Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077097
Company: NATCO PHARMA

Products on ANDA 077097

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077097

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
09/20/2024	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/10/2024	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/03/2019	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/26/2019	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/26/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/19/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/28/2012	SUPPL-2	Labeling-Package Insert, REMS		Label is not available on this site.
10/21/2011	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.