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Generated: September 20, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Vale

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Vale Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1041 I II 3/15/1967 VALE CHEMICAL CO INC FACILITIES, METHODS AND PERSONNEL
10513 A II 10/5/1993 VALEANT PHARMACEUTICALS NORTH AMERICA LLC PIRBUTEROL ACETATE
10689 I III 1/20/1994 COVALENCE COATED PRODUCTS PRODUCT 41727-34
11694 I III 10/4/1995 COVALENCE COATED PRODUCTS PROCEDURES FOR STERILE OPERATIONS IN CATALENT BELGIUM LOCATED IN BRUSSELS BELGIUM
13151 I II 8/24/1998 VALEANT PHARMACEUTICALS NORTH AMERICA MOGADON (NITRAZEPAM) TABLETS
15796 I III 12/13/2001 COVALENCE COATED PRODUCTS PRODUCT 24-1-064
18994 A II 12/2/2005 VALEANT PHARMACEUTICALS NORTH AMERICA LLC METFORMIN AQ 1000 MG EXTENDED RELEASE TABLETS
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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