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Last Updated: November 22, 2024

Drug Master Files for: AMINOCAPROIC ACID


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AMINOCAPROIC ACID Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1039 I II 3/9/1967 NAFTONE INC 6-AMINOCAPROIC ACID
30439 A II 3/24/2016 SUNNY PHARMTECH INC AMINOCAPROIC ACID, USP
31132 A II 12/14/2016 DIPHARMA FRANCIS SRL AMINOCAPROIC ACID
31478 A II 4/26/2017 BIOPHORE INDIA PHARMACEUTICALS PVT LTD AMINOCAPROIC ACID
33134 A II 9/29/2018 MSN LIFE SCIENCES PRIVATE LTD AMINOCAPROIC ACID USP
33407 A II 12/19/2018 OPTIMUS DRUGS PRIVATE LTD AMINOCAPROIC ACID
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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