FDA.reportPublic FDA data

Application 209116

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
0363-0094Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWALGREEN CO.ANDACurrent
0363-0094Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWALGREEN CO.ANDACurrent
0363-0094Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWALGREEN CO.ANDACurrent
0363-0094Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWALGREEN CO.ANDACurrent
0363-0094Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWALGREEN CO.ANDACurrent
30142-059Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideKROGER COMPANYANDACurrent
30142-059Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideKROGER COMPANYANDACurrent
51316-007Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
58602-807Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAurohealth LLCANDACurrent
58602-807Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAurohealth LLCANDACurrent
58602-807Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAurohealth LLCANDACurrent
58602-807Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAurohealth LLCANDACurrent
62011-0376Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideMcKESSON CorporationANDACurrent