Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076109
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 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
11/05/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076109s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/05/2018 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

12/11/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/28/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

KETOROLAC TROMETHAMINE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACULAR KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019700 ALLERGAN
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078434 AKORN
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076109 APOTEX INC
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203410 MICRO LABS LTD INDIA
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076583 SANDOZ INC
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090017 SUN PHARM

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