FDA.reportPublic FDA data

Application 091070

Type
ANDA
Sponsor
ACTAVIS LABS FL

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
0363-0735Mucus Relief DMDextromethorphan HBr, GuaifenesinWalgreen CompanyANDACurrent
0363-0735Mucus Relief DMDextromethorphan HBr, GuaifenesinWalgreen CompanyANDACurrent
11673-735Up and Up Mucus Relief DMDextromethorphan HBr, GuaifenesinTarget CorporationANDACurrent
11822-0735mucus relief DMDextromethorphan HBr, GuaifenesinRite Aid CorporationANDACurrent
21130-115Signature Care Mucus Relief DMDextromethorphan HBr, GuaifenesinSafewayANDACurrent
30142-735Mucus DM MaxDextromethorphan HBr, GuaifenesinKroger CompanyANDACurrent
36800-735TopCare Mucus DMDextromethorphan HBr, GuaifenesinTopco Associates LLCANDACurrent
37012-806Mucus DM MaxDextromethorphan HBr, GuaifenesinShopko Stores Operating Co., LLCANDACurrent
41163-735Equaline Mucus DMDextromethorphan HBr, GuaifenesinSupervalu IncANDACurrent
41250-735Mucus DMDextromethorphan HBr, GuaifenesinMeijer Distribution IncANDACurrent
46122-348Good Neighbor Pharmacy Mucus DMDextromethorphan HBr, GuaifenesinAmerisource BergenANDACurrent
49035-735Equate Mucus DMDextromethorphan HBr, GuaifenesinWal-Mart Stores IncANDACurrent
49348-199Sunmark mucus relief DMDextromethorphan HBr, GuaifenesinMckessonANDACurrent
49348-199Sunmark mucus relief DMDextromethorphan HBr, GuaifenesinStrategic Sourcing Services LLCANDACurrent
55316-735Healthy Accents Mucus Relief DMDextromethorphan HBr, GuaifenesinDZA Brands LLCANDACurrent
55910-735DG Health Mucus DMDextromethorphan HBr, GuaifenesinDolgencorp, LLCANDACurrent
59779-735Mucus DM Extended ReleaseDextromethorphan HBr, GuaifenesinCVS PharmacyANDACurrent
62011-0302Health Mart mucus relief DMDextromethorphan HBr, GuaifenesinMckessonANDACurrent
62011-0302Health Mart mucus relief DMDextromethorphan HBr, GuaifenesinStrategic Sourcing Services LLCANDACurrent
68196-735Members Mark mucus relief DMDextromethorphan HBr, GuaifenesinSam's West IncANDACurrent
69256-735Harris Teeter Mucus Relief DMDextromethorphan HBr, GuaifenesinHarris Teeter, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9316ORIG2015-09-04