FDA.reportPublic FDA data

Application 077499

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077499-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A077499-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A077499-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A077499-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

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 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-09-14 22:38:342026-08A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-272680178bc6a6…

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 7 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inca814a06b-96ed-4403-bbd7-fc1142988b502025-06-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inc817d07cf-5e31-421f-9e95-943bae01f5b02025-06-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEBETTER LIVING BRANDS, LLCeb60ae7d-87db-7413-e053-2a95a90afd762025-06-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEMorning Star OTC3efa421d-ea70-4b1f-95d0-7c63b6c395802025-06-19WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC HivesCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31136e3a-94fa-0860-e063-6394a90a008d2025-06-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC HIVESCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31400cb2-fe85-ef74-e063-6294a90a11fb2025-06-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
kirkland signature aller tec allergyCETIRIZINE HYDROCHLORIDECostco Wholesale Companyd4a688aa-02d4-4af6-9a91-ed31679cfaf82025-06-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackae93976d-de9b-43a6-b299-ce1f1ae8d6f82025-05-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvanced Rx LLC737492bf-96bd-4f7c-aa42-4910746f44bb2025-05-13WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
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
generic name: CETIRIZINE HYDROCHLORIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57664-540Cetirizine HydrochlorideCetirizine HydrochlorideCaraco Pharmaceutical Laboratories, Ltd.ANDACurrent
57664-541Cetirizine HydrochlorideCetirizine HydrochlorideCaraco Pharmaceutical Laboratories, Ltd.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31252ORIG2008-01-09
39534ORIG2008-01-08