美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=METHYLIN"
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
METHYLIN ER 075629 001 ANDA METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG No No 2000/05/09 2000/05/09 SPECGX LLC Prescription
METHYLIN ER 075629 002 ANDA METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MG No No 2000/05/09 2000/05/09 SPECGX LLC Prescription
METHYLIN 021419 001 NDA METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Yes Yes 2002/12/19 2002/12/19 SPECGX LLC Prescription
METHYLIN 021419 002 NDA METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Yes Yes 2002/12/19 2002/12/19 SPECGX LLC Prescription
METHYLIN 021475 001 NDA METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/04/15 2003/04/15 SPECGX LLC Discontinued
METHYLIN 021475 002 NDA METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/04/15 2003/04/15 SPECGX LLC Discontinued
METHYLIN 021475 003 NDA METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/04/15 2003/04/15 SPECGX LLC Discontinued
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