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 11 of 14 · 267 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDEYYBA CORP0502f197-21e1-44f2-b621-c8df1ccd956e2024-01-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEDOLGENCORP, INC.0643ea78-9709-8526-e063-6394a90a227b2023-12-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsa6492645-8438-4e82-aa31-7e5b4bccb2202023-12-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLCc9eb5102-5514-4e69-8169-be7341e9fb662023-12-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7deb8ca-4a26-aece-e053-6294a90aa6852023-11-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerifoods Trading Companyf6ce3cdf-2e6d-61e8-e053-6294a90af7d32023-11-02WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEHARRIS TEETERb8f68d9d-2d3a-414a-e053-2a95a90a15ec2023-10-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEWALGREENSf3c66f47-016a-799a-e053-2995a90ad4242023-10-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutions84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a42023-09-14WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsf4da9adf-840d-4526-86a6-6666183fd1072023-07-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.c0165b0e-d5e9-a028-e053-2a95a90ab4312023-05-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIadcd0e8e-cca7-e1bb-e053-2995a90a83be2023-05-17WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
betr remedies all day allergy reliefCETIRIZINE HYDROCHLORIDELive Betr LLC4a017852-db01-4085-8947-d92a19ec4e5c2023-05-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Crcle Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEInnovus Pharmaceuticals, Inc.640583b6-379d-4ad3-b00c-383377c54eed2023-04-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEWINCO FOODS, LLCf45f5920-d82f-6549-e053-2995a90ad58a2023-04-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDENavajo Manufacturing Company Incorporated9c4693cb-f066-0666-e053-2a95a90a96d32023-03-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
topcare all day allergyCETIRIZINE HYDROCHLORIDETopco Associates LLC10c512a1-bb96-4d2a-9e41-a422efb57e282023-02-09WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
careone allergy reliefCETIRIZINE HYDROCHLORIDERetail Business Services, LLC6d94d302-b79a-4143-bb3c-c74da2a6a72e2022-10-20WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Welby Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAldi Inca8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a2022-10-13WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEMARC GLASSMAN, INC.951b6f19-15fe-45d7-e053-2995a90aa2542022-10-06WarningsName 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