| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83709-001-01 | 83709-001 | HUMAN PRESCRIPTION DRUG | XTORO | finafloxacin | SUSPENSION | AURICULAR (OTIC) | 20260501 | N/A | NDA | NDA206307 | Fonseca Biosciences, LLC | FINAFLOXACIN | 3 mg/mL | 1 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPER |
| 83709-001-90 | 83709-001 | HUMAN PRESCRIPTION DRUG | XTORO | finafloxacin | SUSPENSION | AURICULAR (OTIC) | 20260501 | N/A | NDA | NDA206307 | Fonseca Biosciences, LLC | FINAFLOXACIN | 3 mg/mL | 1 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER |
| 83709-001-91 | 83709-001 | HUMAN PRESCRIPTION DRUG | XTORO | finafloxacin | SUSPENSION | AURICULAR (OTIC) | 20260501 | N/A | NDA | NDA206307 | Fonseca Biosciences, LLC | FINAFLOXACIN | 3 mg/mL | 1 BOTTLE, DROPPER in 1 CARTON (83709-001-91) / 5 mL in 1 BOTTLE, DROPPER |