Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090787
Company: APOTEX INC

Products on ANDA 090787

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	AB	No	No
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	AB	No	No
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090787

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2011	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
02/11/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/02/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/02/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/06/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/24/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/24/2019	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/24/2019	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/24/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/31/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
07/22/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090787

LEVOFLOXACIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	090787	APOTEX INC
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	201043	AUROBINDO PHARMA LTD
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	076890	CHARTWELL MOLECULAR
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	076710	DR REDDYS LABS INC
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	200250	GLENMARK PHARMS LTD
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	204968	HEC PHARM
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	202801	HETERO LABS LTD V
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	078424	LUPIN
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	200839	MACLEODS PHARMS LTD
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	202200	ORBION PHARMS
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	077438	SANDOZ
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	076361	TEVA
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Prescription	No	AB	077652	ZYDUS LIFESCIENCES

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	090787	APOTEX INC
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	201043	AUROBINDO PHARMA LTD
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	076890	CHARTWELL MOLECULAR
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	076710	DR REDDYS LABS INC
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	200250	GLENMARK PHARMS LTD
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	204968	HEC PHARM
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	202801	HETERO LABS LTD V
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	078424	LUPIN
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	200839	MACLEODS PHARMS LTD
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	202200	ORBION PHARMS
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	077438	SANDOZ
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	076361	TEVA
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Prescription	No	AB	077652	ZYDUS LIFESCIENCES

TABLET;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	090787	APOTEX INC
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	201043	AUROBINDO PHARMA LTD
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	076890	CHARTWELL MOLECULAR
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	076710	DR REDDYS LABS INC
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	200250	GLENMARK PHARMS LTD
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	204968	HEC PHARM
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	202801	HETERO LABS LTD V
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	078424	LUPIN
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	200839	MACLEODS PHARMS LTD
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	202200	ORBION PHARMS
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	077438	SANDOZ
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	076361	TEVA
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Prescription	No	AB	077652	ZYDUS LIFESCIENCES