Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077438
Company: SANDOZ

Products on ANDA 077438

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 077438

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2011	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
06/28/2023	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/06/2020	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/03/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/22/2012	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/10/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/03/2012	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2014	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/04/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077438

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