FDA.report

Application 090760

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
004CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9602Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
0363-9602Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
10202-715Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride7-ElevenANDACurrent
10202-715Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride7-ElevenANDACurrent
16714-799Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideNorthStar Rx LLCANDACurrent
16714-799Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideNorthStar Rx LLCANDACurrent
16714-799Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideNorthStar Rx LLCANDACurrent
30142-172Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideKROGER COMPANYANDACurrent
30142-172Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideKROGER COMPANYANDACurrent
55315-007Cetirizine Hydrochloride (Allergy Relief)Cetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-007Cetirizine Hydrochloride (Allergy Relief)Cetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-007Cetirizine Hydrochloride (Allergy Relief)Cetirizine HydrochlorideFred's, Inc.ANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-446Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-446Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-446Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-447Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-447Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-447Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-813Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-813Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-813Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-823Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-823Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-823Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
62011-0313all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0313all day allergyCetirizine HClMcKESSON CorporationANDACurrent
62011-0313all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
68001-436Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideBluePoint LaboratoriesANDACurrent
68001-436Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideBluePoint LaboratoriesANDACurrent
68071-2482Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
70000-0047Cetirizine HydrochlorideCetirizine Hydrochloride AllergyCardinal HealthANDACurrent
70000-0047Cetirizine HydrochlorideCetirizine Hydrochloride AllergyCardinal HealthANDACurrent
70000-0047Cetirizine HydrochlorideCetirizine Hydrochloride AllergyCardinal HealthANDACurrent
70677-0006all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
70677-0006all day allergyCetirizine HClMcKESSON CorporationANDACurrent
70677-0006all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
80539-002Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAllwell Health IncANDACurrent