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=ANDA210453"
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
58602-811-57 58602-811 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20191021 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 1200 mg/1 1 BOTTLE in 1 CARTON (58602-811-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-811-60 58602-811 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20191021 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 1200 mg/1 1 BOTTLE in 1 CARTON (58602-811-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-811-64 58602-811 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20201126 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 1200 mg/1 1 BLISTER PACK in 1 CARTON (58602-811-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-811-73 58602-811 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20191021 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 1200 mg/1 1 BOTTLE in 1 CARTON (58602-811-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
71179-002-21 71179-002 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20220627 N/A ANDA ANDA210453 VESPYR BRANDS, INC. GUAIFENESIN 1200 mg/1 3 BLISTER PACK in 1 CARTON (71179-002-21) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
21130-179-67 21130-179 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20220415 N/A ANDA ANDA210453 Better Living Brands LLC GUAIFENESIN 600 mg/1 1 BLISTER PACK in 1 CARTON (21130-179-67) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-864-98 58602-864 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20210311 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 5 BLISTER PACK in 1 CARTON (58602-864-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-810-97 58602-810 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20191021 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 2 BLISTER PACK in 1 CARTON (58602-810-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-810-98 58602-810 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20191021 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 5 BLISTER PACK in 1 CARTON (58602-810-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-865-03 58602-865 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20210311 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 1200 mg/1 3 BLISTER PACK in 1 CARTON (58602-865-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
11822-4260-1 11822-4260 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20220629 N/A ANDA ANDA210453 RITE AID CORPORATION GUAIFENESIN 1200 mg/1 1 BLISTER PACK in 1 CARTON (11822-4260-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
11822-4260-2 11822-4260 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20220629 N/A ANDA ANDA210453 RITE AID CORPORATION GUAIFENESIN 1200 mg/1 2 BLISTER PACK in 1 CARTON (11822-4260-2) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
11822-4260-3 11822-4260 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20220629 N/A ANDA ANDA210453 RITE AID CORPORATION GUAIFENESIN 1200 mg/1 3 BLISTER PACK in 1 CARTON (11822-4260-3) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
68196-960-56 68196-960 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN TABLET, EXTENDED RELEASE ORAL 20250731 N/A ANDA ANDA210453 Sam's West Inc GUAIFENESIN 1200 mg/1 4 BLISTER PACK in 1 CARTON (68196-960-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-853-12 58602-853 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200813 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 1 BOTTLE in 1 CARTON (58602-853-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-853-21 58602-853 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200813 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 1 BOTTLE in 1 CARTON (58602-853-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-853-73 58602-853 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200813 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 1 BOTTLE in 1 CARTON (58602-853-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-853-96 58602-853 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200813 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 1 BLISTER PACK in 1 CARTON (58602-853-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-853-97 58602-853 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200813 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 2 BLISTER PACK in 1 CARTON (58602-853-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-853-98 58602-853 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20221101 N/A ANDA ANDA210453 Aurohealth LLC GUAIFENESIN 600 mg/1 5 BLISTER PACK in 1 CARTON (58602-853-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
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