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Last Updated: November 7, 2024

Drug Master Files for: CARBINOXAMINE MALEATE


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CARBINOXAMINE MALEATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
21283 I II 1/15/2008 TAI HENG INDUSTRY CO LTD CARBINOXAMINE MALEATE API USP
21301 A II 1/31/2008 MSN PHARMACHEM PRIVATE LTD CARBINOXAMINE MALEATE USP [ROUTE CODE - CX]
21335 I II 2/14/2008 SYMED LABS LTD CARBINOXAMINE MALEATE USP
2962 I II 6/6/1977 TAISHO PHARMACEUTICAL CO LTD CARBINOXAMINE MALEATE
3207 I II 4/28/1978 HEINRICH MACK NACHF CARBINOXAMINE MALEATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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