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Last Updated: August 3, 2020

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Drug Master Files for: CETIRIZINE HYDROCHLORIDE

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CETIRIZINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15145 A II 11/17/2000 CIPLA LTD CETIRIZINE DIHYDROCHLORIDE USP
15219 I II 12/22/2000 CAMBREX CHARLES CITY INC CETIRIZINE DIHYDROCHLORIDE
16244 A II 11/14/2002 WAVELENGTH ENTERPRISES LTD CETIRIZINE DIHYDROCHLORIDE
16262 A II 11/27/2002 TARO PHARMACEUTICAL INDUSTRIES LTD CETIRIZINE DIHYDROCHLORIDE USP
17513 A II 6/18/2004 UCB FARCHIM SA CETIRIZINE HYDROCHLORIDE
17741 A II 10/8/2004 MYLAN LABORATORIES LTD CETIRIZINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

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