Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Baxter
Fuji
Cantor Fitzgerald
Boehringer Ingelheim
McKinsey

Generated: July 18, 2019

DrugPatentWatch Database Preview

Drug Master Files for: sotalol

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sotalol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11887 I II 3/6/1996 IROTEC LABORATORIES SOTALOL HYDROCHLORIDE
12273 A II 12/17/1996 CAMBREX PROFARMACO MILANO SRL SOTALOL HCL
13083 I II 7/21/1998 ERREGIERRE SPA SOTALOL HYDROCHLORIDE
13186 I II 9/14/1998 HEUMANN PHARMA GMBH SOTALOL HYDROCHLORIDE
13992 A II 2/22/1999 MOEHS IBERICA SL SOTALOL HCI
14841 I II 4/20/2000 SIFAVITOR SRL SOTALOL HYDROCHLORIDE
14951 A II 7/13/2000 NEULAND LABORATORIES LTD SOTALOL 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Express Scripts
Moodys
Teva
Fuji
Colorcon
Fish and Richardson

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