美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=TYLENOL W/ CODEINE"
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
TYLENOL W/ CODEINE 085057 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION;ORAL 120MG/5ML;12MG/5ML No No -- Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM Discontinued
TYLENOL W/ CODEINE 085056 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1976/07/09 Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM Discontinued
TYLENOL W/ CODEINE 085056 002 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1976/07/09 Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM Discontinued
TYLENOL W/ CODEINE 085056 003 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1976/07/09 Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM Discontinued
TYLENOL W/ CODEINE 085056 004 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1976/07/09 Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM Discontinued
TYLENOL W/ CODEINE NO. 1 085055 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;7.5MG No No 1977/08/17 Approved Prior to Jan 1, 1982 JANSSEN PHARMS Discontinued
TYLENOL W/ CODEINE NO. 2 085055 002 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG No No 1977/08/17 Approved Prior to Jan 1, 1982 JANSSEN PHARMS Discontinued
TYLENOL W/ CODEINE NO. 3 085055 003 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG No Yes 1977/08/17 Approved Prior to Jan 1, 1982 JANSSEN PHARMS Prescription
TYLENOL W/ CODEINE NO. 4 085055 004 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG No No 1977/08/17 Approved Prior to Jan 1, 1982 JANSSEN PHARMS Prescription
TYLENOL W/ CODEINE NO. 4 087421 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE;ORAL 300MG;60MG No No 1981/09/29 Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM Discontinued
TYLENOL W/ CODEINE NO. 3 087422 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE;ORAL 300MG;30MG No No 1981/09/29 Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM Discontinued
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