FDA.reportPublic FDA data

Application 077279

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077279-001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27c2088c7a36db…
2026-09-14 22:38:342026-08A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-2784e616aacf4f…
2026-08-18 06:07:402026-07A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-273f01610625f2…
2019-09-15 20:21 UTC2019-09A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2008-05-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077279-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAA2008-05-273a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077279-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077279-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077279-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077279-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077279-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077279-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077279-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A077279-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077279-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077279-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077279-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A077279-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077279-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077279-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077279-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077279-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077279-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077279-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077279-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077279-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077279-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077279-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077279-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077279-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077279-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077279-001AA1cb3db0bc1861…

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 · 271 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
brand name: CETIRIZINE HYDROCHLORIDE
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
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSPreferred Pharmaceuticals Inc.14a885e5-5e75-4a18-b5bc-6aaa748712db2026-03-25WarningsName fallback
brand 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
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBryant Ranch Prepack9c11dd22-cb17-4179-8c54-1d515bf662d22026-03-20WarningsName fallback
brand name: CETIRIZINE HYDROCHLORIDE
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a7da81e1-8865-45c9-83c7-32fb8032ca2e2026-03-19WarningsName fallback
brand name: Cetirizine Hydrochloride
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
brand name: Cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
QUZYTTIRCETIRIZINE HYDROCHLORIDETerSera Therapeutics LLCf33e859d-ebc9-4d4f-a57d-204c48760d202026-03-04Warnings, Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSProficient Rx LP55b1738c-fa72-4cd1-a8e8-be41b12b593d2026-03-01WarningsName fallback
brand name: Cetirizine Hydrochloride
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCffbca2a4-8df0-4c85-adf9-9414cd706fb22026-02-26WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
BERKLEY AND JENSEN ALL DAY ALLERGYCETIRIZINE HYDROCHLORIDEBJWCb38c0068-5b06-4976-b68d-617bcc14f0512026-02-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESportpharm LLCdd50d2e9-3de7-4c44-96ed-39ef04dae7022026-02-06WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSSportpharm LLCd5297bdb-823c-4318-a797-5311d5cf0df82026-02-06WarningsName fallback
brand name: Cetirizine Hydrochloride
CHILDRENS CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEWALMART INC.473ad691-2499-a706-e063-6394a90a97812026-01-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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