Home Applications 078933 Application 078933
Type ANDA
Sponsor MARKSANS PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE TABLET;ORAL 5MG No No 002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE TABLET;ORAL 10MG No No 003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE TABLET;ORAL 5MG No No 004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-06-15 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-06-15 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-06-15 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-06-15
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 3 of 5 · 176 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 2019-12-13 00:20 UTC 2019-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 ea99ee380514…
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 1 of 1 · 8 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) CETIRIZINE HYDROCHLORIDE MARKSANS PHARMA LIMITED 652b0c65-a3f2-4454-9cf2-51a3389282cc 2026-07-10 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (product): 25000-220 ndc (product): 25000-219 Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE Northwind Health Company, LLC f756d3b1-d2e4-3705-e053-6294a90aa380 2026-01-01 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ALLERGY CETIRIZINE HYDROCHLORIDE Kroger Company bc020340-ef39-e49a-e053-2a95a90af810 2025-09-11 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (product): 41226-692 Allergy Relief CETIRIZINE HYDROCHLORIDE BETTER LIVING BRANDS, LLC eb60ae7d-87db-7413-e053-2a95a90afd76 2025-06-28 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. d78223ba-80d5-47f8-e053-2a95a90aebdb 2024-03-06 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (product): 49483-692 All Day Allergy Relief CETIRIZINE HYDROCHLORIDE DOLGENCORP, INC. 0643ea78-9709-8526-e063-6394a90a227b 2023-12-15 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Allergy Relief CETIRIZINE HYDROCHLORIDE WALGREENS f3c66f47-016a-799a-e053-2995a90ad424 2023-10-21 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. dfbddafb-9455-5805-e053-2a95a90ad0d9 2022-05-24 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (product): 49483-682
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25000-219 Cetirizine Hydrochloride Tablets, 5 mg Cetirizine Hydrochloride MARKSANS PHARMA LIMITED ANDA Current 25000-220 Cetirizine Hydrochloride Tablets, 10 mg Cetirizine Hydrochloride MARKSANS PHARMA LIMITED ANDA Current 41226-692 ALLERGY CETIRIZINE HYDROCHLORIDE Kroger Company ANDA Current 41226-692 ALLERGY CETIRIZINE HYDROCHLORIDE Kroger Company ANDA Current 49483-682 Cetirizine Hydrochloride Cetirizine Hydrochloride TIME CAP LABORATORIES, INC. ANDA Current 49483-692 Cetirizine Hydrochloride Tablets,10 mg Cetirizine Hydrochloride TIME CAP LABORATORIES, INC. ANDA Current 49483-692 Cetirizine Hydrochloride Tablets,10 mg Cetirizine Hydrochloride TIME CAP LABORATORIES, INC. ANDA Current 49483-692 Cetirizine Hydrochloride Tablets,10 mg Cetirizine Hydrochloride TIME CAP LABORATORIES, INC. ANDA Current