Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091436
Company: BAXTER HLTHCARE CORP

Products on ANDA 091436

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091436

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2013	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
05/06/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/06/2019	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/23/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/23/2014	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.