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McKinsey
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Generated: June 18, 2019

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Drug Master Files for: PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

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PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10883 I II 4/19/1994 EURAND SPA PANCRELIPASE (ULTRASE) MINITABS
12032 I II 7/5/1996 NORDMARK ARZNEIMITTEL GMBH PANCRELIPASE ENTERIC COATED MICROTABLETS
15447 I II 5/15/2001 YUNG SHIN PHARMACEUTICAL INDUSTRIES CO LTD PANCRELIPASE CR PELLETS
15681 A II 10/15/2001 ADARE PHARMACEUTICALS SRL PANCRELIPASE PRODUCTS (EURAND MINITABS) (HP55)
7090 A II 7/28/1987 NORDMARK ARZNEIMITTEL GMBH AND CO KG PANCRELIPASE
9649 A II 4/9/1992 SCIENTIFIC PROTEIN LABORATORIES LLC PANCREATIN/ PANCRELIPASE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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