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 | 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TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1999/04/26 | 1999/04/26 | HIKMA | Discontinued |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 |
ETHAMBUTOL HYDROCHLORIDE | 075095 | 001 | ANDA | ETHAMBUTOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 1999/11/30 | 1999/11/30 | EPIC PHARMA LLC | Prescription |
ETHAMBUTOL HYDROCHLORIDE | 075095 | 002 | ANDA | ETHAMBUTOL HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 1999/11/30 | 1999/11/30 | EPIC PHARMA LLC | Prescription |
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 |
KETOROLAC TROMETHAMINE | 075631 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 2001/06/29 | 2001/06/29 | BAXTER HLTHCARE CORP | Discontinued |
KETOROLAC TROMETHAMINE | 075631 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 2001/06/29 | 2001/06/29 | BAXTER HLTHCARE CORP | Discontinued |
KETOROLAC TROMETHAMINE | 075626 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 2001/07/24 | 2001/07/24 | APOTEX INC | Discontinued |
ETHAMBUTOL HYDROCHLORIDE | 076057 | 001 | ANDA | ETHAMBUTOL HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2001/11/26 | 2001/11/26 | BARR | Discontinued |
KETOROLAC TROMETHAMINE | 075784 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 2002/01/11 | 2002/01/11 | FRESENIUS KABI USA | Prescription |
KETOROLAC TROMETHAMINE | 075784 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 2002/01/11 | 2002/01/11 | FRESENIUS KABI USA | Prescription |
METHAMPHETAMINE HYDROCHLORIDE | 040529 | 001 | ANDA | METHAMPHETAMINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No | 2004/02/25 | 2004/02/25 | ABLE | Discontinued |
KETOROLAC TROMETHAMINE | 075772 | 001 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No | 2004/07/21 | 2004/07/21 | HIKMA | Prescription |
KETOROLAC TROMETHAMINE | 075772 | 002 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No | 2004/07/21 | 2004/07/21 | HIKMA | Prescription |
KETOROLAC TROMETHAMINE | 075772 | 003 | ANDA | KETOROLAC TROMETHAMINE | INJECTABLE; INJECTION | 60MG/2ML | No | No | 2004/07/21 | -- | HIKMA | Prescription |