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Generated: July 15, 2019

DrugPatentWatch Database Preview

Drug Master Files for: ropinirole

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ropinirole Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17880 A II 12/8/2004 URQUIMA SA ROPINIROLE HYDROCHLORIDE
18412 A II 6/9/2005 DR REDDYS LABORATORIES LTD ROPINIROLE HYDROCHLORIDE
18564 A II 7/30/2005 IND SWIFT LABORATORIES LTD ROPINIROLE HYDROCHLORIDE USP
18777 A II 9/14/2005 TORRENT PHARMACEUTICALS LTD ROPINIROLE HYDROCHLORIDE DRUG SUBSTANCE
19045 A II 12/19/2005 USV PRIVATE LTD ROPINIROLE HYDROCHLORIDE USP
19198 I II 2/22/2006 PCAS ROPINIROLE HYDROCHLORIDE
19590 A II 7/10/2006 NEULAND LABORATORIES LTD ROPINIROLE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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