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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091397
Company: BAXTER HLTHCARE CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Discontinued None No No
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Discontinued None No No
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE;INJECTION Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/08/2013 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
09/20/2024 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
05/06/2019 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/06/2019 SUPPL-18 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.
10/18/2018 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
10/15/2018 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/15/2018 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/23/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
10/20/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
09/23/2014 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.
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