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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076558
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN CIPROFLOXACIN 250MG TABLET; ORAL Prescription None No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription AB No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription AB No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription AB 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/2004/76558ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2023 SUPPL-63 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/31/2023 SUPPL-59 Labeling-Package Insert

Label is not available on this site.
08/31/2023 SUPPL-56 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/31/2023 SUPPL-55 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/31/2023 SUPPL-53 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/31/2023 SUPPL-51 Labeling-Package Insert

Label is not available on this site.
08/31/2023 SUPPL-49 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/07/2018 SUPPL-46 Labeling-Package Insert

Label is not available on this site.
11/07/2018 SUPPL-41 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/21/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
09/21/2015 SUPPL-36 Labeling-Package Insert

Label is not available on this site.
09/21/2015 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
08/15/2012 SUPPL-34 Labeling-Package Insert, REMS-Modified

Label is not available on this site.
07/11/2012 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
02/28/2012 SUPPL-31 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
05/08/2011 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
05/12/2011 SUPPL-27 Labeling-Package Insert

Label is not available on this site.
10/31/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
08/24/2009 SUPPL-21 Labeling

Label is not available on this site.
08/20/2009 SUPPL-19 Labeling

Label is not available on this site.
01/29/2009 SUPPL-17 Labeling

Label is not available on this site.
03/16/2008 SUPPL-14 Labeling

Label is not available on this site.
02/06/2008 SUPPL-13 Labeling

Label is not available on this site.
02/09/2007 SUPPL-12 Labeling

Label is not available on this site.
11/29/2005 SUPPL-8 Labeling

Label is not available on this site.
06/29/2005 SUPPL-7 Labeling

Label is not available on this site.
02/04/2009 SUPPL-4 Labeling

Label is not available on this site.

CIPROFLOXACIN

There are no Therapeutic Equivalents.

CIPROFLOXACIN HYDROCHLORIDE

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription Yes AB 019537 BAYER HLTHCARE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 075939 AMNEAL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077859 AUROBINDO PHARMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076126 CARLSBAD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076896 CHARTWELL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 075593 DR REDDYS LABS LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076558 HIKMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076089 IVAX SUB TEVA PHARMS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076639 UNIQUE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076794 WATSON LABS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 208921 YILING

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 075939 AMNEAL
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 RISING
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076639 UNIQUE
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

TABLET;ORAL; EQ 750MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 075939 AMNEAL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 077859 AUROBINDO PHARMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076126 CARLSBAD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076896 CHARTWELL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 075593 DR REDDYS LABS LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076558 HIKMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076089 IVAX SUB TEVA PHARMS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076639 UNIQUE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076794 WATSON LABS
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