Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078183
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN EXTENDED RELEASE CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6MG;EQ 287.5MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
CIPROFLOXACIN EXTENDED RELEASE CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 425.2MG;EQ 574.9MG BASE 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
03/22/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078183s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/26/2019 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

04/26/2019 SUPPL-18 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/24/2017 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/26/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/18/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/14/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/02/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/13/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/08/2011 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide

Label is not available on this site.

07/21/2009 SUPPL-4 Labeling, REMS-Proposal

Label is not available on this site.

12/02/2008 SUPPL-3 Labeling

Label is not available on this site.

11/28/2007 SUPPL-2 Labeling

Label is not available on this site.

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