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Generated: November 13, 2018

DrugPatentWatch Database Preview

Drug Master Files for: norethindrone

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norethindrone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10185 A II 4/12/1993 ASPEN OSS BV NORETHINDRONE ACETATE
10542 I II 10/25/1993 CYGNUS INC ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM
1084 I II 9/13/1967 SYNTEX USA INC NORETHINDRONE ACETATE
1846 I II 12/22/1971 ROUSSEL CORP NORETHINDRONE ACETATE
1920 I II 4/17/1972 ROUSSEL CORP NORETHINDRONE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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