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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) 021131 | 003 | ZYVOX | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | PFIZER | 2000-04-18 | Yes | Yes | RX | AP |
(NDA) 021131 | 001 | ZYVOX | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | PFIZER | 2000-04-18 | Yes | No | RX | AP |
(NDA) 021130 | 001 | ZYVOX | LINEZOLID | 利奈唑胺 | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PFIZER | 2000-04-18 | Yes | No | DISCN | |
(NDA) 021132 | 001 | ZYVOX | LINEZOLID | 利奈唑胺 | FOR SUSPENSION;ORAL | 100MG/5ML | PFIZER | 2000-04-18 | Yes | Yes | RX | AB |
(NDA) 021130 | 002 | ZYVOX | LINEZOLID | 利奈唑胺 | TABLET;ORAL | 600MG | PFIZER | 2000-04-18 | Yes | Yes | RX | AB |
(NDA) 021131 | 002 | ZYVOX | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PFIZER | 2000-04-18 | Yes | No | DISCN | |
(NDA) 202379 | 001 | ZYTIGA | ABIRATERONE ACETATE | 醋酸阿比特龙 | TABLET;ORAL | 250MG | JANSSEN BIOTECH | 2011-04-28 | Yes | No | RX | AB |
(NDA) 202379 | 002 | ZYTIGA | ABIRATERONE ACETATE | 醋酸阿比特龙 | TABLET;ORAL | 500MG | JANSSEN BIOTECH | 2017-04-14 | Yes | Yes | RX | AB |
(NDA) 021150 | 002 | ZYRTEC-D 12 HOUR | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 盐酸西替利嗪;盐酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | KENVUE BRANDS | 2007-11-09 | Yes | Yes | OTC | |
(NDA) 019835 | 005 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 盐酸西替利嗪 | TABLET;ORAL | 5MG | KENVUE BRANDS | 2007-11-16 | Yes | No | DISCN | |
(NDA) 019835 | 006 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 盐酸西替利嗪 | TABLET;ORAL | 10MG | KENVUE BRANDS | 2007-11-16 | Yes | No | DISCN | |
(NDA) 019835 | 004 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 盐酸西替利嗪 | TABLET;ORAL | 10MG | KENVUE BRANDS | 2007-11-16 | Yes | Yes | OTC | |
(NDA) 019835 | 003 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 盐酸西替利嗪 | TABLET;ORAL | 5MG | KENVUE BRANDS | 2007-11-16 | Yes | No | DISCN | |
(NDA) 022578 | 001 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 盐酸西替利嗪 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | KENVUE BRANDS | 2010-09-03 | Yes | Yes | OTC | |
(NDA) 020346 | 001 | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 盐酸西替利嗪 | SOLUTION;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | J AND J CONSUMER INC | 1996-09-27 | Yes | No | DISCN | |
(NDA) 021086 | 002 | ZYPREXA ZYDIS | OLANZAPINE | 奥氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | CHEPLAPHARM | 2000-04-06 | Yes | No | RX | AB |
(NDA) 021086 | 001 | ZYPREXA ZYDIS | OLANZAPINE | 奥氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | CHEPLAPHARM | 2000-04-06 | Yes | Yes | RX | AB |
(NDA) 021086 | 003 | ZYPREXA ZYDIS | OLANZAPINE | 奥氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | CHEPLAPHARM | 2000-04-06 | Yes | No | RX | AB |
(NDA) 021086 | 004 | ZYPREXA ZYDIS | OLANZAPINE | 奥氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 20MG | CHEPLAPHARM | 2000-04-06 | Yes | No | RX | AB |
(NDA) 022173 | 001 | ZYPREXA RELPREVV | OLANZAPINE PAMOATE | 双羟萘酸奥氮平 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | EQ 210MG BASE/VIAL | CHEPLAPHARM | 2009-12-11 | Yes | No | RX |