Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090722
Company: TORRENT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Discontinued None No No
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Discontinued None No No
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;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
06/20/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/17/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/17/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/17/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/17/2019 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/08/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/08/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

07/25/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/23/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/02/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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