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Generated: September 18, 2019

DrugPatentWatch Database Preview

Drug Master Files for: dobutamine

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dobutamine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10097 I II 2/11/1993 EGIS PHARMACEUTICALS PRIVATE LTD DOBUTAMINE HYDROCHLORIDE
10296 I II 6/14/1993 CHEMSYN SCIENCE LABORATORIES DOBUTAMINE HYDROCHLORIDE
10706 I II 1/28/1994 IROTEC LABORATORIES DOBUTAMINE HYDROCHLORIDE
11023 A II 8/2/1994 SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH DOBUTAMINE HYDROCHLORIDE
11083 I II 9/15/1994 SOCHINAZ SA DOBUTAMINE HCL
12528 I II 5/30/1997 HOECHST MARION ROUSSEL SA DOBUTAMINE ISONICOTINATE/ OFF-0358-A-01-1
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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