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Last Updated: March 29, 2024

Drug Master Files for: triple


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triple Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14580 I IV 11/15/1999 FONA INTERNATIONAL INC 807.120 N-C TRIPLEBERRY FLAVOR ARTIFICIAL
29307 A III 4/18/2015 YEN FLEXI PACK TRIPLE LAMINATED BAGS FOR PHARMACEUTICAL USE
32045 A III 9/1/2017 FLEXIFOIL PACKAGING PVT LTD PLAIN, PRINTED, COATED, LAMINATED ALUMINIUM FOIL, COLD FORMING FOILS, CR FOILS, TROPICAL BLISTERS, TRIPLE LAMINATED POUCHES, BAGS, MULTILAYER LAMINATED FILMS &
32497 A III 2/8/2018 UNIWORTH ENTERPRISES LLP TRIPLEX (PVC/PE/PVDC) FILMS
6411 I II 6/12/1986 MERCK KGAA TITRIPLEX VS, DIETHYLENETRIAMINEPENTAACETIC ACID
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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