Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090722
Company: TORRENT PHARMS

Products on ANDA 090722

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET;ORAL	Discontinued	None	No	No
LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET;ORAL	Discontinued	None	No	No
LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090722

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
06/21/2023	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/03/2019	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/17/2019	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/17/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/17/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/17/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/08/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/08/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/25/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/23/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/02/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.