FDA.reportPublic FDA data

Application 078615

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078615-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-28
A078615-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-28

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2884e616aacf4f…
2026-09-14 22:38:342026-08A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2874a2ff9319b5…

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 3 of 14 · 267 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECVS Pharmacy, Inc.b45c95f2-91c9-55b5-e053-2995a90a75b72026-05-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECVS Pharmacy, Inc.b955c7ed-29da-959f-e053-2a95a90a03d42026-05-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CetirizineCETIRIZINE HYDROCHLORIDEMajor Pharmaceuticals71db132d-dca4-47ef-8560-c68ad22589332026-05-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESafecor Health, LLC734118ec-bf9a-4e58-b728-50b6c832b2702026-05-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLCdc613bd5-70fd-1d9b-e053-2995a90a41cd2026-04-27WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLC0fe77356-d945-46a0-882e-b3bbab7845562026-04-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
All Day AllergyCETIRIZINE HYDROCHLORIDEHyVee Inc8889af37-8345-4358-994d-7d8b847f48742026-04-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CetirizineCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC37c6d1e4-dd88-42a2-a828-539b68aa5dad2026-04-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Goodmeds All Day Allergy Relief Cetirizine HClCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.cd13a70e-b9e2-41be-97ea-f022442b64602026-04-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDETWIN MED, LLC14317ee7-1061-4c2b-9427-3433e27f13f52026-04-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief Indoor and Outdoor AllergiesCETIRIZINE HYDROCHLORIDECVS Pharmacy98f3f2c6-da18-4055-81f1-962261360f9b2026-03-31WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e874264a-becc-45d0-b934-779eab5f50852026-03-25Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.73122009-531b-4929-bf57-494a6fc65b732026-03-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.7e94be37-0971-44b3-9857-f56330d810b62026-03-25Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBryant Ranch Prepack9c11dd22-cb17-4179-8c54-1d515bf662d22026-03-20WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a7da81e1-8865-45c9-83c7-32fb8032ca2e2026-03-19WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CetirizineCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack7e158fd6-268d-4ffc-a410-d054090d54c52026-03-19WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvagen Pharma Ltd.,0956baea-f0ad-4aac-9464-831840db92302026-03-06Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
QUZYTTIRCETIRIZINE HYDROCHLORIDETerSera Therapeutics LLCf33e859d-ebc9-4d4f-a57d-204c48760d202026-03-04Warnings, Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCffbca2a4-8df0-4c85-adf9-9414cd706fb22026-02-26WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31377ORIG2008-01-09
18485ORIG2008-01-08