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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211525
Company: AMNEAL
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
08/30/2019 ORIG-1 Approval STANDARD

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 076616 AKORN
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 211525 AMNEAL
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 216130 MANKIND PHARMA
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