Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077308
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 0.4% | 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/2009/077308s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/27/2017 | SUPPL-7 | Labeling-Package Insert |
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; 0.4%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACULAR LS | KETOROLAC TROMETHAMINE | 0.4% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 021528 | ABBVIE |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 0.4% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 077308 | APOTEX INC |