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检索条件:" 药品名称=INDOCIN"
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
INDOCIN 016059 001 NDA INDOMETHACIN CAPSULE;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1965/06/10 Approved Prior to Jan 1, 1982 ZYLA LIFE SCIENCES Discontinued
INDOCIN 016059 002 NDA INDOMETHACIN CAPSULE;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1965/06/10 Approved Prior to Jan 1, 1982 ZYLA LIFE SCIENCES Discontinued
INDOCIN SR 018185 001 NDA INDOMETHACIN CAPSULE, EXTENDED RELEASE;ORAL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/02/23 1982/02/23 ZYLA Discontinued
INDOCIN 017814 001 NDA INDOMETHACIN SUPPOSITORY;RECTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/08/13 1984/08/13 ZYLA LIFE SCIENCES Discontinued
INDOCIN 018878 001 NDA INDOMETHACIN SODIUM INJECTABLE;INJECTION EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1985/01/30 1985/01/30 RECORDATI RARE Discontinued
INDOCIN 018332 001 NDA INDOMETHACIN SUSPENSION;ORAL 25MG/5ML Yes Yes 1985/10/10 1985/10/10 ZYLA Prescription
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