FDA.reportPublic FDA data

Application 090818

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL60MG;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-2110Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochloridewalgreensANDACurrent
37808-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideH E BANDACurrent
41415-995Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloridefexofenadine hydrochloride and pseudoephedrine hydrochloridePUBLIX SUPER MARKETS, INCANDACurrent
46122-452Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAmeriSource BergenANDACurrent
46122-694Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAmeriSource BergenANDACurrent
47335-724Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
51660-037Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
56062-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochloridePUBLIX SUPER MARKETS INCANDACurrent
56062-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochloridePUBLIX SUPER MARKETS INCANDACurrent
69842-973Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS PharmacyANDACurrent
69842-990Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideCVS PharmacyANDACurrent