Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090787
Company: APOTEX INC

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
09/29/2011 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
09/24/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
09/24/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
07/31/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
07/22/2013 SUPPL-1 Labeling-Package Insert

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 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 090722 TORRENT PHARMS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 090367 WOCKHARDT
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 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 090722 TORRENT PHARMS
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 090367 WOCKHARDT
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 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 090722 TORRENT PHARMS
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 090367 WOCKHARDT
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 077652 ZYDUS PHARMS USA INC

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