Application 078336

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078336-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A078336-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE 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 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27d06236e962d9…

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Incb9ac489a-80ed-4077-b68e-d03df1b892a62026-07-28WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 55910-458
allergy reliefCETIRIZINE HYDROCHLORIDEH E B8649fc1e-ad56-4660-bbbb-8f1ed795697b2026-07-20WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEMajor Pharmaceuticals71db132d-dca4-47ef-8560-c68ad22589332026-05-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
All Day AllergyCETIRIZINE HYDROCHLORIDEHyVee Inc8889af37-8345-4358-994d-7d8b847f48742026-04-22WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC37c6d1e4-dd88-42a2-a828-539b68aa5dad2026-04-16WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Allergy Relief Indoor and Outdoor AllergiesCETIRIZINE HYDROCHLORIDECVS Pharmacy98f3f2c6-da18-4055-81f1-962261360f9b2026-03-31WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 59779-458
CetirizineCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack7e158fd6-268d-4ffc-a410-d054090d54c52026-03-19WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
BERKLEY AND JENSEN ALL DAY ALLERGYCETIRIZINE HYDROCHLORIDEBJWCb38c0068-5b06-4976-b68d-617bcc14f0512026-02-11WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEMajor Pharmaceuticalsa5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a32026-01-29WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a462f9c0-45ef-49b1-b0d8-a02a75a4b7312026-01-27WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Exchange select all day allergyCETIRIZINE HYDROCHLORIDEArmy & Air Force Exchange Servicee7220494-3640-4b33-b577-ed3ca7c483e82026-01-15WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 55301-076
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEL. Perrigo Company2a7a27ab-1b4c-40d1-98bf-e4297aa256822026-01-08WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDENorthwind Health Company, LLCf2b4d221-30ae-5a43-e053-2995a90a238a2026-01-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
TopCare All Day AllergyCETIRIZINE HYDROCHLORIDETopco Associates LLCf2919aad-9ed4-40b8-b233-4aec06df33ea2025-12-23WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Up and Up Allergy ReliefCETIRIZINE HYDROCHLORIDETarget Corporationce93ca5b-2a65-4873-9686-926c44076c6c2025-12-19WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsff782956-03b7-4ae6-b78f-fb7fe78b262d2025-12-05WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4a45672b-67d3-4739-86ec-0a6696dd83d42025-12-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 71610-123
signature care allergy reliefCETIRIZINE HYDROCHLORIDESafeway24099cbf-61ee-4ec8-a4ec-95a66ceaa0c02025-12-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
GOODNOW ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEGobrands, Inc86ade508-8841-47d8-addb-418ecd6dc8de2025-11-07WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEVERITYRX, LLC43f40b92-f0e0-8808-e063-6394a90a656b2025-10-30WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 153 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55301-076Exchange select all day allergyCetirizine HydrochlorideArmy & Air Force Exchange ServiceANDACurrent
55301-076Exchange select all day allergyCetirizine HydrochlorideArmy & Air Force Exchange ServiceANDACurrent
55316-458healthy accents cetirizine hydrochlorideCetirizine HydrochlorideDZA Brands LLCANDACurrent
55316-458healthy accents cetirizine hydrochlorideCetirizine HydrochlorideDZA Brands LLCANDACurrent
55316-586Healthy Accents allergy reliefCetirizine HydrochlorideDZA Brands LLCANDACurrent
55316-586Healthy Accents allergy reliefCetirizine HydrochlorideDZA Brands LLCANDACurrent
55910-458dg health all day allergyCetirizine HydrochlorideDolgencorp IncANDACurrent
55910-458dg health all day allergyCetirizine HydrochlorideDolgencorp IncANDACurrent
55910-458dg health all day allergyCetirizine HydrochlorideDolgencorp IncANDACurrent
55910-699rexall all day allergy reliefCetirizine HydrochlorideDolgencorp, LLCANDACurrent
55910-699rexall all day allergy reliefCetirizine HydrochlorideDolgencorp, LLCANDACurrent
55910-699rexall all day allergy reliefCetirizine HydrochlorideDolgencorp, LLCANDACurrent
59779-458Allergy ReliefCetirizine HydrochlorideCVS PharmacyANDACurrent
59779-458Allergy ReliefCetirizine HydrochlorideCVS PharmacyANDACurrent
59779-458Allergy ReliefCetirizine HydrochlorideCVS PharmacyANDACurrent
