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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-273f01610625f2…
2019-12-14 00:12 UTC2019-12A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-273f01610625f2…
2019-12-14 00:12 UTC2019-12A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-273f01610625f2…
2019-12-14 00:12 UTC2019-12A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-273f01610625f2…
2019-09-15 20:21 UTC2019-09A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b00525d2431f…
2019-09-15 20:21 UTC2019-09A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b00525d2431f…
2019-09-15 20:21 UTC2019-09A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b00525d2431f…
2019-09-15 20:21 UTC2019-09A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A077499-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27ea99ee380514…
2019-07-19 19:46 UTC2019-07A077499-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27ea99ee380514…
2019-07-19 19:46 UTC2019-07A077499-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27ea99ee380514…
2019-07-19 19:46 UTC2019-07A077499-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27ea99ee380514…

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 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b6d0e4-8da5-9df5-e063-6294a90af3262026-10-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDELIDL US LLCe5fd935d-5b60-7270-e053-2995a90a71412026-09-09WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
all day allergyCETIRIZINE HYDROCHLORIDERite Aid Corporationbcbb9f5a-10b6-4a5e-a237-d29693d781032026-09-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLC17e93c22-1ff7-4af9-bd5a-448836aec65f2026-08-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCcd895177-3c25-4a1b-81a0-b85f4877787a2026-08-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrides Pharma, Inc.29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cf7672-fdde-ddbd-e063-6394a90a223b2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7e16d96-4f23-cbca-e053-6394a90aef4e2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
GOOD REMEDIES All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inc.44410d76-5940-4611-be45-579e2db8a65d2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cef432-41ac-768c-e063-6294a90a38fa2026-08-19WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
AMAZON BASICS ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC52163488-0b56-529d-e063-6294a90afc622026-08-17WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC0b0190c7-acfd-4140-bcaf-9fe835ebaf492026-07-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Incb9ac489a-80ed-4077-b68e-d03df1b892a62026-07-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
allergy reliefCETIRIZINE HYDROCHLORIDEH E B8649fc1e-ad56-4660-bbbb-8f1ed795697b2026-07-20WarningsName 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