Home Applications 077279 Application 077279
Type ANDA
Sponsor TEVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SYRUP;ORAL 5MG/5ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077279-001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077279-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-05-27 3a93d1ddd44b…
Observed Orange Book normalized TE history# 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 10 of 14 · 271 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE NCS HealthCare of KY, LLC dba Vangard Labs b53d5e8a-a30c-4025-aa72-d2776a112e3e 2024-06-24 Warnings Name fallback brand name: Cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE SIMPLY RIGHT childrens cetirizine CETIRIZINE HYDROCHLORIDE Sam's West Inc 48b47541-cf0c-48a7-9a65-2158fd1284f1 2024-06-24 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE PAI Holdings, LLC dba PAI Pharma 71448ab0-e23e-4cf7-940e-7d67e7362fb4 2024-06-19 Adverse reactions Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE TOPCO ASSOCIATES LLC f4ba3e0c-e6b3-2596-e053-2a95a90ab850 2024-06-11 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE up and up childrens allergy CETIRIZINE HYDROCHLORIDE Target Corporation 4b1ee9b1-d22e-4fb2-8dcd-912374da12d7 2024-06-06 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE up and up childrens allergy CETIRIZINE HYDROCHLORIDE Target Corporation 1f37c327-cd4c-4bc1-ae70-713569694e2e 2024-06-04 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Bryant Ranch Prepack ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7 2024-05-21 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE OPMX LLC b452bca6-2c51-d0a1-e053-2995a90aff67 2024-05-17 Warnings Name fallback brand name: Cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Members Mark Allergy Relief CETIRIZINE HYDROCHLORIDE Sam's West Inc 379756fd-f92d-4773-94fd-2682fcbdfba2 2024-05-10 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE childrens allergy relief CETIRIZINE HYDROCHLORIDE Safeway cfc3daa5-7248-4105-95ee-4e19199655ce 2024-04-30 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Childrens Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE WALGREEN CO. a9fd9b8f-509b-1ffa-e053-2a95a90a6d0f 2024-04-15 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 15eaa0d1-d18d-72b1-e063-6394a90a8a94 2024-04-12 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride (Allergy) CETIRIZINE HYDROCHLORIDE CVS Pharmacy, Inc. e340cd4b-5413-42c6-a956-eb15c3807aeb 2024-03-29 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE CHILDRENS ALLERGY RELIEF CETIRIZINE HYDROCHLORIDE Camber Consumer Care Inc 941e4aa9-6388-424c-87ad-3ea2ec5aafea 2024-03-27 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. af7513ae-5107-477c-a7da-0ded9d53a55c 2024-03-27 Warnings Name fallback brand name: cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE A-S Medication Solutions e626bd59-dd18-465c-b740-9d04eb48c28e 2024-03-14 Adverse reactions Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. d78223ba-80d5-47f8-e053-2a95a90aebdb 2024-03-06 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride (Allergy) CETIRIZINE HYDROCHLORIDE Proficient Rx LP d69083c4-b028-453c-8235-560b40ad358b 2024-03-01 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Rising Pharma Holdings, Inc. 6493d4f6-dead-45ec-ade1-28ce624af33d 2024-02-22 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Good Sense all day allergy CETIRIZINE HYDROCHLORIDE A-S Medication Solutions 2f562a13-8909-4107-b135-10333707bab3 2024-01-24 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.