Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076361
Company: TEVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription AB No No
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription AB No No
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription AB 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
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
05/03/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/26/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
09/19/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
09/19/2014 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/22/2012 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/24/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
02/10/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
10/20/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
07/15/2014 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

LEVOFLOXACIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 090787 APOTEX INC
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 201043 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 090367 CELLTRION
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 076890 CIPLA LTD
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 076710 DR REDDYS LABS INC
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 200250 GLENMARK GENERICS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 204968 HEC PHARM
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 202801 HETERO LABS LTD V
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 203613 JUBILANT GENERICS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 078424 LUPIN
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 200839 MACLEODS PHARMS LTD
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 202200 ORCHID HLTHCARE
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 077438 SANDOZ
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 076361 TEVA
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 077652 ZYDUS PHARMS USA INC

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 090787 APOTEX INC
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 201043 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 090367 CELLTRION
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 076890 CIPLA LTD
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 076710 DR REDDYS LABS INC
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 200250 GLENMARK GENERICS
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 204968 HEC PHARM
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 202801 HETERO LABS LTD V
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 203613 JUBILANT GENERICS
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 078424 LUPIN
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 200839 MACLEODS PHARMS LTD
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 202200 ORCHID HLTHCARE
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 077438 SANDOZ
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 076361 TEVA
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 077652 ZYDUS PHARMS USA INC

TABLET;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 090787 APOTEX INC
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 201043 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 090367 CELLTRION
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 076890 CIPLA LTD
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 076710 DR REDDYS LABS INC
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 200250 GLENMARK GENERICS
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 204968 HEC PHARM
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 202801 HETERO LABS LTD V
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 078424 LUPIN
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 200839 MACLEODS PHARMS LTD
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 202200 ORCHID HLTHCARE
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 077438 SANDOZ
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 076361 TEVA
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 077652 ZYDUS PHARMS USA INC

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