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Last Updated: March 28, 2024

Drug Master Files for: codeine


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codeine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10159 I II 3/24/1993 NORAMCO DELAWARE INC CODEINE SULFATE
10162 I II 3/24/1993 NORAMCO DELAWARE INC CODEINE
12655 I II 9/11/1997 FINE CHEMICALS CORP CODEINE PHOSPHATE
191 A II 1/24/1956 SPECGX LLC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE)
20213 A II 1/29/2007 SIEGFRIED USA LLC CODEINE PHOSPHATE USP
207 I II 5/9/1956 NEW YORK QUININE AND CHEMICAL WORKS INC DIHYDROCODEINE BITARTRATE ANHYDROUS
20787 A II 8/23/2007 JOHNSON MATTHEY PHARMACEUTICAL MATERIALS CODEINE PHOSPHATE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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