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 8 of 14 · 271 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company5cdd59a0-4d23-4f51-9aca-d66a639f84722025-04-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEINNOVUS PHARMACEUTICALS, INC.89db2c96-62f6-4e75-8f0d-321b44094c602025-04-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company2a62f905-663f-4aae-991f-a368b5120f6f2025-04-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLCa1edc2e6-3661-4d7a-884c-709d73cb89e02025-04-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC6a962a1c-c197-492b-bfa6-e0c28eda15332025-04-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEA-S Medication Solutions0adb3617-3528-4d64-a9ad-b4545ec9d7b92025-04-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLC013ce40e-37c9-4b84-b530-ed895f60ce0e2025-04-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cabinet All Day Allergy ReliefCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.889316bc-5f98-426a-9750-2fdb0c4274082025-04-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCe71e259a-494e-4a9a-b0e4-25bd25dd0e072025-04-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.3d2eac7f-db44-4771-8c7e-a38e68a7f24b2025-04-05WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f2025-04-03WarningsName fallback
brand name: cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEFSA STORE INC.ec6b4e86-ac27-e1f2-e053-2a95a90ab3e12025-03-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEUmasuto, LLC9af4ab23-d6d3-43f9-a026-76fd9771963f2025-03-06WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd91fe3ab8-c155-4482-9f06-f029d3563aad2025-03-06WarningsName fallback
brand name: cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ZYRTECCETIRIZINE HYDROCHLORIDEA-S Medication Solutions5c19a07e-09f4-46ed-939c-d21fe3e811f62025-03-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.a9b21d71-106e-4bd5-aaab-9254c8a44e0d2025-02-12Adverse reactionsName fallback
brand name: Cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
ValuMeds 24-Hour Allergy ReliefCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.fcb87d13-3385-4f4c-8d5e-6ba58e952e4e2025-01-27WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDERedPharm Drug Incf4c1f9fd-2d32-71d3-e053-2a95a90a3ba42025-01-23WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdc2cf555d-986c-4e89-ac4f-938e92c418e22025-01-20WarningsName fallback
brand name: cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
CABINET Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLCe49c3c91-aab8-478e-97fa-04ed061800212024-12-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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