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Generated: October 16, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Alkermes Inc

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Alkermes Inc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12571 A II 7/9/1997 ALKERMES INC RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS
13957 I II 1/22/1999 ALKERMES INC FLUVOXAMINE MALEATE CR CAPSULES
14028 I II 3/18/1999 ALKERMES INC PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROSPHERE PRODUCTS FOR PRODUCT ADMINISTRATION
16364 I III 1/16/2003 ALKERMES INC C2S DRY POWDER INHALER DRUG DELIVERY SYSTEMS
16433 I II 2/21/2003 ALKERMES INC AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MG
18805 A II 9/26/2005 ALKERMES INC MELOXICAM NANOCRYSTAL? TABLETS
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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