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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077946-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A077946-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A077946-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077946-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077946-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27e64feba35796…
2022-09-29 23:25 UTC2022-09A077946-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077946-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077946-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077946-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077946-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day Allergy ReliefCETIRIZINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)76ec3257-9206-4a0f-a2cf-8a05217b92e72025-07-01WarningsExact identifier
application applno (ANDA): 077946
application number: ANDA077946
ndc (product): 55910-039
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inc760dd0e4-280a-4d95-8938-cecaa7ec75f22013-06-03WarningsExact identifier
application applno (ANDA): 077946
application number: ANDA077946
ndc (product): 0781-1684

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

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