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Last Updated: March 18, 2024

Drug Master Files for: NORFLOXACIN


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NORFLOXACIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11139 I II 10/13/1994 WYCKOFF CHEMICAL CO INC NORFLOXACIN
11811 A II 1/15/1996 CIPLA LTD NORFLOXACIN USP
19021 I II 12/5/2005 SMRUTHI ORGANICS LTD NORFLOXACIN USP
5195 I II 12/21/1983 KYORIN PHARMACEUTICAL CO LTD NORFLOXACIN
8415 I II 2/6/1990 CIPLA LTD NORFLOXACIN
8490 I II 3/20/1990 QUIMICA SINTETICA SA NORFLOXACIN USP XXII
9360 I II 10/2/1991 CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD NORFLOXACIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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