FDA.report

Application 207602

Type
ANDA
Sponsor
PERRIGO R AND D

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, GuaifenesinGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, GuaifenesinWyeth Consumer Healthcare LLCANDACurrent
0113-0812good sense mucus dmdextromethorphan HBr, guaifenesinL Perrigo CompanyANDACurrent
0113-0812good sense mucus dmdextromethorphan HBr, guaifenesinL Perrigo CompanyANDACurrent
0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesinL. Perrigo CompanyANDACurrent
0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesinL. Perrigo CompanyANDACurrent
0113-7419basic care mucus dmdextromethorphan hydrobromide, guaifenesinL. Perrigo CompanyANDACurrent
0113-7812basic care mucus dmdextromethorphan HBr, guaifenesinL. Perrigo CompanyANDACurrent
0113-7812basic care mucus dmdextromethorphan HBr, guaifenesinL. Perrigo CompanyANDACurrent
0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, GuaifenesinBayer HealthCare LLC.ANDACurrent
0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, GuaifenesinBayer HealthCare LLC.ANDACurrent
0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, GuaifenesinBayer HealthCare LLC.ANDACurrent
0363-6812mucus relief dmdextromethorphan hydrobromide, guaifenesinWalgreen CompanyANDACurrent
0536-1199rugby mucus relief dmdextromethorphan HBr, guaifenesinRugby LaboratoriesANDACurrent
11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
11673-716up and up mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
11673-716up and up mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
36800-219Topcare Mucus DMdextromethorphan hydrobromide, guaifenesinTopco Associates LLCANDACurrent
36800-219Topcare Mucus DMdextromethorphan hydrobromide, guaifenesinTopco Associates LLCANDACurrent
36800-592Topcare Mucus DMdextromethorphan HBr, guaifenesinTopco Associates LLCANDACurrent
36800-592Topcare Mucus DMdextromethorphan HBr, guaifenesinTopco Associates LLCANDACurrent
37808-812mucus relief dmdextromethorphan HBr, guaifenesinH E BANDACurrent
41163-599equaline mucus dmdextromethorphan hydrobromide, guaifenesinSupervalu IncANDACurrent
41163-781Equaline Mucus DMdextromethorphan HBr, guaifenesinSupervalu IncANDACurrent
41250-436mucus relief dmdextromethorphan hydrobromide, guaifenesinMeijer Distribution IncANDACurrent
41250-812mucus dmdextromethorphan HBr, guaifenesinMeijer Distribution IncANDACurrent
46122-637good neighbor pharmacy mucus dmdextromethorphan HBr, guaifenesinAmerisource BergenANDACurrent
50594-812sound body mucus dmdextromethorphan Hydrobromide, guaifenesinBig Lots Stores, Inc.ANDACurrent
55301-812Exchange Select Mucus DMdextromethorphan HBr, guaifenesinArmy & Air Force Exchange ServiceANDACurrent
55910-575DG health mucus dmdextromethorphan HBr, guaifenesinDolgencorp, LLCANDACurrent
55910-575DG health mucus dmdextromethorphan HBr, guaifenesinDolgencorp, LLCANDACurrent
55910-575DG health mucus dmdextromethorphan HBr, guaifenesinDolgencorp, LLCANDACurrent
68391-812Berkley and Jensen Mucus Relief DMdextromethorphan HBr, guaifenesinBJWCANDACurrent
69842-812mucus dm extended releaseguaifenesin, dextromethorphan HBrCVS PharmacyANDACurrent
69842-963mucus dm extended releaseguaifenesin, dextromethorphan hydrobromideCVS PharmacyANDACurrent
70000-0372Leader Mucus DMdextromethorphan HBr, guaifenesinCardinal HealthANDACurrent
70000-0372Leader Mucus DMdextromethorphan HBr, guaifenesinCardinal Health 110, LLC. dba LeaderANDACurrent
72288-219basic care mucus dmdextromethorphan hydrobromide, guaifenesinAmazon.com Services LLCANDACurrent
72288-812basic care mucus dmdextromethorphan HBr, guaifenesinAmazon.com Services LLCANDACurrent
79903-065equate mucus relief dmdextromethorphan hydrobromide, guaifenesinWal-Mart Stores IncANDACurrent
81522-812caring mill mucus dmdextromethorphan HBr, guaifenesinFSA Store Inc.ANDACurrent