FDA.reportPublic FDA data

Application 076471

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINELORATADINETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0536-1092LORATADINELoratadineRugby LaboratoriesANDACurrent
0536-1092LORATADINELoratadineRugby LaboratoriesANDACurrent
0904-5793LORATADINELoratadineMajor PharmaceuticalsANDACurrent
0904-5793LORATADINELoratadineMajor PharmaceuticalsANDACurrent
10544-455LoratadineLoratadineBlenheim Pharmacal, Inc.ANDACurrent
24286-1568Allergy ReliefLoratadineDLC LABORATORIES, INCANDACurrent
50090-0838LoratadineLoratadineA-S Medication SolutionsANDACurrent
50090-0838LoratadineLoratadineA-S Medication SolutionsANDACurrent
50268-488LoratadineLoratadineAvPAKANDACurrent
53117-309Allergy ReliefLoratadineFirst Aid DirectANDACurrent
53117-407Allergy ReliefLoratadineFirst Aid DirectANDACurrent
57896-788Allergy reliefLoratadineGeri-Care Pharmaceutical CorpANDACurrent
57896-788Allergy reliefLoratadineGeri-Care Pharmaceutical CorpANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-4649LORATADINELoratadineApotex Corp.ANDACurrent
60505-4649LORATADINELoratadineApotex Corp.ANDACurrent
63654-309AllergyLoratadineSelder, S.A. de C.V.ANDACurrent
63654-309AllergyLoratadineSelder, S.A. de C.V.ANDACurrent
68071-4318Allergy reliefLoratadineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4318Allergy reliefLoratadineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7085LORATADINELoratadinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7085LORATADINELoratadinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7085LORATADINELoratadinePreferred Pharmaceuticals Inc.ANDACurrent
68998-309Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-309Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-309Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-407Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
69168-309Allergy ReliefLoratadineAllegiant HealthANDACurrent
69168-309Allergy ReliefLoratadineAllegiant HealthANDACurrent
69168-309Allergy ReliefLoratadineAllegiant HealthANDACurrent
70000-0317LORATADINELoratadineCardinal HealthANDACurrent
70000-0317LORATADINELoratadineCardinal HealthANDACurrent
70518-1262LORATADINELoratadineREMEDYREPACK INC.ANDACurrent
70518-1262LORATADINELoratadineREMEDYREPACK INC.ANDACurrent