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 12 of 14 · 271 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare all day allergyCETIRIZINE HYDROCHLORIDETopco Associates LLC10c512a1-bb96-4d2a-9e41-a422efb57e282023-02-09WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
careone allergy reliefCETIRIZINE HYDROCHLORIDERetail Business Services, LLC6d94d302-b79a-4143-bb3c-c74da2a6a72e2022-10-20WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Welby Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAldi Inca8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a2022-10-13WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEMARC GLASSMAN, INC.951b6f19-15fe-45d7-e053-2995a90aa2542022-10-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEProficient Rx LP582db483-394e-4c00-8522-4041a11696e42022-10-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Good Sense All Day AllergyCETIRIZINE HYDROCHLORIDEL. Perrigo Company5b1203c7-9678-4cee-9d7b-6510da2955612022-09-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC1bbefda2-d3c5-4d31-b3ec-7da077e411572022-08-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEStrategic Sourcing Services1dd63ede-37ca-4b5a-bfed-1aca5dd154242022-07-27WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDERITE AID CORPORATIONde169567-5cde-5c4a-e053-2a95a90a12152022-07-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LPd14feb90-3ca2-4d5b-825c-25fc2252ca382022-06-01WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDETIME CAP LABORATORIES, INC.dfbddafb-9455-5805-e053-2a95a90ad0d92022-05-24WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LP198ca875-bb8a-49d5-8809-7121ba1193812022-04-01WarningsName fallback
brand name: cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Inc6baa66e7-93df-43d9-a301-5d9c14274c992022-04-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
allergy reliefCETIRIZINE HYDROCHLORIDEPublix Super Markets Inc268170c9-b6a7-4851-b7d3-33dd1d733e392022-03-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMylan Pharmaceuticals Inc.487ae0f0-320c-4534-b9e2-0e215f167cea2022-01-12WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCc3e987c5-7ca1-4514-aa0a-6668ff2937c52022-01-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.f0a3e654-5fec-4f98-84da-4c30500633b42021-10-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company833e8904-d37d-4478-af7c-8287f2d079a72021-08-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ALLERGY RELIEFCETIRIZINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.95bf367c-eea8-73f9-e053-2a95a90a3dea2021-07-12WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp, LLCba7d3995-c992-457c-a628-f036d77cc6382021-06-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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