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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076182
Company: TEVA

Products on ANDA 076182

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OFLOXACIN	OFLOXACIN	200MG	TABLET;ORAL	Prescription	AB	No	No
OFLOXACIN	OFLOXACIN	300MG	TABLET;ORAL	Prescription	AB	No	No
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076182

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/2003	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
05/03/2019	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/30/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/26/2016	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/10/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf
08/14/2013	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/14/2013	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf
08/13/2013	SUPPL-11	Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide		Label is not available on this site.
03/10/2011	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/13/2013	SUPPL-9	REMS-Modified		Label is not available on this site.
04/21/2010	SUPPL-8	REMS-Proposal, Labeling		Label is not available on this site.
12/19/2008	SUPPL-7	Labeling		Label is not available on this site.
04/25/2008	SUPPL-6	Labeling		Label is not available on this site.
02/06/2008	SUPPL-5	Labeling		Label is not available on this site.
03/16/2007	SUPPL-4	Labeling		Label is not available on this site.
10/17/2006	SUPPL-3	Labeling		Label is not available on this site.
08/30/2005	SUPPL-2	Labeling		Label is not available on this site.
04/08/2005	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 076182

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf
08/14/2013	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf
08/14/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf

Therapeutic Equivalents for ANDA 076182

OFLOXACIN

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OFLOXACIN	OFLOXACIN	200MG	TABLET;ORAL	Prescription	No	AB	091656	CADILA PHARMS LTD
OFLOXACIN	OFLOXACIN	200MG	TABLET;ORAL	Prescription	No	AB	077098	DR REDDYS LABS LTD
OFLOXACIN	OFLOXACIN	200MG	TABLET;ORAL	Prescription	No	AB	076182	TEVA

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OFLOXACIN	OFLOXACIN	300MG	TABLET;ORAL	Prescription	No	AB	091656	CADILA PHARMS LTD
OFLOXACIN	OFLOXACIN	300MG	TABLET;ORAL	Prescription	No	AB	077098	DR REDDYS LABS LTD
OFLOXACIN	OFLOXACIN	300MG	TABLET;ORAL	Prescription	No	AB	076182	TEVA

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	091656	CADILA PHARMS LTD
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	077098	DR REDDYS LABS LTD
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	076093	LARKEN LABS
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	076182	TEVA

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