Application 090760

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
004CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE 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
A090760-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2015-08-05
A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2015-08-05
A090760-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2015-08-05
A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2015-08-05

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05d06236e962d9…

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 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEKROGER COMPANYb92d959d-dd35-b2a3-e053-2995a90af3ff2026-07-15WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 30142-172
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCc1ae7bb1-e154-4745-b01e-bc91d50d35c82026-05-25WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.73122009-531b-4929-bf57-494a6fc65b732026-03-25WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutionsae02b16b-77dc-4bd6-8c07-e734fb4484922026-01-29WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutions158d3bcc-6a7f-4ee7-b181-be3fd6f94f8d2026-01-29WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBluePoint Laboratoriesa86fbe45-08db-bddf-e053-2a95a90aa7922025-10-30WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 68001-436
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE ALLERGYLEADER/ CARDINAL HEALTH 110, INC.0cab7aa8-ded3-46f1-b801-2663cc9b01732025-10-03WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 70000-0047
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEINNOVUS PHARMACEUTICALS, INC.89db2c96-62f6-4e75-8f0d-321b44094c602025-04-28WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2025-02-10WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 58602-447
ndc (product): 58602-813
ndc (product): 58602-446
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252024-09-13WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 58602-444
ndc (product): 58602-812
ndc (product): 58602-445
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutions42c9636f-07af-44a3-8d84-c11e1b57783a2024-07-02WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDENorthStar Rx LLCc9d1e26f-c95a-4991-95fa-9ed6ed484fe22024-06-26WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 16714-799
AMAZON BASIC CARE ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC113e66f1-b922-8533-e063-6294a90ab30e2024-05-10WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDECVS Pharmacy, Inc.e340cd4b-5413-42c6-a956-eb15c3807aeb2024-03-29WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 69842-237
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEProficient Rx LPd69083c4-b028-453c-8235-560b40ad358b2024-03-01WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC7d214cba-951d-464e-b37e-e83098944fe62024-01-11WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 58602-823
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.c0165b0e-d5e9-a028-e053-2a95a90ab4312023-05-25WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 0363-9602
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7e16d96-4f23-cbca-e053-6394a90aef4e2023-05-19WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9602Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
0363-9602Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
10202-715Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride7-ElevenANDACurrent
10202-715Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride7-ElevenANDACurrent
16714-799Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideNorthStar Rx LLCANDACurrent
16714-799Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideNorthStar Rx LLCANDACurrent
16714-799Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideNorthStar Rx LLCANDACurrent
30142-172Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideKROGER COMPANYANDACurrent
30142-172Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideKROGER COMPANYANDACurrent
55315-007Cetirizine Hydrochloride (Allergy Relief)Cetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-007Cetirizine Hydrochloride (Allergy Relief)Cetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-007Cetirizine Hydrochloride (Allergy Relief)Cetirizine HydrochlorideFred's, Inc.ANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-444Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-445Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-446Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-446Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-446Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-447Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-447Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-447Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-812Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-813Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-813Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-813Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-823Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-823Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-823Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
62011-0313all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0313all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0313all day allergyCetirizine HClMcKESSON CorporationANDACurrent
68001-436Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideBluePoint LaboratoriesANDACurrent
68001-436Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideBluePoint LaboratoriesANDACurrent
68071-2482Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
69842-237Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideCVS Pharmacy, Inc.ANDACurrent
70000-0047Cetirizine HydrochlorideCetirizine Hydrochloride AllergyCardinal HealthANDACurrent
70000-0047Cetirizine HydrochlorideCetirizine Hydrochloride AllergyCardinal HealthANDACurrent
70000-0047Cetirizine HydrochlorideCetirizine Hydrochloride AllergyCardinal HealthANDACurrent
70677-0006all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
70677-0006all day allergyCetirizine HClMcKESSON CorporationANDACurrent
70677-0006all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
80539-002Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAllwell Health IncANDACurrent