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Abbreviated New Drug Application (ANDA): 076231
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Discontinued None 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
05/14/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76231ltr.pdf
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