Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203410
Company: MICRO LABS LTD INDIA
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 | ABBVIE |
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 | 218204 | CAPLIN |
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 |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090017 | SUN PHARM |