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=ANDA212078"
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
69097-987-05 69097-987 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 Cipla USA Inc. PIRFENIDONE 267 mg/1 90 TABLET, COATED in 1 BOTTLE (69097-987-05)
69097-987-93 69097-987 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 Cipla USA Inc. PIRFENIDONE 267 mg/1 270 TABLET, COATED in 1 BOTTLE (69097-987-93)
69097-988-05 69097-988 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 Cipla USA Inc. PIRFENIDONE 801 mg/1 90 TABLET, COATED in 1 BOTTLE (69097-988-05)
69097-988-93 69097-988 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 Cipla USA Inc. PIRFENIDONE 801 mg/1 270 TABLET, COATED in 1 BOTTLE (69097-988-93)
50228-443-05 50228-443 HUMAN PRESCRIPTION DRUG PIRFENIDONE PIRFENIDONE TABLET ORAL 20220801 N/A ANDA ANDA212078 ScieGen Pharmaceuticals, Inc. PIRFENIDONE 801 mg/1 500 TABLET in 1 BOTTLE (50228-443-05)
50228-443-30 50228-443 HUMAN PRESCRIPTION DRUG PIRFENIDONE PIRFENIDONE TABLET ORAL 20220801 N/A ANDA ANDA212078 ScieGen Pharmaceuticals, Inc. PIRFENIDONE 801 mg/1 30 TABLET in 1 BOTTLE (50228-443-30)
76282-717-27 76282-717 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 EXELAN PHARMACEUTICALS INC. PIRFENIDONE 267 mg/1 270 TABLET, COATED in 1 BOTTLE (76282-717-27)
76282-717-90 76282-717 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 EXELAN PHARMACEUTICALS INC. PIRFENIDONE 267 mg/1 90 TABLET, COATED in 1 BOTTLE (76282-717-90)
50228-442-10 50228-442 HUMAN PRESCRIPTION DRUG PIRFENIDONE PIRFENIDONE TABLET ORAL 20220801 N/A ANDA ANDA212078 ScieGen Pharmaceuticals, Inc. PIRFENIDONE 267 mg/1 1000 TABLET in 1 BOTTLE (50228-442-10)
50228-442-30 50228-442 HUMAN PRESCRIPTION DRUG PIRFENIDONE PIRFENIDONE TABLET ORAL 20220801 N/A ANDA ANDA212078 ScieGen Pharmaceuticals, Inc. PIRFENIDONE 267 mg/1 30 TABLET in 1 BOTTLE (50228-442-30)
76282-716-27 76282-716 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 EXELAN PHARMACEUTICALS INC. PIRFENIDONE 801 mg/1 270 TABLET, COATED in 1 BOTTLE (76282-716-27)
76282-716-90 76282-716 HUMAN PRESCRIPTION DRUG Pirfenidone Pirfenidone TABLET, COATED ORAL 20220802 N/A ANDA ANDA212078 EXELAN PHARMACEUTICALS INC. PIRFENIDONE 801 mg/1 90 TABLET, COATED in 1 BOTTLE (76282-716-90)
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