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 4 of 14 · 271 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetirizine Hydrochloride (Allergy) CETIRIZINE HYDROCHLORIDE A-S Medication Solutions ae02b16b-77dc-4bd6-8c07-e734fb448492 2026-01-29 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride (Allergy) CETIRIZINE HYDROCHLORIDE A-S Medication Solutions 158d3bcc-6a7f-4ee7-b181-be3fd6f94f8d 2026-01-29 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Allergy Relief CETIRIZINE HYDROCHLORIDE Strategic Sourcing Services LLC 54509525-ad99-4165-a571-47ece058e292 2026-01-29 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine CETIRIZINE HYDROCHLORIDE Major Pharmaceuticals a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3 2026-01-29 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE Preferred Pharmaceuticals Inc. a462f9c0-45ef-49b1-b0d8-a02a75a4b731 2026-01-27 Warnings Name fallback brand name: cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Allergy Relief CETIRIZINE HYDROCHLORIDE Prodose, Inc e0e5f482-0282-410c-8c40-0a33ca4ea23a 2026-01-26 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Childrens Zyrtec Allergy CETIRIZINE HYDROCHLORIDE Kenvue Brands LLC ee8695ac-1293-4e43-ac7c-a64e21a0ca0a 2026-01-19 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Exchange select all day allergy CETIRIZINE HYDROCHLORIDE Army & Air Force Exchange Service e7220494-3640-4b33-b577-ed3ca7c483e8 2026-01-15 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE Rising Pharma Holdings, Inc. efabbad5-a162-45c8-a896-5af58e5d2d39 2026-01-13 Adverse reactions Name fallback brand name: CETIRIZINE HYDROCHLORIDE generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE WALGREEN CO. 9e728bf2-0cb9-ecf5-e053-2a95a90a408a 2026-01-08 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Good Sense all day allergy CETIRIZINE HYDROCHLORIDE L. Perrigo Company 2a7a27ab-1b4c-40d1-98bf-e4297aa25682 2026-01-08 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine CETIRIZINE HYDROCHLORIDE Northwind Health Company, LLC f2b4d221-30ae-5a43-e053-2995a90a238a 2026-01-01 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE TABLETS Northwind Health Company, LLC f70886af-a8a4-63a0-e053-6294a90a2d2c 2026-01-01 Warnings Name fallback brand name: Cetirizine Hydrochloride Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE Northwind Health Company, LLC f756d3b1-d2e4-3705-e053-6294a90aa380 2026-01-01 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE QUAGEN PHARMACEUTICALS LLC 9163cd2e-0be7-4009-b905-729014773d6e 2025-12-26 Warnings Name fallback brand name: CETIRIZINE HYDROCHLORIDE generic name: CETIRIZINE HYDROCHLORIDE TopCare All Day Allergy CETIRIZINE HYDROCHLORIDE Topco Associates LLC f2919aad-9ed4-40b8-b233-4aec06df33ea 2025-12-23 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Granules USA, Inc. c8d711cd-7214-c7d5-e053-2995a90a6b67 2025-12-22 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE RETAIL BUSINESS SERVICES,LLC. 9f04520e-161d-3f7b-e053-2a95a90a678d 2025-12-19 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE Up and Up Allergy Relief CETIRIZINE HYDROCHLORIDE Target Corporation ce93ca5b-2a65-4873-9686-926c44076c6c 2025-12-19 Warnings Name fallback generic name: CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE SAFEWAY ed0eecfb-85bf-63bf-e053-2995a90a0e03 2025-12-18 Warnings Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.