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Last Updated: March 18, 2024

Drug Master Files for: GATIFLOXACIN


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GATIFLOXACIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13902 I II 12/18/1998 KYORIN PHARMACEUTICAL CO LTD GATIFLOXACIN
13905 I II 12/21/1998 HOSPIRA INC TEQUIN I.V. (GATIFLOXACIN)
15597 A II 8/27/2001 KYORIN PHARMACEUTICAL CO LTD GATIFLOXACIN DRUG SUBSTANCE
15599 I II 8/27/2001 IHARA CHEMICAL INDUSTRY CO LTD MKS-1 (AS INTERMEDIATE OF GATIFLOXACIN)
16965 I II 11/17/2003 TEVA GROUP GATIFLOXACIN
17002 I II 12/3/2003 CADILA HEALTHCARE LTD GATIFLOXACIN ANHYDROUS
17012 A II 12/2/2003 DR REDDYS LABORATORIES LTD GATIFLOXACIN ANHYDROUS
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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