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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Boehringer Ingelheim
Baxter
AstraZeneca
Queensland Health
Medtronic
Colorcon
Moodys

Generated: April 24, 2018

DrugPatentWatch Database Preview

Drug Master Files for: dyclonine

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dyclonine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
3014 I 8/5/1977 BURDICK & JACKSON LABS,INC DYCLONINE HYDROCHLORIDE
4032 I II 12/23/1980 GANES CHEMICALS INC PENNSVILLE DIV DYCLONINE HCL
19497 A II 3/31/2006 CHEMPACIFIC CORP DYCLONINE HYDROCHLORIDE DRUG SUBSTANCE
28587 A II 2/18/2015 APAC PHARMACEUTICAL LLC DYCLONINE HYDROCHLORIDE USP
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Teva
McKinsey
QuintilesIMS
Cantor Fitzgerald
Argus Health
Harvard Business School
Dow
Federal Trade Commission
Mallinckrodt

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