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Last Updated: March 28, 2024

Drug Master Files for: rizatriptan benzoate


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rizatriptan benzoate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17633 I II 8/30/2004 CIPLA LTD RIZATRIPTAN BENZOATE
18021 A II 1/26/2005 CIPLA LTD RIZATRIPTAN BENZOATE USP
19098 A II 1/10/2006 MYLAN LABORATORIES LTD RIZATRIPTAN BENZOATE USP
19179 A II 2/14/2006 DR REDDYS LABORATORIES LTD RIZATRIPTAN BENZOATE USP
20781 A II 8/21/2007 NATCO PHARMA LTD RIZATRIPTAN BENZOATE
22676 A II 3/31/2009 GLENMARK PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE USP
22763 A II 5/8/2009 NATCO PHARMA LTD RIZATRIPTAN BENZOATE (ROUTE - 2; PRODUCT CODE: RTB)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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