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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076794
Company: WATSON LABS

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 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/2004/76794ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2022 SUPPL-46 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-44 Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-42 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/19/2022 SUPPL-40 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/19/2022 SUPPL-39 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/19/2022 SUPPL-38 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/19/2022 SUPPL-36 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
11/10/2015 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/10/2015 SUPPL-31 Labeling-Package Insert

Label is not available on this site.
04/25/2013 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
03/13/2012 SUPPL-26 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
05/16/2011 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/24/2009 SUPPL-16 Labeling

Label is not available on this site.
12/19/2008 SUPPL-13 Labeling

Label is not available on this site.
05/13/2008 SUPPL-9 Labeling

Label is not available on this site.
02/21/2007 SUPPL-6 Labeling

Label is not available on this site.
10/22/2006 SUPPL-5 Labeling

Label is not available on this site.
08/30/2005 SUPPL-3 Labeling

Label is not available on this site.
02/10/2005 SUPPL-2

Label is not available on this site.
02/10/2005 SUPPL-1 Labeling

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 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 076593 AIPING PHARM INC
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 076593 AIPING PHARM INC
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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