FDA.report

Application 206941

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0474Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0474Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0474Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0474Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0474Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0510Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0510Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0510Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0510Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
0363-0510Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWALGREEN CO.ANDACurrent
11673-611mucus relief DMGuaifenesin and Dextromethorphan HBrTarget CorporationANDACurrent
11673-611mucus relief DMGuaifenesin and Dextromethorphan HBrTarget CorporationANDACurrent
11673-611mucus relief DMGuaifenesin and Dextromethorphan HBrTarget CorporationANDACurrent
11673-611mucus relief DMGuaifenesin and Dextromethorphan HBrTarget CorporationANDACurrent
21130-989Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-989Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-989Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-989Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-989Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-997MUCUS RELIEF DMGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-997MUCUS RELIEF DMGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-997MUCUS RELIEF DMGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-997MUCUS RELIEF DMGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
21130-997MUCUS RELIEF DMGuaifenesin and Dextromethorphan HBrBetter Living Brands LLCANDACurrent
41163-030Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
41163-030Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
41163-030Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
41163-030Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
41163-985Maximum Strength Mucus-DMGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
41163-985Maximum Strength Mucus-DMGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
41163-985Maximum Strength Mucus-DMGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
41163-985Maximum Strength Mucus-DMGuaifenesin and Dextromethorphan HBrSUPERVALU INCANDACurrent
46122-420Mucus DMGuaifenesin and Dextromethorphan HBrAmerisource BergenANDACurrent
46122-420Mucus DMGuaifenesin and Dextromethorphan HBrAmerisource BergenANDACurrent
46122-420Mucus DMGuaifenesin and Dextromethorphan HBrAmerisource BergenANDACurrent
46122-420Mucus DMGuaifenesin and Dextromethorphan HBrAmerisource BergenANDACurrent
49035-956Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
49035-956Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
49035-956Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
49035-956Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
49035-960Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
49035-960Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
49035-960Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
49035-960Mucus Relief DMGuaifenesin and Dextromethorphan HBrWal-Mart Stores, Inc.ANDACurrent
50066-004TUKOL MAX ACTION DM MAXGuaifenesin and Dextromethorphan HBrGenomma Lab USA IncANDACurrent
50066-004TUKOL MAX ACTION DM MAXGuaifenesin and Dextromethorphan HBrGenomma Lab USA IncANDACurrent
50066-004TUKOL MAX ACTION DM MAXGuaifenesin and Dextromethorphan HBrGenomma Lab USA IncANDACurrent
55315-053Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrFred's, Inc.ANDACurrent
55315-053Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrFred's, Inc.ANDACurrent
55315-053Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrFred's, Inc.ANDACurrent
55315-053Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBrFred's, Inc.ANDACurrent
55319-987Mucus Relief DMGuaifenesin and Dextromethorphan HBrFamily Dollar, Inc.ANDACurrent
55319-987Mucus Relief DMGuaifenesin and Dextromethorphan HBrFamily Dollar, Inc.ANDACurrent
55319-987Mucus Relief DMGuaifenesin and Dextromethorphan HBrFamily Dollar, Inc.ANDACurrent
55319-987Mucus Relief DMGuaifenesin and Dextromethorphan HBrFamily Dollar, Inc.ANDACurrent
55319-987Mucus Relief DMGuaifenesin and Dextromethorphan HBrFamily Dollar, Inc.ANDACurrent
55910-992Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
55910-992Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
55910-992Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
55910-992Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
55910-993Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
55910-993Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
55910-993Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
55910-993Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBrDolgencorp, LLCANDACurrent
58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-715Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-715Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-715Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-715Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-715Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-824Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-824Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-824Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-824Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent
58602-825Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrAurohealth LLCANDACurrent