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Generated: December 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Mallinckrodt

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Mallinckrodt Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10543 I II 10/26/1993 MALLINCKRODT CHEMICAL INC BRAIN NATRIURETIC PEPTIDE
11227 I II 12/1/1994 MALLINCKRODT CHEMICAL INC SODIUM HYDROGEN L-TARTRATE
1133 I II 1/24/1968 MALLINCKRODT INC DIATRIZOIC ACID
11529 I II 7/6/1995 MALLINCKRODT INC MORPHINE SULFATE INJECTION USP
11636 I II 8/30/1995 MALLINCKRODT INC MEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chubb
AstraZeneca
UBS
Mallinckrodt
Covington
Teva
Fuji
Baxter

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