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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 205410 | 001 | HEMANGEOLP | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | SOLUTION;ORAL | 4.28MG/ML | PIERRE FABRE | 2014-03-14 | Yes | Yes | RX | |
(NDA) 021438 | 001 | INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | ANI PHARMS | 2003-03-12 | Yes | No | RX | BX |
(NDA) 021438 | 002 | INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | ANI PHARMS | 2003-03-12 | Yes | Yes | RX | BX |
(NDA) 018553 | 001 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 160MG | ANI PHARMS | 1983-04-19 | Yes | Yes | RX | AB |
(NDA) 018553 | 002 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | ANI PHARMS | 1983-04-19 | Yes | No | RX | AB |
(NDA) 018553 | 003 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | ANI PHARMS | 1983-04-19 | Yes | No | RX | AB |
(NDA) 018553 | 004 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | ANI PHARMS | 1987-03-18 | Yes | No | RX | AB |
(NDA) 016419 | 001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAXTER HLTHCARE CORP | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016418 | 001 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016418 | 002 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016418 | 003 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016418 | 004 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016418 | 009 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS | 1982-10-18 | Yes | No | DISCN | |
(NDA) 016418 | 010 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | TABLET;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS | 1982-10-18 | Yes | No | DISCN |