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Last Updated: December 13, 2019

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Drug Master Files for: methadone

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methadone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13942 I II 1/18/1999 BOEHRINGER INGELHEIM CHEMICALS INC METHADONE HYDROCHLORIDE USP
1508 I II 3/25/1970 LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO 1-METHADONE HYDROCHLORIDE
1515 I II 4/23/1970 MALLINCKRODT INC METHADONE HYDROCHLORIDE
1526 I II 5/27/1970 ELI LILLY AND CO MANUF AND CONTROL INFOR. FOR METHADONE HYDROCHLORIDE DISPERSIBLE TBLS
1607 I II 11/28/1970 VITARINE CO INC SUB WEST CHEMICAL PRODUCTS INC METHADONE HCL EFFERVESCENT TABLETS, 40MG
1802 I II 9/21/1971 MALLINCKRODT INC METHADONE HCL FLAVORED CONCENTRATE
2224 I II 1/28/1974 ADAMHA NIDA METHADONE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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