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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
TERBUTALINE SULFATE | 075877 | 001 | ANDA | TERBUTALINE SULFATE | TABLET;ORAL | 2.5MG | No | No | 2001/06/26 | 2001/06/26 | IMPAX LABS | Prescription |
TERBUTALINE SULFATE | 075877 | 002 | ANDA | TERBUTALINE SULFATE | TABLET;ORAL | 5MG | No | No | 2001/06/26 | 2001/06/26 | IMPAX LABS | Prescription |
TERBUTALINE SULFATE | 076770 | 001 | ANDA | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | No | Yes | 2004/04/23 | 2004/04/23 | CHARTWELL INJECTABLE | Prescription |
TERBUTALINE SULFATE | 076887 | 001 | ANDA | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2004/05/26 | 2004/05/26 | FRESENIUS KABI USA | Prescription |
TERBUTALINE SULFATE | 076853 | 001 | ANDA | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2004/07/20 | 2004/07/20 | DR REDDYS | Discontinued |
TERBUTALINE SULFATE | 077152 | 001 | ANDA | TERBUTALINE SULFATE | TABLET;ORAL | 2.5MG | No | No | 2005/03/25 | 2005/03/25 | LANNETT CO INC | Prescription |
TERBUTALINE SULFATE | 077152 | 002 | ANDA | TERBUTALINE SULFATE | TABLET;ORAL | 5MG | No | Yes | 2005/03/25 | 2005/03/25 | LANNETT CO INC | Prescription |
TERBUTALINE SULFATE | 078151 | 001 | ANDA | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2008/01/07 | 2008/01/07 | EPIC PHARMA LLC | Discontinued |
TERBUTALINE SULFATE | 078630 | 001 | ANDA | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2009/05/20 | 2009/05/20 | HIKMA FARMACEUTICA | Prescription |
TERBUTALINE SULFATE | 200122 | 001 | ANDA | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2013/11/08 | 2013/11/08 | AREVA PHARMS | Prescription |
TERBUTALINE SULFATE | 211832 | 001 | ANDA | TERBUTALINE SULFATE | TABLET;ORAL | 2.5MG | No | No | 2020/06/19 | 2020/06/19 | TWI PHARMS | Prescription |
TERBUTALINE SULFATE | 211832 | 002 | ANDA | TERBUTALINE SULFATE | TABLET;ORAL | 5MG | No | No | 2020/06/19 | 2020/06/19 | TWI PHARMS | Prescription |