FDA.reportPublic FDA data

Application 209692

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL30MG;600MGNoNo
002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL60MG;1.2GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0437Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrWalgreensANDACurrent
0363-0437Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrWalgreensANDACurrent
0363-0437Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrWalgreensANDACurrent
0363-0733Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrWalgreensANDACurrent
0363-0733Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrWalgreensANDACurrent
0363-0733Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrWalgreensANDACurrent
0536-1161Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrRugby Laboratories, Inc.ANDACurrent
0536-1161Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrRugby Laboratories, Inc.ANDACurrent
0536-1161Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrRugby Laboratories, Inc.ANDACurrent
0536-1161Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrRugby Laboratories, Inc.ANDACurrent
0536-1213Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrRugby Laboratories, Inc.ANDACurrent
0536-1213Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrRugby Laboratories, Inc.ANDACurrent
0536-1213Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrRugby Laboratories, Inc.ANDACurrent
11673-833Mucus Relief DM Extended ReleaseGuaifenesin, Dextromethorphan HBrTARGET CorporationANDACurrent
11673-833Mucus Relief DM Extended ReleaseGuaifenesin, Dextromethorphan HBrTARGET CorporationANDACurrent
11673-833Mucus Relief DM Extended ReleaseGuaifenesin, Dextromethorphan HBrTARGET CorporationANDACurrent
11673-834Mucus Relief DM MAXDextromethorphan HBr, GuaifenesinTARGET CorporationANDACurrent
11673-834Mucus Relief DM MAXDextromethorphan HBr, GuaifenesinTARGET CorporationANDACurrent
11673-834Mucus Relief DM MAXDextromethorphan HBr, GuaifenesinTARGET CorporationANDACurrent
11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
11822-7340Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
11822-7340Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
11822-7340Mucus Relief DMGuaifenesin, Dextromethorphan HBrRite Aid CorporationANDACurrent
37012-729Mucus Relief DMGuaifenesin, Dextromethorphan HBrShopko Stores Operating Co., LLC.ANDACurrent
37012-729Mucus Relief DMGuaifenesin, Dextromethorphan HBrShopko Stores Operating Co., LLC.ANDACurrent
37012-729Mucus Relief DMGuaifenesin, Dextromethorphan HBrShopko Stores Operating Co., LLC.ANDACurrent
37012-730Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrShopko Stores Operating Co., LLC.ANDACurrent
37012-730Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrShopko Stores Operating Co., LLC.ANDACurrent
37012-730Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrShopko Stores Operating Co., LLC.ANDACurrent
41250-633Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrMEIJER, INC.ANDACurrent
41250-633Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrMEIJER, INC.ANDACurrent
41250-934Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrMEIJER, INC.ANDACurrent
41250-934Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrMEIJER, INC.ANDACurrent
49035-824Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-824Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-825Mucus Relief DMGuaifenesin, Dextromethorphan HBrEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-825Mucus Relief DMGuaifenesin, Dextromethorphan HBrEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
50090-6020Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrA-S Medication SolutionsANDACurrent
55910-634Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-634Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-634Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-634Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-634Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrP & L Development, LLCANDACurrent
59726-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrP & L Development, LLCANDACurrent
59726-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrP & L Development, LLCANDACurrent
59726-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrP & L Development, LLCANDACurrent
59726-833Mucus DM Extended ReleaseDextromethorphan Hydrobromide and GuaifenesinP & L Development, LLCANDACurrent
59726-833Mucus DM Extended ReleaseDextromethorphan Hydrobromide and GuaifenesinP & L Development, LLCANDACurrent
59726-834Mucus DM Extended-ReleaseDextromethorphan Hydrobromide and GuaifenesinP & L Development, LLCANDACurrent
59726-834Mucus DM Extended-ReleaseDextromethorphan Hydrobromide and GuaifenesinP & L Development, LLCANDACurrent
62011-0423Mucus Relief DMGuaifenesin, Dextromethorphan HBrStrategic Sourcing Services LLCANDACurrent
62011-0423Mucus Relief DMGuaifenesin, Dextromethorphan HBrStrategic Sourcing Services LLCANDACurrent
62011-0424Mucus Relief DMGuaifenesin, Dextromethorphan HBrStrategic Sourcing Services LLCANDACurrent
62011-0424Mucus Relief DMGuaifenesin, Dextromethorphan HBrStrategic Sourcing Services LLCANDACurrent
63868-870Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-870Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBrQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63941-733Mucus Relief DMGuaifenesin, Dextromethorphan HBrBest Choice (Valu Merchandisers Company)ANDACurrent
63941-734Mucus Relief DMGuaifenesin, Dextromethorphan HBrBest Choice (Valu Merchandisers Company)ANDACurrent
65162-038Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
65162-038Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
65162-038Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
65162-038Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
65162-039Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
65162-039Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
65162-039Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
65162-039Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAmneal Pharmaceuticals LLCANDACurrent
67091-344Mucus Relief DMGuaifenesin, Dextromethorphan HBrWinCo Foods, LLCANDACurrent
67091-344Mucus Relief DMGuaifenesin, Dextromethorphan HBrWinCo Foods, LLCANDACurrent
67091-344Mucus Relief DMGuaifenesin, Dextromethorphan HBrWinCo Foods, LLCANDACurrent
67091-345Mucus Relief DMGuaifenesin, Dextromethorphan HBrWinCo Foods, LLCANDACurrent