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Last Updated: November 24, 2024

Drug Master Files for: NEBIVOLOL HYDROCHLORIDE


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NEBIVOLOL HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15417 A II 5/7/2001 JANSSEN PHARMACEUTICA NV NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS
21152 A II 12/8/2007 CADILA PHARMACEUTICALS LTD Nebivolol Hydrochloride
22735 A II 3/31/2009 FIS FABBRICA ITALIANA SINTETICI SPA NEBIVOLOL HYDROCHLORIDE
22906 A II 6/29/2009 TORRENT PHARMACEUTICALS LTD NEBIVOLOL HYDROCHLORIDE
24821 I II 3/31/2011 DR REDDYS LABORATORIES LTD NEBIVOLOL HYDROCHLORIDE
24916 A II 5/4/2011 MSN PHARMACHEM PRIVATE LTD NEBIVOLOL HYDROCHLORIDE[ROUTE CODE: NH]
25296 A II 9/12/2011 HETERO DRUGS LTD NEBIVOLOL HYDROCHLORIDE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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