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 44.

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-09-14 22:38:342026-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27caaa826d4ba7…
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…

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
CetirizineCETIRIZINE HYDROCHLORIDEA-S Medication Solutions88c3d23e-a0d8-4464-9414-666d74f11f662025-10-28WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
allergy reliefCETIRIZINE HYDROCHLORIDESafewayc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2025-09-23WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Equaline all day allergyCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI491fae66-83b6-4beb-945b-39b9e4e021c52025-09-18WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc0827643a-29b8-487a-a158-28976d672d4d2025-09-12WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company533abfc1-226e-4a68-bfcc-ec046a4d57512025-08-25WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
good neighbor pharmacy all day allergyCETIRIZINE HYDROCHLORIDEAmerisource Bergenc568e388-60ab-47be-b362-7832b83d06ad2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
leader all day allergyCETIRIZINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 70000-0380
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Inc2b03c026-3e8a-4283-981f-965bc084c03d2025-07-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
kirkland signature aller tec allergyCETIRIZINE HYDROCHLORIDECostco Wholesale Companyd4a688aa-02d4-4af6-9a91-ed31679cfaf82025-06-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 63981-458
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackae93976d-de9b-43a6-b299-ce1f1ae8d6f82025-05-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd91fe3ab8-c155-4482-9f06-f029d3563aad2025-03-06WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25db4ca0-0c25-f3b6-e063-6394a90a88512024-11-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Members Mark Allergy ReliefCETIRIZINE HYDROCHLORIDESam's West Inc379756fd-f92d-4773-94fd-2682fcbdfba22024-05-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.af7513ae-5107-477c-a7da-0ded9d53a55c2024-03-27WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
betr remedies all day allergy reliefCETIRIZINE HYDROCHLORIDELive Betr LLC4a017852-db01-4085-8947-d92a19ec4e5c2023-05-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

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 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