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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076639
Company: UNIQUE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
09/10/2004 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
12/17/2025 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-29 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
12/19/2022 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
12/19/2022 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/19/2022 SUPPL-18 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.
12/19/2022 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/19/2022 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/29/2015 SUPPL-12 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
09/29/2015 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/22/2013 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
07/25/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
03/29/2012 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/28/2011 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/16/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
03/09/2010 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

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 076593 AIPING PHARM INC
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 076593 AIPING PHARM INC
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 076593 AIPING PHARM INC
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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