Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076616
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription AT 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
03/17/2008 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
08/13/2013 SUPPL-3 Labeling-Patient Package Insert

Label is not available on this site.

05/10/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

OFLOXACIN

SOLUTION/DROPS;OTIC; 0.3%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 090395 ALVOGEN
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 211525 AMNEAL PHARMS CO
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 076527 APOTEX INC
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 076128 BAUSCH AND LOMB
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 076616 HI TECH PHARMA

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