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Last Updated: March 5, 2021

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Drug Master Files for: paroxetine

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paroxetine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12770 I II 12/3/1997 APOTEX PHARMACHEM INC PAROXETINE HYDROCHLORIDE (ANHYDROUS)
13888 I II 12/7/1998 SUMITOMO CHEMICAL CO LTD PAROXETINE HYDROCHLORIDE ANHYDRATE
14432 I II 9/30/1999 ASAHI GLASS CO LTD PAROXETINE HYDROCHLORIDE AMORPHOUS
14475 I II 10/13/1999 GLAXOSMITHKLINE PAROXETINE HYDROCHLORIDE HEMIHYDRATE
14913 A II 6/1/2000 AESICA PHARMACEUTICALS LTD PAROXETINE HYDROCHLORIDE
15039 A II 9/15/2000 GLAXOSMITHKLINE PAROXETINE HYDROCHLORIDE HEMIHYDRATE
15463 I II 5/29/2001 CHEMI SPA PAROXETINE ACETATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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