Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076093
Company: LARKEN LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFLOXACIN OFLOXACIN 200MG TABLET;ORAL Discontinued None No No
OFLOXACIN OFLOXACIN 300MG TABLET;ORAL Discontinued None No No
OFLOXACIN OFLOXACIN 400MG 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
09/02/2003 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76093.ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/22/2019 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/18/2018 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/26/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/26/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/22/2014 SUPPL-6 Labeling

Label is not available on this site.

03/05/2015 SUPPL-5 REMS-Modified, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/04/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/22/2005 SUPPL-2 Labeling

Label is not available on this site.

04/05/2005 SUPPL-1 Labeling

Label is not available on this site.

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