FDA.reportPublic FDA data

Application 204097

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6978Allergy ReliefFexofenadine HCLMajor PharmaceuticalsANDACurrent
0904-6978Allergy ReliefFexofenadine HCLMajor PharmaceuticalsANDACurrent
16714-899Fexofenadine HCLFexofenadine HCLNorthStar RxLLCANDACurrent
16714-899Fexofenadine HCLFexofenadine HCLNorthStar RxLLCANDACurrent
21130-064Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
21130-064Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
21130-064Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
41250-564Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
41250-564Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
41250-564Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
49035-366equate allergy relieffexofenadine hydrochlorideWalmart Inc.ANDACurrent
49035-366equate allergy relieffexofenadine hydrochlorideWalmart Inc.ANDACurrent
49035-366equate allergy relieffexofenadine hydrochlorideWalmart Inc.ANDACurrent
49035-504Allergy ReliefFexofenadine HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-504Allergy ReliefFexofenadine HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-504Allergy ReliefFexofenadine HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4267Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4267Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
55700-848Fexofenadine HCLFexofenadine HCLQuality Care Products, LLCANDACurrent
55700-848Fexofenadine HCLFexofenadine HCLQuality Care Products, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
63548-0662Childrens Allergy ReliefFexofenadine HCLPLD Acquisitions LLC DBA AvANDACurrent
63548-0663Allergy ReliefFexofenadine HClPLD Acquisitions LLC DBA AvANDACurrent
63548-0664Allergy ReliefFexofenadine HClPLD Acquisitions LLC DBA AvANDACurrent
63629-7997Fexofenadine HCLFexofenadine HCLBryant Ranch PrepackANDACurrent
63941-064Allergy ReliefFexofenadine HCLBest Choice (Valu Merchandisers Company)ANDACurrent
63941-064Allergy ReliefFexofenadine HCLBest Choice (Valu Merchandisers Company)ANDACurrent
63941-064Allergy ReliefFexofenadine HCLBest Choice (Valu Merchandisers Company)ANDACurrent
68071-2682Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2682Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4846Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4846Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68554-5061Fexofenadine HydrochlorideFexofenadine HydrochlorideHetero Labs LimitedANDACurrent
68554-5062Fexofenadine HydrochlorideFexofenadine HydrochlorideHetero Labs LimitedANDACurrent
68554-5063Fexofenadine HydrochlorideFexofenadine HydrochlorideHetero Labs LimitedANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
69230-300Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
69230-300Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
69230-301Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
69230-301Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
70934-601Fexofenadine HCLFexofenadine HCLDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-610Fexofenadine HCLFexofenadine HCLDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-531Fexofenadine HCLFexofenadine HCLProficient Rx LPANDACurrent
71205-531Fexofenadine HCLFexofenadine HCLProficient Rx LPANDACurrent
71335-1217Fexofenadine HCLFexofenadine HCLBryant Ranch PrepackANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
72090-061Fex-Allergy ReliefFexofenadine HClPioneer Life Sciences, LLCANDACurrent
72189-305FexofenadineFexofenadineDirectRxANDACurrent
72789-196Fexofenadine HCLFexofenadine HCLPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-196Fexofenadine HCLFexofenadine HCLPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-196Fexofenadine HCLFexofenadine HCLPD-Rx Pharmaceuticals, Inc.ANDACurrent