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Generated: September 19, 2019

DrugPatentWatch Database Preview

Drug Master Files for: naproxen

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naproxen Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11627 I II 6/4/1996 FARCHEMIA SRL NAPROXEN SODIUM USP
11828 A II 1/26/1996 CORDEN PHARMA BERGAMO SPA NAPROXEN USP
11939 I II 4/23/1996 ALBEMARLE CORP NAPROXEN (RACEMIC)
11940 I II 4/25/1996 ALBEMARLE CORP NAPROXEN SODIUM
11941 I II 4/25/1996 ALBEMARLE CORP NAPROXEN
12341 A II 1/28/1997 DR REDDYS LABORATORIES LTD NAPROXEN
12342 A II 1/28/1997 DR REDDYS LABORATORIES LTD NAPROXEN SODIUM
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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