FDA.reportPublic FDA data

Application 078780

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0129Wal-ZyrCetirizine HClWalgreensANDACurrent
0536-4088Cetirizine HydrochlorideCetirizine hydrochlorideRugby Laboratories, Inc.ANDACurrent
33992-0129All Day Allergy ReliefCetirizine HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
41520-129All Day AllergyCetirizine HClCare One (American Sales Company)ANDACurrent
49348-984All Day Allergy ReliefCetirizine HClMcKesson (Sunmark)ANDACurrent
49348-984All Day Allergy ReliefCetirizine HClStrategic Sourcing Services LLCANDACurrent
53187-129All Day AllergyCetirizine HClLIVE BETTER (The Great Atlantic & Pacific Tea Company)ANDACurrent
55315-129Cetirizine HCL 10 mg All Day Allergy ReliefCetirizine HydrochlorideFreds IncANDACurrent
55315-129Cetirizine HCL 10 mg All Day Allergy ReliefCetirizine HydrochlorideFreds IncANDACurrent
55910-129Allergy ReliefCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-129Allergy ReliefCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-129Allergy ReliefCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-129Allergy ReliefCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-024All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-129All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-129All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-129All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-129All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
62011-005224-Hour All Day AllergyCetirizine HClMcKessonANDACurrent
62011-0205All Day AllergyCetirizine HClMcKesson (Health Mart)ANDACurrent
62011-0205All Day AllergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0552All Day AllergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0552All Day AllergyCetirizine HClMcKesson (Health Mart)ANDACurrent
62011-0552All Day AllergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
65162-045Cetirizine HydrochlorideCetirizineAmneal PharmaceuticalsANDACurrent
65162-046Cetirizine HydrochlorideCetirizineAmneal PharmaceuticalsANDACurrent
65162-145Cetirizine HydrochlorideCetirizineAmneal PharmaceuticalsANDACurrent
65162-146Cetirizine HydrochlorideCetirizineAmneal PharmaceuticalsANDACurrent
66715-685024 Hour AllergyCetirizine hydrochlorideLil' Drug Store Products, IncANDACurrent
66715-685024 Hour AllergyCetirizine hydrochlorideLil' Drug Store Products, IncANDACurrent
70000-0148Allergy ReliefCetirizine HClCardinal Health (Leader) 70000ANDACurrent
70000-0148Allergy ReliefCetirizine HClCardinal Health (Leader) 70000ANDACurrent
70000-0148Allergy ReliefCetirizine HClCardinal Health (Leader) 70000ANDACurrent
70253-129All Day Allergy ReliefCetirizine HClOUR FAMILY (NASH FINCH COMPANY)ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9182ORIG2010-01-26