FDA.reportPublic FDA data

Application 211075

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-8010Allergy ReliefFexofenadine HClWalgreensANDACurrent
0363-8010Allergy ReliefFexofenadine HClWalgreensANDACurrent
0363-8010Allergy ReliefFexofenadine HClWalgreensANDACurrent
21130-821Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
21130-821Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
36800-653Allergy ReliefFexofenadine HydrochlorideTOPCO ASSOCIATES LLCANDACurrent
36800-653Allergy ReliefFexofenadine HydrochlorideTOPCO ASSOCIATES LLCANDACurrent
36800-653Allergy ReliefFexofenadine HydrochlorideTOPCO ASSOCIATES LLCANDACurrent
36800-761Allergy ReliefFexofenadine HydrochlorideTOPCO ASSOCIATES LLCANDACurrent
37808-391Allergy ReliefFexofenadine HydrochlorideHEBANDACurrent
37808-392Allergy ReliefFexofenadine HydrochlorideHEBANDACurrent
41163-292allergy reliefFexofenadine HydrochlorideUNFIANDACurrent
53943-392Allergy ReliefFexofenadine HydrochlorideDISCOUNT DRUG MARTANDACurrent
57344-292Allergy ReliefFexofenadine HydrochlorideAAA PHARMACEUTICAL, INC.ANDACurrent
57344-292Allergy ReliefFexofenadine HydrochlorideAAA PHARMACEUTICAL, INC.ANDACurrent
57344-292Allergy ReliefFexofenadine HydrochlorideAAA PHARMACEUTICAL, INC.ANDACurrent
62207-765Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
62207-765Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
62207-765Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
62207-765Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
62207-766Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
62207-766Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
62207-766Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
62207-766Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules India LtdANDACurrent
63868-334Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-334Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63941-801Allergy ReliefFexofenadine HClBest Choice (Valu Merchandisers Company)ANDACurrent
67091-386Allergy ReliefFexofenadine HClWinCo FoodsANDACurrent
68016-887Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG CONSORTIUMANDACurrent
68016-887Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG CONSORTIUMANDACurrent
68998-292Allergy ReliefFexofenadine HydrochlorideMARC GLASSMAN, INC.ANDACurrent
68998-292Allergy ReliefFexofenadine HydrochlorideMARC GLASSMAN, INC.ANDACurrent
69168-413Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-413Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-437Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-437Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-437Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69842-492Allergy ReliefFexofenadine HydrochlorideCVS PHARMACYANDACurrent
70000-058612HR Allergy ReliefFexofenadine HydrochlorideCARDINAL HEALTHANDACurrent
70692-134Fexofenadine hydrochlorideFexofenadine hydrochlorideStrive Pharmaceuticals IncANDACurrent
70692-134Fexofenadine hydrochlorideFexofenadine hydrochlorideStrive Pharmaceuticals IncANDACurrent
71288-407GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71288-408GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71309-091Fexofenadine HydrochlorideFexofenadine HydrochlorideSafrel Pharmaceuticals, LLC.ANDACurrent
72036-191Allergy ReliefFexofenadine HydrochlorideHARRIS TEETERANDACurrent
72036-292Allergy ReliefFexofenadine HydrochlorideHARRIS TEETERANDACurrent
72036-292Allergy ReliefFexofenadine HydrochlorideHARRIS TEETERANDACurrent
72476-192ALLERGY RELIEFFexofenadine HydrochlorideRETAIL BUSINESS SERVICES , LLC.ANDACurrent
79903-090Allergy ReliefFexofenadine HClWALMART INC.ANDACurrent
79903-090Allergy ReliefFexofenadine HClWALMART INC.ANDACurrent
80539-801Allergy ReliefFexofenadine HClAllwell Health IncANDACurrent
80539-801Allergy ReliefFexofenadine HClAllwell Health IncANDACurrent
81522-613Allergy ReliefFexofenadine HClFSA Store Inc.ANDACurrent
81522-613Allergy ReliefFexofenadine HClFSA Store Inc. (Caring Mills)ANDACurrent