FDA.reportPublic FDA data

Application 209274

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209274-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2017-12-22

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22a50c72e98297…

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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HYDROCHLORIDELIDL US LLCe5fd935d-5b60-7270-e053-2995a90a71412026-09-09WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
MedlineCETIRIZINE HCLMedline Industries, LPa75cd557-e19b-fdd4-e053-2a95a90a80972026-06-04WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (product): 53329-033
Allergy ReliefCETIRIZINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.ac22558b-5c82-4ab9-95b8-53eedea462822026-05-28WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (product): 57344-194
Allergy ReliefCETIRIZINE HYDROCHLORIDEGrocery Outlet, Inc441d049c-8844-955e-e063-6294a90a666d2026-05-21WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDETWIN MED, LLC14317ee7-1061-4c2b-9427-3433e27f13f52026-04-01WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLBryant Ranch Prepack7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea2026-03-10WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLCc5dab2f3-8f95-4b85-995b-23b21c762ae82026-02-23WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (product): 59726-806
All Day Allergy ReliefCETIRIZINE HCLStrategic Sourcing Services LLC2965303e-bedc-41fb-af97-827c305750912026-01-05WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEGranules USA, Inc.c8d711cd-7214-c7d5-e053-2995a90a6b672025-12-22WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (product): 69848-006
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERETAIL BUSINESS SERVICES,LLC.9f04520e-161d-3f7b-e053-2a95a90a678d2025-12-19WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HCLCETIRIZINE HCLMeijer181c63dd-6ab8-909a-e063-6394a90af1412025-12-19WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CetirizineCETIIRIZINECVS PHARMACY, INCfd8f495a-9940-363b-e053-6294a90a10972025-12-19WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESAFEWAYed0eecfb-85bf-63bf-e053-2995a90a0e032025-12-18WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYdc66bf53-820f-40a3-b5ef-c653dd3755442025-12-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (product): 63941-194
CAREALL Allergy ReliefCETIRIZINE HCLNew World Importsd3411eec-05b1-49b3-86e8-bc47ac0ef6b72025-12-01WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLFamily Dollar (FAMILY WELLNESS)b90b5ef2-5aa2-45ca-94b9-c9d9e5877e232025-09-25WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Wal-ZyrCETIRIZINE HCLWalgreensf0d3f681-92c4-45d4-9533-656c9e5e23662025-07-02WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (product): 0363-0606
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvanced Rx LLC737492bf-96bd-4f7c-aa42-4910746f44bb2025-05-13WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLCamber Consumer Care91cb9fe1-9c52-4c37-9751-3669207c66762025-03-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (product): 69230-304

