美国FDA药品数据库-药物在线

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
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	209692	002	ANDA	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	60MG;1.2GM	No	No	2018/11/01	2018/11/01	AMNEAL PHARMS	Over-the-counter
GUAIFENESIN	210453	001	ANDA	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No	2019/10/21	2019/10/21	AUROBINDO PHARMA	Over-the-counter
GUAIFENESIN	210453	002	ANDA	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	1.2GM	No	No	2019/10/21	2019/10/21	AUROBINDO PHARMA	Over-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	213203	001	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No	2020/03/25	2020/03/25	AUROBINDO PHARMA LTD	Over-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	213203	002	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	No	No	2020/03/25	2020/03/25	AUROBINDO PHARMA LTD	Over-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	212542	001	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No	2020/04/28	2020/04/28	SUN PHARM INDS INC	Over-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	212542	002	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	No	No	2020/04/28	2020/04/28	SUN PHARM INDS INC	Over-the-counter
GUAIFENESIN	213420	001	ANDA	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No	2020/05/08	2020/05/08	GRANULES	Over-the-counter
GUAIFENESIN	213420	002	ANDA	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	1.2GM	No	No	2020/05/08	2020/05/08	GRANULES	Over-the-counter
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	214781	001	ANDA	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	30MG;600MG	No	No	2021/07/01	2021/07/01	SUN PHARM	Over-the-counter
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	214781	002	ANDA	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	60MG;1.2GM	No	No	2021/07/01	2021/07/01	SUN PHARM	Over-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	214407	001	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No	2022/02/01	2022/02/01	L PERRIGO CO	Over-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	214407	002	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	No	No	2022/02/01	2022/02/01	L PERRIGO CO	Over-the-counter
GUAIFENESIN	215932	001	ANDA	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No	2022/03/15	2022/03/15	DR REDDYS	Over-the-counter
GUAIFENESIN	215932	002	ANDA	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	1.2GM	No	No	2022/03/15	2022/03/15	DR REDDYS	Over-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	216082	001	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No	2022/08/22	2022/08/22	GRANULES	Discontinued
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	216082	002	ANDA	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	No	No	2022/08/22	2022/08/22	GRANULES	Discontinued
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	217340	001	ANDA	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	30MG;600MG	No	No	2023/08/01	2023/08/01	DR REDDYS	Over-the-counter
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	217340	002	ANDA	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	60MG;1.2GM	No	No	2023/08/01	2023/08/01	DR REDDYS	Over-the-counter
GUAIFENESIN	217780	001	ANDA	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No	2023/08/21	2023/08/21	MARKSANS PHARMA	Over-the-counter