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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203410
Company: MICRO LABS LTD INDIA
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
04/05/2019 ORIG-1 Approval

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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