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 2 · 102 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0606Wal-ZyrCetirizine HClWalgreensANDACurrent
0363-0606Allergy ReliefCetirizine HClWalgreensANDACurrent
0363-0606Wal-ZyrCetirizine HClWalgreensANDACurrent
0363-0606Wal-ZyrCetirizine HClWalgreensANDACurrent
0363-0606Wal-ZyrCetirizine HClWalgreensANDACurrent
0363-9899Cetirizine HydrochlorideCetirizine HydrochlorideWALGREEN CO.ANDACurrent
0363-9899Cetirizine HydrochlorideCetirizine HydrochlorideWALGREEN CO.ANDACurrent
0363-9899Cetirizine HydrochlorideCetirizine HydrochlorideWALGREEN CO.ANDACurrent
41163-197Allergy ReliefCetirizine hydrochlorideUNFIANDACurrent
47682-204Medique CetiramedCetirizine HClUnifirst First Aid CorporationANDACurrent
47682-204Medique CetiramedCetirizine HClUnifirst First Aid CorporationANDACurrent
47682-204Medique CetiramedCetirizine HClUnifirst First Aid CorporationANDACurrent
50066-396Allergy ReliefCetirizine HCl 10 mgGenomma Labs USA, IncANDACurrent
50066-396Allergy ReliefCetirizine HCl 10 mgGenomma Labs USA, IncANDACurrent
50090-3906Allergy ReliefCetirizine HClA-S Medication SolutionsANDACurrent
50090-3906Allergy ReliefCetirizine HClA-S Medication SolutionsANDACurrent
50090-3906Allergy ReliefCetirizine HClA-S Medication SolutionsANDACurrent
51824-076CAREALL Cetirizine HClCetirizineNew World ImportsANDACurrent
51824-076CAREALL Cetirizine HClCetirizineNew World ImportsANDACurrent
53329-033Medlinecetirizine hclMedline Industries, Inc.ANDACurrent
53329-033Medlinecetirizine hclMedline Industries, Inc.ANDACurrent
53329-033Medlinecetirizine hclMedline Industries, Inc.ANDACurrent
53329-033Medlinecetirizine hclMedline Industries, LPANDACurrent
53329-033Medlinecetirizine hclMedline Industries, LPANDACurrent
53943-194ALLERGY RELIEFCetirizine hydrochlorideDISCOUNT DRUG MARTANDACurrent
54257-270Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-270Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-270Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
55315-806Allergy ReliefCetirizine HClFreds IncANDACurrent
55315-806Allergy ReliefCetirizine HClFreds IncANDACurrent
55315-806Allergy ReliefCetirizine HClFreds IncANDACurrent
55681-302CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDETWIN MED, LLCANDACurrent
55681-302CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDETWIN MED, LLCANDACurrent
57344-194Allergy ReliefCetirizine hydrochlorideAAA PHARMACEUTICAL, INC.ANDACurrent
57344-194Allergy ReliefCetirizine hydrochlorideAAA PHARMACEUTICAL, INC.ANDACurrent
59726-806All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-806All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-806All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
62011-0384All Day Allergy ReliefCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0384All Day Allergy ReliefCetirizine HClMcKesson (Health Mart)ANDACurrent
62011-0384All Day Allergy ReliefCetirizine HClStrategic Sourcing Services LLCANDACurrent
62207-764Cetirizine hydrochlorideCetirizine hydrochlorideGranules India LtdANDACurrent
62207-764Cetirizine hydrochlorideCetirizine hydrochlorideGranules India LtdANDACurrent
62207-764Cetirizine hydrochlorideCetirizine hydrochlorideGranules India LtdANDACurrent
62207-764Cetirizine hydrochlorideCetirizine hydrochlorideGranules India LtdANDACurrent
63868-665Allergy ReliefCetirizine hydrochlorideCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63868-665Allergy ReliefCetirizine hydrochlorideCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63941-194Allergy ReliefCetirizine hydrochlorideVALU MERCHANDISERS COMPANYANDACurrent
66424-564CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDESDA Laboratories, Inc.ANDACurrent
66715-695024 Hour AllergyCetirizine hydrochlorideLil' Drug Store Products, Inc.ANDACurrent
66715-695024 Hour AllergyCetirizine hydrochlorideLil' Drug Store Products, Inc.ANDACurrent
66715-695024 Hour AllergyCetirizine hydrochlorideLil' Drug Store Products, Inc.ANDACurrent
67091-351Allergy ReliefCetirizine HClWinCo Foods, LLCANDACurrent
67091-351Allergy ReliefCetirizine HClWinCo Foods, LLCANDACurrent
68016-294Allergy ReliefCetirizine hydrochlorideCHAIN DRUG CONSORTIUMANDACurrent
68210-0119Cabinet Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-0119CABINET Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-0119CABINET Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-0119CABINET Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4219Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68210-4230Allergy ReliefCetirizine HydrochlorideSpirit Pharmaceutical LLCANDACurrent
68998-194Allergy ReliefCetirizine hydrochlorideMARC GLASSMAN, INC.ANDACurrent
68998-194Allergy ReliefCetirizine hydrochlorideMARC GLASSMAN, INC.ANDACurrent
69168-396Allergy ReliefCetirizine HCl 10 mgAllegiant HealthANDACurrent
69168-396Allergy ReliefCetirizine HCl 10 mgAllegiant HealthANDACurrent
69230-304Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-304Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-304Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-304Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-304Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-304Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-304Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69729-139Cetirizine hydrochlorideCetirizine hydrochlorideOPMX LLCANDACurrent
69729-139Cetirizine hydrochlorideCetirizine hydrochlorideOPMX LLCANDACurrent
69848-006Cetirizine HydrochlorideCetirizine HydrochlorideGranules USA, Inc.ANDACurrent
70010-163Cetirizine hydrochlorideCetirizine hydrochlorideGranules Pharmaceuticals Inc.ANDACurrent
70010-163Cetirizine hydrochlorideCetirizine hydrochlorideGranules Pharmaceuticals Inc.ANDACurrent
70010-163Cetirizine hydrochlorideCetirizine hydrochlorideGranules Pharmaceuticals Inc.ANDACurrent
70518-2731Allergy ReliefCETIRIZINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2731Allergy ReliefCETIRIZINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent