FDA.reportPublic FDA data

Application 077829

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoYes
003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-8301Cetirizine HydrochlorideCetirizine HydrochlorideKaiser Foundation HospitalsANDACurrent
0179-8302Cetirizine HydrochlorideCetirizine HydrochlorideKaiser Foundation HospitalsANDACurrent
10544-670Cetirizine HydrochlorideCetirizine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
16571-401Cetirizine HydrochlorideCetirizine HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
16571-401Cetirizine HydrochlorideCetirizine HydrochlorideRising Pharma Holdings, Inc.ANDACurrent
16571-402Cetirizine HydrochlorideCetirizine HydrochlorideRising Pharma Holdings, Inc.ANDACurrent
16571-402Cetirizine HydrochlorideCetirizine HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
33261-393Cetirizine HydrochlorideCetirizine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
35356-864Cetirizine HydrochlorideCetirizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-864Cetirizine HydrochlorideCetirizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-864Cetirizine HydrochlorideCetirizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
46994-658Allergy ReliefCetirizine HydrochlorideSAVE-A-LOT FOOD STORES, LTD.ANDACurrent
46994-658Allergy ReliefCetirizine HydrochlorideSAVE-A-LOT FOOD STORES, LTD.ANDACurrent
50090-1089Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1089Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
53002-1259Cetirizine HydrochlorideCetirizine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1259Cetirizine HydrochlorideCetirizine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-331Cetirizine HydrochlorideCetirizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-331Cetirizine HydrochlorideCetirizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-429CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-429CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-429CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-538Cetirizine HydrochlorideCetirizine HydrochlorideDIRECT RXANDACurrent
61919-538CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-538CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-538CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-538CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEDirect_RxANDACurrent
63629-4914Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-4914Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-4914Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8041Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8041Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
67296-1085Cetirizine HydrochlorideCetirizine HydrochlorideRedPharm DrugANDACurrent
67296-1085Cetirizine HydrochlorideCetirizine HydrochlorideRedPharm DrugANDACurrent
67668-161Cetirizine HydrochlorideCetirizine HydrochlorideUnique Pharmaceutical LaboratoriesANDACurrent
67668-162Cetirizine HydrochlorideCetirizine HydrochlorideUnique Pharmaceutical LaboratoriesANDACurrent
68071-1964Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1964Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68210-0450Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-1190Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-1190Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4112Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4112Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4112Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4136Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4136Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4136Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4159Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4159Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4159Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68788-0790Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0790Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0790Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0790Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0790Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0182Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-199Cetirizine HydrochlorideCetirizine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-199Cetirizine HydrochlorideCetirizine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-199Cetirizine HydrochlorideCetirizine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70985-001Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
70985-001Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
70985-001Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
70985-001Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
70985-002Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
70985-002Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
70985-002Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
70985-002Cetirizine HydrochlorideCetirizine HydrochlorideDrug Ocean LLCANDACurrent
71205-093Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-093Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-164Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-164Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71335-0300Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0300Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent