Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204227
Company: SANDOZ INC

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
07/11/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204227Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2019 SUPPL-1 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
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 213542 TORRENT
ZYMAXID GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 022548 ALLERGAN

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