59779-458Allergy ReliefCetirizine HydrochlorideCVS PharmacyANDACurrent
63629-3708CetirizineCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
63940-043Core Values Allergy ReliefCetirizine HydrochlorideHarmon Stores Inc.ANDACurrent
63940-043Core Values Allergy ReliefCetirizine HydrochlorideHarmon Stores Inc.ANDACurrent
63940-458harmon face values allergy reliefCetirizine HydrochlorideHarmon Stores Inc.ANDACurrent
63940-458harmon face values allergy reliefCetirizine HydrochlorideHarmon Stores Inc.ANDACurrent
63981-458kirkland signature aller tecCetirizine HydrochlorideCostco Wholesale CompanyANDACurrent
63981-458kirkland signature aller tecCetirizine HydrochlorideCostco Wholesale CompanyANDACurrent
64024-499welby allergy reliefCetirizine HydrochlorideAldi IncANDACurrent
64024-499welby allergy reliefCetirizine HydrochlorideAldi IncANDACurrent
64024-499welby allergy reliefCetirizine HydrochlorideAldi IncANDACurrent
67046-680CetirizineCetirizineContract Pharmacy Services-PAANDACurrent
68196-458Members mark cetirizineCetirizine HydrochlorideSam's West IncANDACurrent
68196-458Members mark cetirizineCetirizine HydrochlorideSam's West IncANDACurrent
68196-458Members mark cetirizineCetirizine HydrochlorideSam's West IncANDACurrent
68196-502members mark aller zyrCetirizine HydrochlorideSam's West IncANDACurrent
68196-502members mark aller zyrCetirizine HydrochlorideSam's West IncANDACurrent
68391-500Berkley and Jensen Allergy ReliefCetirizine HydrochlorideBJWCANDACurrent
68391-500Berkley and Jensen Allergy ReliefCetirizine HydrochlorideBJWCANDACurrent
68391-500Berkley and Jensen Allergy ReliefCetirizine HydrochlorideBJWCANDACurrent
69256-458Harris Teeter All Day AllergyCetirizine HydrochlorideHarris Teeter, LLCANDACurrent
70000-0380leader all day allergyCetirizine HydrochlorideCardinal HealthANDACurrent
70000-0380leader all day allergyCetirizine HydrochlorideCardinal HealthANDACurrent
70000-0380leader all day allergyCetirizine HydrochlorideCardinal HealthANDACurrent
70000-0380leader all day allergyCetirizine HydrochlorideCardinal Health 110, LLC. dba LeaderANDACurrent
70518-1652CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1652CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1652CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1652CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1705CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1705CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1705CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1705CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1705CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2335CetirizineCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70677-0075Sunmark All Day AllergyCetirizine HydrochlorideStrategic Sourcing Services LLCANDACurrent
70677-0075Sunmark All Day AllergyCetirizine HydrochlorideStrategic Sourcing Services LLCANDACurrent
70925-001Humana Pharmacy All Day AllergyCetirizine HydrochlorideHumana Pharmacy, Inc.ANDACurrent
70925-001Humana Pharmacy All Day AllergyCetirizine HydrochlorideHumana Pharmacy, Inc.ANDACurrent
70934-986CetirizineCetirizine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71141-000Cetirizine HydrochlorideCetirizine HydrochlorideLidl US LLCANDACurrent
71141-000Cetirizine HydrochlorideCetirizine HydrochlorideLidl US LLCANDACurrent
71205-207cetirizine hydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-207cetirizine hydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-207cetirizine hydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-207cetirizine hydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-207cetirizine hydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-207cetirizine hydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71205-207cetirizine hydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
71610-123CetirizineCetirizine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-123CetirizineCetirizine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72288-411basic care all day allergyCetirizine HydrochlorideAmazon.com Services LLCANDACurrent
72288-411basic care all day allergyCetirizine HydrochlorideAmazon.com Services LLCANDACurrent
72288-411basic care all day allergyCetirizine HydrochlorideAmazon.com Services Inc.ANDACurrent
80159-101picnic antihistamineCetirizine Hydrochloride30M One, Inc.ANDACurrent
80267-401betr allergy reliefCetirizine HydrochlorideLive Betr LLCANDACurrent
80267-844Betr all day allergy reliefCetirizine HydrochlorideLive Betr LLCANDACurrent
81522-000caring mill all day allergyCetirizine HydrochlorideFSA Store Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9145ORIG2008-01-09
18480ORIG2008-01-08