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Last Updated: August 3, 2020

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Drug Master Files for: pilocarpine

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pilocarpine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10025 A II 12/28/1992 ANIDRO DO BRASIL EXTRACOES SA PILOCARPINE HYDROCHLORIDE USP
10861 I II 2/28/1994 PVP SOCIEDADE ANONIMA PILOCARPINE HYDROCHLORIDE
11029 I II 8/10/1994 PVP SOCIEDADE ANONIMA PILOCARPINE NITRATE
12388 A II 2/21/1997 IWAKI SEIYAKU CO LTD PILOCARPINE HYDROCHLORIDE
12629 I II 8/15/1997 VEGEFLORA EXTRACOES DO NORDESTE LTDA PILOCARPINE USP
16873 A II 9/25/2003 SOURCETECH QUIMICA LTDA PILOCARPINE HYDROCHLORIDE
4775 I II 12/6/1982 PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKS PILOCARPINE (SOLUTION IN ACETONE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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