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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) 050617 | 001 | ERYGEL | ERYTHROMYCIN | 红霉素 | GEL;TOPICAL | 2% | MYLAN | 1987-10-21 | Yes | Yes | RX | AT |
(NDA) 050611 | 001 | PCE | ERYTHROMYCIN | 红霉素 | TABLET, COATED PARTICLES;ORAL | 333MG | AZURITY | 1986-09-09 | Yes | No | DISCN | |
(NDA) 050611 | 002 | PCE | ERYTHROMYCIN | 红霉素 | TABLET, COATED PARTICLES;ORAL | 500MG | AZURITY | 1990-08-22 | Yes | No | DISCN | |
(NDA) 050594 | 001 | ERYCETTE | ERYTHROMYCIN | 红霉素 | SWAB;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | JOHNSON AND JOHNSON | 1985-02-15 | Yes | No | DISCN | |
(NDA) 050584 | 001 | AKNE-MYCIN | ERYTHROMYCIN | 红霉素 | OINTMENT;TOPICAL | 2% | BAUSCH | 1985-01-10 | Yes | No | DISCN | |
(NDA) 050536 | 001 | ERYC | ERYTHROMYCIN | 红霉素 | CAPSULE, DELAYED REL PELLETS;ORAL | 250MG | DR REDDYS LABS SA | 1982-01-01 | Yes | Yes | RX | AB |
(NDA) 050526 | 001 | STATICIN | ERYTHROMYCIN | 红霉素 | SOLUTION;TOPICAL | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WESTWOOD SQUIBB | 1982-01-01 | Yes | No | DISCN |