Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203189
Company: HI-TECH PHARMA CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC 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
09/03/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203189Orig1s000ltr.pdf

GATIFLOXACIN

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203189 HI-TECH PHARMA CO
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202653 LUPIN LTD
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206446 MYLAN
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204227 SANDOZ INC
ZYMAXID GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 022548 ALLERGAN

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