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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
VASCORAY | 016783 | 001 | NDA | IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM | INJECTABLE;INJECTION | 52%;26% | No | No | 1971/01/26 | Approved Prior to Jan 1, 1982 | MALLINCKRODT | Discontinued |
VASCOR | 019002 | 001 | NDA | BEPRIDIL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 1990/12/28 | 1990/12/28 | JOHNSON AND JOHNSON | Discontinued |
VASCOR | 019002 | 002 | NDA | BEPRIDIL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 1990/12/28 | 1990/12/28 | JOHNSON AND JOHNSON | Discontinued |
VASCOR | 019002 | 003 | NDA | BEPRIDIL HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 1990/12/28 | 1990/12/28 | JOHNSON AND JOHNSON | Discontinued |
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID | 090145 | 001 | ANDA | ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE | FOR SOLUTION;ORAL | 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM | No | No | 2012/01/25 | 2012/01/25 | NOVEL LABS INC | Prescription |
ASCOR | 209112 | 001 | NDA | ASCORBIC ACID | SOLUTION;INTRAVENOUS | 25,000MG/50ML (500MG/ML) | Yes | Yes | 2017/10/02 | 2017/10/02 | MCGUFF | Prescription |