Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075817
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Discontinued None No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Discontinued None No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription AB No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE 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
06/09/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75817.ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/12/2015 SUPPL-33 Labeling-Container/Carton Labels

Label is not available on this site.

07/02/2015 SUPPL-32 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/02/2015 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

10/25/2013 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

10/25/2013 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

05/16/2011 SUPPL-25 Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide

Label is not available on this site.

05/19/2010 SUPPL-22 REMS-Modified, Labeling-Container/Carton Labels

Label is not available on this site.

05/10/2010 SUPPL-19 Labeling-Container/Carton Labels

Label is not available on this site.

07/22/2009 SUPPL-17 Labeling, REMS-Proposal

Label is not available on this site.

08/12/2014 SUPPL-15 Labeling

Label is not available on this site.

12/04/2008 SUPPL-11 Labeling

Label is not available on this site.

09/16/2008 SUPPL-9 Labeling

Label is not available on this site.

06/25/2007 SUPPL-8 Labeling

Label is not available on this site.

06/25/2007 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/2006 SUPPL-4 Labeling

Label is not available on this site.

CIPROFLOXACIN HYDROCHLORIDE

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription Yes AB 019537 BAYER HLTHCARE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 077859 AUROBINDO PHARMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076126 CARLSBAD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076896 CHARTWELL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 075593 DR REDDYS LABS LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076558 HIKMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076089 IVAX SUB TEVA PHARMS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 075817 MYLAN
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076912 TARO
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076639 UNIQUE PHARM LABS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076794 WATSON LABS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 208921 YILING PHARM LTD

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