORIDE
22042 I II 10/6/2008 AARTI DRUGS LTD HYDROXYZINE HYDROCHLORIDE
23283 A II 4/9/2010 IPCA LABORATORIES LTD HYDROXYZINE HYDROCHLORIDE USP
24002 A II 7/22/2010 CALYX CHEMICALS AND PHARMACEUTICALS LTD HYDROXYZINE HYDROCHLORIDE
2807 I II 11/22/1976 INDUSTRIA CHIMICA PROFARMACO SPA HYDROXYZINE HCL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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