Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076182
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFLOXACIN OFLOXACIN 200MG TABLET;ORAL Prescription AB No No
OFLOXACIN OFLOXACIN 300MG TABLET;ORAL Prescription AB No No
OFLOXACIN OFLOXACIN 400MG TABLET;ORAL Prescription AB No Yes
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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/30/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/26/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/10/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf
08/14/2013 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/14/2013 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf
08/13/2013 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified

Label is not available on this site.

03/10/2011 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/13/2013 SUPPL-9 REMS-Modified

Label is not available on this site.

04/21/2010 SUPPL-8 REMS-Proposal, Labeling

Label is not available on this site.

12/19/2008 SUPPL-7 Labeling

Label is not available on this site.

04/25/2008 SUPPL-6 Labeling

Label is not available on this site.

02/06/2008 SUPPL-5 Labeling

Label is not available on this site.

03/16/2007 SUPPL-4 Labeling

Label is not available on this site.

10/17/2006 SUPPL-3 Labeling

Label is not available on this site.

08/30/2005 SUPPL-2 Labeling

Label is not available on this site.

04/08/2005 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/10/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf
08/14/2013 SUPPL-12 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf
08/14/2013 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf

OFLOXACIN

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OFLOXACIN OFLOXACIN 200MG TABLET;ORAL Prescription No AB 091656 CADILA PHARMS LTD
OFLOXACIN OFLOXACIN 200MG TABLET;ORAL Prescription No AB 077098 DR REDDYS LABS LTD
OFLOXACIN OFLOXACIN 200MG TABLET;ORAL Prescription No AB 076182 TEVA

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OFLOXACIN OFLOXACIN 300MG TABLET;ORAL Prescription No AB 091656 CADILA PHARMS LTD
OFLOXACIN OFLOXACIN 300MG TABLET;ORAL Prescription No AB 077098 DR REDDYS LABS LTD
OFLOXACIN OFLOXACIN 300MG TABLET;ORAL Prescription No AB 076182 TEVA

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OFLOXACIN OFLOXACIN 400MG TABLET;ORAL Prescription No AB 091656 CADILA PHARMS LTD
OFLOXACIN OFLOXACIN 400MG TABLET;ORAL Prescription No AB 077098 DR REDDYS LABS LTD
OFLOXACIN OFLOXACIN 400MG TABLET;ORAL Prescription No AB 076182 TEVA

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