| NDC包装代码 | 产品NDC | 产品类型 | 商品名 | 通用名 | 剂型 | 给药途径 | 上市日期 | 结束日期 | 市场类别 | 申请号 | 标签持有者 | 活性成分 | 规格 | 包装描述 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83107-005-10 | 83107-005 | HUMAN PRESCRIPTION DRUG | BETAPACE | sotalol hydrochloride | TABLET | ORAL | 20160901 | N/A | NDA | NDA019865 | Legacy Pharma USA, Inc. | SOTALOL HYDROCHLORIDE | 80 mg/1 | 100 TABLET in 1 BOTTLE (83107-005-10) |
| 83107-009-60 | 83107-009 | HUMAN PRESCRIPTION DRUG | BETAPACE AF | sotalol hydrochloride | TABLET | ORAL | 20160901 | N/A | NDA | NDA019865 | Legacy Pharma USA, Inc. | SOTALOL HYDROCHLORIDE | 120 mg/1 | 60 TABLET in 1 BOTTLE (83107-009-60) |
| 83107-006-10 | 83107-006 | HUMAN PRESCRIPTION DRUG | BETAPACE | sotalol hydrochloride | TABLET | ORAL | 20160901 | N/A | NDA | NDA019865 | Legacy Pharma USA, Inc. | SOTALOL HYDROCHLORIDE | 120 mg/1 | 100 TABLET in 1 BOTTLE (83107-006-10) |
| 83107-010-60 | 83107-010 | HUMAN PRESCRIPTION DRUG | BETAPACE AF | sotalol hydrochloride | TABLET | ORAL | 20160901 | N/A | NDA | NDA019865 | Legacy Pharma USA, Inc. | SOTALOL HYDROCHLORIDE | 160 mg/1 | 60 TABLET in 1 BOTTLE (83107-010-60) |
| 83107-007-10 | 83107-007 | HUMAN PRESCRIPTION DRUG | BETAPACE | sotalol hydrochloride | TABLET | ORAL | 20160901 | N/A | NDA | NDA019865 | Legacy Pharma USA, Inc. | SOTALOL HYDROCHLORIDE | 160 mg/1 | 100 TABLET in 1 BOTTLE (83107-007-10) |
| 83107-008-60 | 83107-008 | HUMAN PRESCRIPTION DRUG | BETAPACE AF | sotalol hydrochloride | TABLET | ORAL | 20160901 | N/A | NDA | NDA019865 | Legacy Pharma USA, Inc. | SOTALOL HYDROCHLORIDE | 80 mg/1 | 60 TABLET in 1 BOTTLE (83107-008-60) |