KETOROLAC TROMETHAMINE INJECTION, USP DIN 02481138
Health Canada record
| Active ingredient(s) | KETOROLAC TROMETHAMINE 30 MG |
|---|---|
| Dosage form | Liquid |
| Route | Intramuscular |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M01AB15 KETOROLAC |
| Original market date | |
| Current status date | 03-May-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
Fresenius Kabi Canada Ltd. — licence 102232, currently licensed, last inspection rating C (2025-10-01).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing KETOROLAC TROMETHAMINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 01968300 | ACULAR | ABBVIE CORPORATION | Solution | KETOROLAC TROMETHAMINE 0.5 % | Marketed |
| 02369362 | ACUVAIL | ABBVIE CORPORATION | Solution | KETOROLAC TROMETHAMINE 0.45 % | Marketed |
| 02229080 | APO-KETOROLAC | APOTEX INC | Tablet | KETOROLAC TROMETHAMINE 10 MG | Marketed |
| 02510855 | JAMP KETOROLAC | JAMP PHARMA CORPORATION | Tablet | KETOROLAC TROMETHAMINE 10 MG | Marketed |
| 02245821 | KETOROLAC | AA PHARMA INC | Solution | KETOROLAC TROMETHAMINE 0.5 % | Marketed |
| 02461129 | KETOROLAC TROMETHAMINE INJECTION USP | STERIMAX INC | Solution | KETOROLAC TROMETHAMINE 30 MG | Approved |
| 02443376 | KETOROLAC TROMETHAMINE INJECTION, USP | JUNO PHARMA CANADA INC. | Solution | KETOROLAC TROMETHAMINE 30 MG | Marketed |
| 02533022 | KETOROLAC TROMETHAMINE INJECTION, USP | EUGIA PHARMA INC. | Solution | KETOROLAC TROMETHAMINE 30 MG | Approved |
| 02244947 | KETOROLAC TROMETHAMINE INJECTION, USP | FRESENIUS KABI CANADA LTD | Liquid | KETOROLAC TROMETHAMINE 30 MG | Marketed |
| 02521601 | KETOROLAC TROMETHAMINE INJECTION, USP | AURO PHARMA INC | Solution | KETOROLAC TROMETHAMINE 30 MG | Approved |
| 02465124 | MAR-KETOROLAC | MARCAN PHARMACEUTICALS INC | Tablet | KETOROLAC TROMETHAMINE 10 MG | Marketed |
| 02461455 | MINT-KETOROLAC | MINT PHARMACEUTICALS INC | Tablet | KETOROLAC TROMETHAMINE 10 MG | Marketed |
| 02162660 | TORADOL | AA PHARMA INC | Tablet | KETOROLAC TROMETHAMINE 10 MG | Marketed |
| 02162644 | TORADOL IM | ATNAHS PHARMA UK LIMITED | Solution | KETOROLAC TROMETHAMINE 10 MG | Marketed |
| 02462567 | WAYMADE-KETOROLAC TROMETHAMINE | WAYMADE PLC | Tablet | KETOROLAC TROMETHAMINE 10 MG | Approved |
| 02248722 | ACULAR LS | ABBVIE CORPORATION | Solution | KETOROLAC TROMETHAMINE 0.4 % | Cancelled Post Market |
| 02243989 | APO-KETOROLAC INJECTABLE | APOTEX INC | Solution | KETOROLAC TROMETHAMINE 30 MG | Dormant |
| 02523310 | KETOROLAC TROMETHAMINE INJECTION USP | JAMP PHARMA CORPORATION | Solution | KETOROLAC TROMETHAMINE 30 MG | Dormant |
| 02239943 | KETOROLAC TROMETHAMINE INJECTION USP | SABEX INC | Liquid | KETOROLAC TROMETHAMINE 10 MG | Cancelled Pre Market |
| 02239944 | KETOROLAC TROMETHAMINE INJECTION USP | SANDOZ CANADA INCORPORATED | Solution | KETOROLAC TROMETHAMINE 30 MG | Cancelled Post Market |
| 02390582 | KETOROLAC TROMETHAMINE INJECTION USP | PFIZER CANADA ULC | Solution | KETOROLAC TROMETHAMINE 30 MG | Cancelled Post Market |
| 02539357 | KETOROLAC TROMETHAMINE INJECTION, USP | OMEGA LABORATORIES LIMITED | Solution | KETOROLAC TROMETHAMINE 30 MG | Cancelled Pre Market |
| 02230201 | NOVO-KETOROLAC - TAB 10MG | NOVOPHARM LIMITED | Tablet | KETOROLAC TROMETHAMINE 10 MG | Cancelled Post Market |
| 02237910 | NU-KETOROLAC | NU-PHARM INC | Tablet | KETOROLAC TROMETHAMINE 10 MG | Cancelled Post Market |
| 02336693 | NU-KETOROLAC OPHTHALMIC SOLUTION | NU-PHARM INC | Solution | KETOROLAC TROMETHAMINE 0.5 % | Cancelled (Unreturned Annual) |
| 02247461 | RATIO-KETOROLAC | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Solution | KETOROLAC TROMETHAMINE 0.5 % | Cancelled Post Market |
| 02242189 | RIVA-KETOROLAC 10 MG | LABORATOIRE RIVA INC. | Tablet | KETOROLAC TROMETHAMINE 10 MG | Cancelled Pre Market |
| 02162652 | TORADOL IM 30MG/ML | HOFFMANN-LA ROCHE LIMITED | Liquid | KETOROLAC TROMETHAMINE 30 MG | Cancelled Post Market |
| 00882909 | TORADOL INJ 10MG/ML | SYNTEX INC. | Liquid | KETOROLAC TROMETHAMINE 10 MG | Cancelled Post Market |
| 00864048 | TORADOL TAB 10MG | SYNTEX INC. | Tablet | KETOROLAC TROMETHAMINE 10 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 21345 | 2018-09-25 | Supplement to an Abbreviated New Drug Submission (SANDS) | New formulation, Change in drug product shelf-life, New primary container closure system, Additional drug product manufacturing site, Revisions to the Product Monograph and product labels |
International API supply for KETOROLAC TROMETHAMINE
11 active FDA Drug Master Files.
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