Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091678
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN LEVOFLOXACIN 250MG/10ML SOLUTION;ORAL Prescription AA No Yes
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 Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/23/2019 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/18/2018 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/22/2019 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/11/2015 SUPPL-3 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/08/2013 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/05/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVOFLOXACIN

SOLUTION;ORAL; 250MG/10ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN LEVOFLOXACIN 250MG/10ML SOLUTION;ORAL Prescription No AA 091678 HI TECH PHARMA
LEVOFLOXACIN LEVOFLOXACIN 250MG/10ML SOLUTION;ORAL Prescription No AA 205222 LANNETT CO INC

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