FDA.reportPublic FDA data

Application 077946

Type
ANDA
Sponsor
PLD ACQUISITIONS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7522CetirizineCetirizine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-1683Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-1683Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-1684Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-1684Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
21695-709Cetirizine HydrochlorideCetirizine HydrochlorideRebel Distributors CorpANDACurrent
52959-923CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEH. J. Harkins Company Inc.ANDACurrent
55910-039All Day Allergy ReliefCetirizine HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-039All Day Allergy ReliefCetirizine HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-039All Day Allergy ReliefCetirizine HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-739All Day AllergyCetirizine HCLP & L Development, LLCANDACurrent
59726-739All Day AllergyCetirizine HCLP & L Development, LLCANDACurrent
62011-0408All Day AllergyCetirizine HCLMcKesson (Health Mart)ANDACurrent
63548-0739Indoor outdoor allergiesCetirizine HClPLD Acquisitions LLC DBA AvANDACurrent
66336-336Cetirizine HydrochlorideCetirizine HydrochlorideDispensing Solutions, Inc.ANDACurrent
68788-6905Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6905Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0664Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0777Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0028Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0028Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9098ORIG2008-01-09
39544ORIG2008-01-08