FDA.reportPublic FDA data

Application 078615

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078615-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-28
A078615-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-28

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2884e616aacf4f…
2026-09-14 22:38:342026-08A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078615-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078615-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2874a2ff9319b5…

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 · 267 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be72024-05-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEOPMX LLCb452bca6-2c51-d0a1-e053-2995a90aff672024-05-17WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
AMAZON BASIC CARE ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC113e66f1-b922-8533-e063-6294a90ab30e2024-05-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Members Mark Allergy ReliefCETIRIZINE HYDROCHLORIDESam's West Inc379756fd-f92d-4773-94fd-2682fcbdfba22024-05-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy reliefCETIRIZINE HYDROCHLORIDESafewaycfc3daa5-7248-4105-95ee-4e19199655ce2024-04-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEWALGREEN CO.a9fd9b8f-509b-1ffa-e053-2a95a90a6d0f2024-04-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC15eaa0d1-d18d-72b1-e063-6394a90a8a942024-04-12WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDECVS Pharmacy, Inc.e340cd4b-5413-42c6-a956-eb15c3807aeb2024-03-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDECamber Consumer Care Inc941e4aa9-6388-424c-87ad-3ea2ec5aafea2024-03-27WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.af7513ae-5107-477c-a7da-0ded9d53a55c2024-03-27WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutionse626bd59-dd18-465c-b740-9d04eb48c28e2024-03-14Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride Tablets,10 mgCETIRIZINE HYDROCHLORIDETIME CAP LABORATORIES, INC.d78223ba-80d5-47f8-e053-2a95a90aebdb2024-03-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEProficient Rx LPd69083c4-b028-453c-8235-560b40ad358b2024-03-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.6493d4f6-dead-45ec-ade1-28ce624af33d2024-02-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEA-S Medication Solutions016b66fd-dde9-4f13-afaf-a8aafbdeed1a2024-01-23WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDESDA Laboratories, Inc.222a7e77-33a6-44ca-9ab1-0bc4fc431aa32024-01-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC7d214cba-951d-464e-b37e-e83098944fe62024-01-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDETWIN MED, LLCd9437d88-da59-5567-e053-2995a90a362b2024-01-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31377ORIG2008-01-09
18485ORIG2008-01-08