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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202653
Company: LUPIN LTD
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
08/28/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202653Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/02/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

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 AKORN
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202653 LUPIN LTD
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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