商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | 074754 | 001 | ANDA | KETOROLAC TROMETHAMINE | TABLET;ORAL | 10MG | No | Yes | 1997/05/16 | 1997/05/16 | TEVA | Prescription |
KETOROLAC TROMETHAMINE | 074761 | 001 | ANDA | KETOROLAC TROMETHAMINE | TABLET;ORAL | 10MG | No | No | 1997/05/16 | 1997/05/16 | MYLAN | Prescription |
KETOROLAC TROMETHAMINE | 074801 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 1997/06/05 | 1997/06/05 | HOSPIRA | Discontinued |
KETOROLAC TROMETHAMINE | 074801 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 1997/06/05 | 1997/06/05 | HOSPIRA | Discontinued |
KETOROLAC TROMETHAMINE | 074802 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | Yes | 1997/06/05 | 1997/06/05 | HOSPIRA | Prescription |
KETOROLAC TROMETHAMINE | 074802 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | Yes | 1997/06/05 | 1997/06/05 | HOSPIRA | Prescription |
KETOROLAC TROMETHAMINE | 074790 | 001 | ANDA | KETOROLAC TROMETHAMINE | TABLET;ORAL | 10MG | No | No | 1997/06/26 | 1997/06/26 | CHARTWELL RX | Discontinued |
KETOROLAC TROMETHAMINE | 074955 | 001 | ANDA | KETOROLAC TROMETHAMINE | TABLET;ORAL | 10MG | No | No | 1997/09/19 | 1997/09/19 | WATSON LABS | Discontinued |
KETOROLAC TROMETHAMINE | 074993 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 1999/01/27 | 1999/01/27 | HOSPIRA | Discontinued |
KETOROLAC TROMETHAMINE | 074993 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 1999/01/27 | 1999/01/27 | HOSPIRA | Prescription |
KETOROLAC TROMETHAMINE | 075222 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1999/04/26 | 1999/04/26 | HIKMA | Discontinued |
KETOROLAC TROMETHAMINE | 075222 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1999/04/26 | 1999/04/26 | HIKMA | Discontinued |
KETOROLAC TROMETHAMINE | 075228 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1999/04/26 | 1999/04/26 | HIKMA | Discontinued |
KETOROLAC TROMETHAMINE | 075284 | 001 | ANDA | KETOROLAC TROMETHAMINE | TABLET;ORAL | 10MG | No | No | 1999/06/23 | 1999/06/23 | PLIVA | Discontinued |
KETOROLAC TROMETHAMINE | 075230 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 1999/10/25 | 1999/10/25 | BEDFORD | Discontinued |
KETOROLAC TROMETHAMINE | 075230 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 1999/10/25 | 1999/10/25 | BEDFORD | Discontinued |
KETOROLAC TROMETHAMINE | 075299 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 1999/11/03 | 1999/11/03 | HIKMA | Discontinued |
KETOROLAC TROMETHAMINE | 075299 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 1999/11/03 | 1999/11/03 | HIKMA | Discontinued |
KETOROLAC TROMETHAMINE | 075348 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 2000/11/29 | 2000/11/28 | APOTHECON | Discontinued |
KETOROLAC TROMETHAMINE | 075348 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 2000/11/29 | 2000/11/28 | APOTHECON | Discontinued |