FDA.reportPublic FDA data

Application 077498

Type
ANDA
Sponsor
SUN PHARM INDS LTD

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 1.

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
A077498-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A077498-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A077498-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A077498-004CETIRIZINE 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077498-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27a50c72e98297…
2026-08-01 22:54:322026-06A077498-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27a50c72e98297…
2026-08-01 22:54:322026-06A077498-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27a50c72e98297…
2026-08-01 22:54:322026-06A077498-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESportpharm LLC357523b6-618b-4bff-a80d-c62e72a0804e2026-05-08WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a7da81e1-8865-45c9-83c7-32fb8032ca2e2026-03-19WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 55289-995
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inceb917099-fecf-6b55-e053-2995a90aaafa2025-09-23WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 10135-762
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-9001-8776-e053-2a95a90ae6512024-08-12WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 68071-2571
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC15eaa0d1-d18d-72b1-e063-6394a90a8a942024-04-12WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LPd14feb90-3ca2-4d5b-825c-25fc2252ca382022-06-01WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 63187-110
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEOhm Laboratories Inc.161c4122-2c89-46e6-a6ae-db088087330d2021-05-21WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 51660-939
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPublix Super Markets Inca0a063a1-e067-480e-afab-7f01165025f42019-08-19WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 56062-939
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Consortium, LLC9d7d2342-a594-4851-810b-b7bce1bd07dc2018-08-24WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 68016-939
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEValu Merchandisers Company4a8d2887-8ac3-4d54-9e67-4a271d4164262018-08-23WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 63941-939
Quality Choice Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Marketing Association Inc.2e8cc4e3-8386-42de-801f-fef37f6128492018-08-22WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 63868-132
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMarc Glassman, Inc.f30900e6-425f-43e0-81b6-1fa3bd321f0b2018-06-20WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 68998-939
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US, LLCa210d6b7-0829-4120-bb6d-fee0c2e57b262018-01-09WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 71141-133
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEFAMILY DOLLAR SERVICES, INCb326dacc-6123-47a7-9fde-6909db1d780b2018-01-08WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
ndc (product): 55319-939

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6100Cetirizine hydrochlorideCetirizine hydrochlorideMajor PharmaceuticalsANDACurrent
10135-762Cetirizine HydrochlorideCetirizine HydrochlorideMarlex Pharmaceuticals, IncANDACurrent
10135-762Cetirizine HydrochlorideCetirizine HydrochlorideMarlex Pharmaceuticals, IncANDACurrent
10202-939Cetirizine HydrochlorideCetirizine Hydrochloride7-ELEVENANDACurrent
15127-909Cetirizine HydrochlorideCetirizine HydrochlorideSelect BrandANDACurrent
36800-244Cetirizine HydrochlorideCetirizine HydrochlorideTopco Associates LLCANDACurrent
37012-939Cetirizine HydrochlorideCetirizineShopko Stores Operating Co., LLCANDACurrent
37205-820LEADER ALL DAY ALLERGYcetirizineCardinal HealthANDACurrent
42254-138Cetirizine hydrochlorideCetirizine hydrochlorideRebel Distributors CorpANDACurrent
49348-389Cetirizine HydrochlorideCetirizine HydrochlorideSunmarkANDACurrent
50090-5518Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5518Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
51660-939Cetirizine HydrochlorideCetirizine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-939Cetirizine HydrochlorideCetirizine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-939Cetirizine HydrochlorideCetirizine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-939Cetirizine HydrochlorideCetirizine HydrochlorideOhm Laboratories Inc.ANDACurrent
53329-652Cetirizine HydrochlorideCetirizine HydrochlorideMedline Industries, Inc.ANDACurrent
53329-652Cetirizine HydrochlorideCetirizine HydrochlorideMedline Industries, Inc.ANDACurrent
53329-652Cetirizine HydrochlorideCetirizine HydrochlorideMedline Industries, Inc.ANDACurrent
53329-652Cetirizine HydrochlorideCetirizine HydrochlorideMedline Industries, Inc.ANDACurrent
53329-652Cetirizine HydrochlorideCetirizine HydrochlorideMedline Industries, LPANDACurrent
53329-652Cetirizine HydrochlorideCetirizine HydrochlorideMedline Industries, LPANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-995Cetirizine HydrochlorideCetirizine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55301-939Cetirizine HydrochlorideCetirizine HydrochlorideArmy & Air Force Exchange ServiceANDACurrent
55319-939Cetirizine HydrochlorideCetirizine HydrochlorideFAMILY DOLLAR SERVICES, INCANDACurrent
56062-939Cetirizine HydrochlorideCetirizine HydrochloridePublix Super Markets IncANDACurrent
56062-939Cetirizine HydrochlorideCetirizine HydrochloridePublix Super Markets IncANDACurrent
57451-5067Cetirizine HydrochlorideCetirizine HydrochlorideIpca Laboratories LimitedANDACurrent
58593-827Zero AllergyCetirizine HydrochlorideEfficient Laboratories IncANDACurrent
58593-827Zero AllergyCetirizine HydrochlorideEfficient Laboratories IncANDACurrent
59779-939Cetirizine HydrochlorideCetirizine HydrochlorideCVS PharmacyANDACurrent
61715-062Cetirizine HydrochlorideCetirizine HydrochlorideKinrayANDACurrent
63187-110Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63187-110Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63187-110Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63187-110Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63868-132Quality Choice Cetirizine HydrochlorideCetirizine HydrochlorideChain Drug Marketing Association Inc.ANDACurrent
63941-939Cetirizine HydrochlorideCetirizine HydrochlorideValu Merchandisers CompanyANDACurrent
67091-247Cetirizine HydrochlorideCetirizine HydrochlorideWinCo Foods, LLCANDACurrent
68016-939Cetirizine HydrochlorideCetirizine HydrochlorideChain Drug Consortium, LLCANDACurrent
68071-2571Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68998-939Cetirizine HydrochlorideCetirizine HydrochlorideMarc Glassman, Inc.ANDACurrent
71141-133Cetirizine HydrochlorideCetirizine HydrochlorideLIDL US, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31251ORIG2008-01-09
39533ORIG2008-01-08