Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211291
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/31/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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