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Last Updated: August 5, 2021

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Drug Master Files for: NIFEDIPINE


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NIFEDIPINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10280 I II 6/7/1993 UNIQUE CHEMICALS NIFEDIPINE
11948 A II 4/24/1996 EVONIK NUTRITION AND CARE GMBH NIFEDIPINE
13115 I II 8/7/1998 CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD NIFEDIPINE USP, (BULK A PHARMACEUTICAL INGREDIENT), MANFACTURED IN TAIWAN, THE REPUBLIC OF CHINA
15293 A II 2/15/2001 CATALENT PHARMA SOLUTIONS LLC NIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE
16730 A II 7/29/2003 UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD) NIFEDIPINE USP
23117 A II 9/18/2009 CATALENT PHARMA SOLUTIONS LLC PROCARDIA SOFTGELS 10 MG (NIFEDIPINE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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