An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077859
Company: AUROBINDO PHARMA

Products on ANDA 077859

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 077859

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2007	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
02/09/2024	SUPPL-44	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/24/2013	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/01/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/28/2012	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/27/2012	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/08/2011	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/08/2011	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/24/2009	SUPPL-7	Labeling, REMS-Proposal		Label is not available on this site.
02/23/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/20/2009	SUPPL-5	Labeling		Label is not available on this site.
12/02/2008	SUPPL-4	Labeling		Label is not available on this site.
05/13/2008	SUPPL-3	Labeling		Label is not available on this site.
10/05/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077859

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

Top