美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=ANDA212722"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
42385-925-90 42385-925 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, FILM COATED ORAL 20220719 N/A ANDA ANDA212722 Laurus Labs Limited PIRFENIDONE 534 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (42385-925-90)
70954-870-10 70954-870 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, FILM COATED ORAL 20220719 N/A ANDA ANDA212722 ANI Pharmaceuticals, Inc. PIRFENIDONE 801 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (70954-870-10)
42385-924-99 42385-924 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, FILM COATED ORAL 20220719 N/A ANDA ANDA212722 Laurus Labs Limited PIRFENIDONE 267 mg/1 3 BOTTLE in 1 CARTON (42385-924-99) / 90 TABLET, FILM COATED in 1 BOTTLE
70954-869-10 70954-869 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, FILM COATED ORAL 20220719 N/A ANDA ANDA212722 ANI Pharmaceuticals, Inc. PIRFENIDONE 267 mg/1 3 BOTTLE in 1 CARTON (70954-869-10) / 90 TABLET, FILM COATED in 1 BOTTLE
70954-869-30 70954-869 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, FILM COATED ORAL 20240228 N/A ANDA ANDA212722 ANI Pharmaceuticals, Inc. PIRFENIDONE 267 mg/1 270 TABLET, FILM COATED in 1 BOTTLE (70954-869-30)
42385-926-90 42385-926 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, FILM COATED ORAL 20220719 N/A ANDA ANDA212722 Laurus Labs Limited PIRFENIDONE 801 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (42385-926-90)
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