FDA.report

Application 021620

Type
NDA
Sponsor
RB HLTH

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL60MG;1.2GMYesYes
002MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL30MG;600MGYesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0076Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromidewalgreensNDACurrent
11822-7156Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideRite-AidNDACurrent
11822-7156Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideRite-AidNDACurrent
11822-7156Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideRite-AidNDACurrent
17856-0056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideATLANTIC BIOLOGICALS CORPNDACurrent
17856-0056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideATLANTIC BIOLOGICALS CORPNDACurrent
17856-0056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideATLANTIC BIOLOGICALS CORP.NDACurrent
29485-6647MucinexDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINMechanical Servants LLCNDACurrent
29485-6647MucinexDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINMechanical Servants LLCNDACurrent
29485-6647MucinexDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINMechanical Servants LLCNDACurrent
29485-6942MucinexDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINMechanical Servants LLCNDACurrent
30142-706Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideKROGER COMPANYNDACurrent
30142-706Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideKROGER COMPANYNDACurrent
30142-706Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideKROGER COMPANYNDACurrent
30142-991Mucus Relief ER DMGuaifenesin and Dextromethorphan HydrobromideKROGER COMPANYNDACurrent
30142-991Mucus Relief ER DMGuaifenesin and Dextromethorphan HydrobromideKROGER COMPANYNDACurrent
49035-077Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideWALMART STORES, INC.NDACurrent
49035-077Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideWALMART STORES, INC.NDACurrent
50090-1077Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
50090-1077Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
50090-1077Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
50090-1078Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
50090-1078Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
50090-2298Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
50090-2298Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
50090-2299Mucinex DMGuaifenesin and Dextromethorphan HydrobromideA-S Medication SolutionsNDACurrent
51660-054Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideOHM LABORATORIES INCNDACurrent
51660-073Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideOHM LABORATORIES INCNDACurrent
52904-650Mucinex DMguaifenesin and dextromethorphan hydrobromideSelect CorporationNDACurrent
60687-651Mucinex DMGuaifenesin and Dextromethorphan HydrobromideAmerican Health PackagingNDACurrent
63824-056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideRB Health (US) LLCNDACurrent
63824-056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideRB Health (US) LLCNDACurrent
63824-056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideReckitt Benckiser LLCNDACurrent
63824-056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideRB Health (US) LLCNDACurrent
63824-056Mucinex DMGuaifenesin and Dextromethorphan HydrobromideRB Health (US) LLCNDACurrent
63824-072Mucinex DMGuaifenesin and Dextromethorphan HydrobromideReckitt Benckiser LLCNDACurrent
63824-072Mucinex DMGuaifenesin and Dextromethorphan HydrobromideRB Health (US) LLCNDACurrent
63824-072Mucinex DMGuaifenesin and Dextromethorphan HydrobromideRB Health (US) LLCNDACurrent
63824-072Mucinex DMGuaifenesin and Dextromethorphan HydrobromideRB Health (US) LLCNDACurrent
63868-391Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideCHAIN DRUG MARKETING ASSOCIATION INCNDACurrent
66715-9724Mucinex DMGuaifenesin and Dextromethorphan HydrobromideLil' Drug Store Products, Inc.NDACurrent
66715-9724Mucinex DMGuaifenesin and Dextromethorphan HydrobromideLil' Drug Store Products, Inc.NDACurrent
66715-9724Mucinex DMGuaifenesin and Dextromethorphan HydrobromideLil' Drug Store Products, Inc.NDACurrent
66715-9724Mucinex DMGuaifenesin and Dextromethorphan HydrobromideLil' Drug Store Products, Inc.NDACurrent
67751-171Mucinex DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINNavajo Manufacturing Company Inc.NDACurrent
67751-171Mucinex DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINNavajo Manufacturing Company Inc.NDACurrent
68196-073Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideSAM'S WEST INCNDACurrent
68788-6340Mucinex DMGuaifenesin and Dextromethorphan HydrobromidePreferred Pharmaceuticals Inc.NDACurrent
68788-6340Mucinex DMGuaifenesin and Dextromethorphan HydrobromidePreferred Pharmaceuticals Inc.NDACurrent
68788-6340Mucinex DMGuaifenesin and Dextromethorphan HydrobromidePreferred Pharmaceuticals Inc.NDACurrent

Documents

DocumentSubmission typeDate
79333SUPPL 2024-08-08
79332SUPPL 2024-08-08
66338SUPPL2021-02-23
66332SUPPL2021-02-23
64277SUPPL2020-08-13
57407SUPPL2019-02-01
50585SUPPL2017-12-04
50584SUPPL2017-12-01
28255SUPPL2014-03-07
5868SUPPL2014-03-07
5867SUPPL2009-04-09
37344SUPPL2007-09-07
28254SUPPL2007-09-07
5866SUPPL2006-01-30
42236ORIG2005-10-06
5865SUPPL2005-01-26
15881ORIG2004-05-04
28253ORIG2004-05-03