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Last Updated: March 28, 2024

Drug Master Files for: ketoconazole


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ketoconazole Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10037 A II 1/15/1993 JANSSEN PHARMACEUTICA NV KETOCONAZOLE DRUG SUBSTANCE
10038 I II 1/15/1993 JANSSEN RESEARCH FDN INTERMEDIATES OF KETOCONAZOLE
11579 A II 7/13/1995 ESTEVE QUIMICA SA KETOCONAZOLE
12023 A II 6/25/1996 QUIMICA SINTETICA SA KETOCONAZOLE
12171 I II 10/11/1996 ALBEMARLE CORP KETOCONAZOLE
12794 I II 12/9/1997 QUIMICA FINA FARMEX SA DE CV KETOCONAZOLE
14794 A II 1/19/2001 DERIVADOS QUIMICOS SAU KETOCONAZOLE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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