Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076109
Company: APOTEX INC
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 | 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 |