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Last Updated: November 22, 2024

Drug Master Files for: propantheline bromide


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propantheline bromide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17140 A II 2/6/2004 TOKUYAMA CORP PROPANTHELINE BROMIDE
1950 I 6/14/1972 ACETO CHEMICAL CO INC PROPANTHELINE BROMIDE BULK
2321 I II 8/26/1974 GANES CHEMICALS INC PENNSVILLE DIV PROPANTHELINE BROMIDE
3603 I II 9/11/1979 ERCOPHARM PROPANTHELINE BROMIDE
6469 I II 6/15/1986 HEXAGON LABORATORIES INC PROPANTHELINE BROMIDE
6633 I II 10/14/1986 TOKUYAMA CORP FACILITIES PRODUCING PROPANTHELINE BROMIDE
7691 I II 9/26/1988 CHEMWERTH INC PROPANTHELINE BROMIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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