FDA.reportPublic FDA data

Application 078488

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-924Cetirizine HydrochlorideCetirizine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
50090-2084Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2084Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2084Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
51991-837Cetirizine HydrochlorideCetirizine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-837Cetirizine HydrochlorideCetirizine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-837Cetirizine HydrochlorideCetirizine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-837Cetirizine HydrochlorideCetirizine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
53217-163Cetirizine HydrochlorideCetirizine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
63187-436Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63187-436Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63629-2060Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2060Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
68151-3708Cetirizine HydrochlorideCetirizine HydrochlorideCarilion Materials ManagementANDACurrent
68788-9493Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent