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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076896
Company: CHARTWELL

Products on ANDA 076896

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076896

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2004	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
10/06/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/25/2013	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/01/2012	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
01/11/2012	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/25/2010	SUPPL-11	REMS-Proposal		Label is not available on this site.
07/16/2009	SUPPL-10	Labeling		Label is not available on this site.
03/20/2009	SUPPL-9	Labeling		Label is not available on this site.
09/16/2008	SUPPL-8	Labeling		Label is not available on this site.
07/09/2007	SUPPL-6	Labeling		Label is not available on this site.
07/09/2007	SUPPL-5	Labeling		Label is not available on this site.
07/09/2007	SUPPL-4	Labeling		Label is not available on this site.
07/23/2007	SUPPL-3	Labeling		Label is not available on this site.
06/29/2005	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076896

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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