FDA.reportPublic FDA data

Application 212542

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL600MG;60MGNoNo
002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1.2GM;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9930Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0536-1333Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideRUGBY LABORATORIES, INC.ANDACurrent
0536-1333Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideRUGBY LABORATORIES, INC.ANDACurrent
41415-994Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine HydrochloridePUBLIX SUPER MARKETS, INCANDACurrent
51316-970MAXIMUM STRENGTH Mucus Dguaifenesin and pseudoephedrine hydrochlorideCVS PharmacyANDACurrent
51316-993Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
51316-993Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
51316-993Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
51660-057Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClOhm Laboratories, Inc.ANDACurrent
51660-058Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClOhm Laboratories, Inc.ANDACurrent
62011-0475Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine HydrochlorideSTRATEGIC SOURCING SERVICES LLCANDACurrent
70000-0580Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCARDINAL HEALTH 110, LLC. DBA LEADERANDACurrent
70000-0580Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCARDINAL HEALTH 110, LLC. DBA LEADERANDACurrent
70000-0580Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCARDINAL HEALTH 110, LLC. DBA LEADERANDACurrent