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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) 017814 | 001 | INDOCIN | INDOMETHACIN | 吲哚美辛 | SUPPOSITORY;RECTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA LIFE SCIENCES | 1984-08-13 | Yes | No | DISCN | |
(NDA) 016059 | 002 | INDOCIN | INDOMETHACIN | 吲哚美辛 | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA LIFE SCIENCES | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016059 | 001 | INDOCIN | INDOMETHACIN | 吲哚美辛 | CAPSULE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA LIFE SCIENCES | 1982-01-01 | Yes | No | DISCN | |
(NDA) 204592 | 002 | ZORVOLEXP | DICLOFENAC | 双氯芬酸 | CAPSULE;ORAL | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA | 2013-10-18 | Yes | No | DISCN | |
(NDA) 202080 | 001 | OXAYDOP | OXYCODONE HYDROCHLORIDE | 盐酸羟考酮 | TABLET;ORAL | 5MG | ZYLA | 2011-06-17 | Yes | No | DISCN | |
(NDA) 204592 | 001 | ZORVOLEXP | DICLOFENAC | 双氯芬酸 | CAPSULE;ORAL | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA | 2013-10-18 | Yes | No | DISCN | |
(NDA) 018185 | 001 | INDOCIN SR | INDOMETHACIN | 吲哚美辛 | CAPSULE, EXTENDED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA | 1982-02-23 | Yes | No | DISCN | |
(NDA) 022382 | 001 | SPRIX | KETOROLAC TROMETHAMINE | 酮咯酸氨丁三醇 | SPRAY, METERED;NASAL | 15.75MG/SPRAY | ZYLA | 2010-05-14 | Yes | Yes | RX | |
(NDA) 208603 | 002 | ARYMO ERP | MORPHINE SULFATE | 硫酸吗啡 | TABLET, EXTENDED RELEASE;ORAL | 30MG | ZYLA | 2017-01-09 | Yes | No | DISCN | |
(NDA) 208603 | 001 | ARYMO ERP | MORPHINE SULFATE | 硫酸吗啡 | TABLET, EXTENDED RELEASE;ORAL | 15MG | ZYLA | 2017-01-09 | Yes | No | DISCN | |
(NDA) 018332 | 001 | INDOCIN | INDOMETHACIN | 吲哚美辛 | SUSPENSION;ORAL | 25MG/5ML | ZYLA | 1985-10-10 | Yes | Yes | RX | AB |
(NDA) 202080 | 002 | OXAYDOP | OXYCODONE HYDROCHLORIDE | 盐酸羟考酮 | TABLET;ORAL | 7.5MG | ZYLA | 2011-06-17 | Yes | No | DISCN | |
(NDA) 208603 | 003 | ARYMO ERP | MORPHINE SULFATE | 硫酸吗啡 | TABLET, EXTENDED RELEASE;ORAL | 60MG | ZYLA | 2017-01-09 | Yes | No | DISCN | |
(ANDA) 079017 | 005 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 盐酸托莫西汀 | CAPSULE;ORAL | EQ 80MG BASE | ZYDUS PHARMS USA INC | 2010-09-16 | No | No | RX | AB |
(ANDA) 078899 | 001 | BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | 甲磺酸溴隐亭 | CAPSULE;ORAL | EQ 5MG BASE | ZYDUS PHARMS USA INC | 2008-07-30 | No | No | RX | AB |
(ANDA) 091352 | 001 | OMEPRAZOLE | OMEPRAZOLE | 奥美拉唑 | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG | ZYDUS PHARMS USA INC | 2012-11-19 | No | No | RX | AB |
(ANDA) 079017 | 003 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 盐酸托莫西汀 | CAPSULE;ORAL | EQ 40MG BASE | ZYDUS PHARMS USA INC | 2010-09-16 | No | No | RX | AB |
(ANDA) 091352 | 003 | OMEPRAZOLE | OMEPRAZOLE | 奥美拉唑 | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | ZYDUS PHARMS USA INC | 2012-11-19 | No | No | RX | AB |
(ANDA) 079017 | 004 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 盐酸托莫西汀 | CAPSULE;ORAL | EQ 60MG BASE | ZYDUS PHARMS USA INC | 2010-09-16 | No | No | RX | AB |
(ANDA) 079017 | 006 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 盐酸托莫西汀 | CAPSULE;ORAL | EQ 100MG BASE | ZYDUS PHARMS USA INC | 2010-09-16 | No | No | RX | AB |