FDA.reportPublic FDA data

Application 078933

Type
ANDA
Sponsor
MARKSANS PHARMA

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
A078933-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15
A078933-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15

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 UTC2026-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15d06236e962d9…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)CETIRIZINE HYDROCHLORIDEMARKSANS PHARMA LIMITED652b0c65-a3f2-4454-9cf2-51a3389282cc2026-07-10WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
ndc (product): 25000-220
ndc (product): 25000-219
Cetirizine Hydrochloride Tablets,10 mgCETIRIZINE HYDROCHLORIDENorthwind Health Company, LLCf756d3b1-d2e4-3705-e053-6294a90aa3802026-01-01WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
ALLERGYCETIRIZINE HYDROCHLORIDEKroger Companybc020340-ef39-e49a-e053-2a95a90af8102025-09-11WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
ndc (product): 41226-692
Allergy ReliefCETIRIZINE HYDROCHLORIDEBETTER LIVING BRANDS, LLCeb60ae7d-87db-7413-e053-2a95a90afd762025-06-28WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
Cetirizine Hydrochloride Tablets,10 mgCETIRIZINE HYDROCHLORIDETIME CAP LABORATORIES, INC.d78223ba-80d5-47f8-e053-2a95a90aebdb2024-03-06WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
ndc (product): 49483-692
All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEDOLGENCORP, INC.0643ea78-9709-8526-e063-6394a90a227b2023-12-15WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
Allergy ReliefCETIRIZINE HYDROCHLORIDEWALGREENSf3c66f47-016a-799a-e053-2995a90ad4242023-10-21WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDETIME CAP LABORATORIES, INC.dfbddafb-9455-5805-e053-2a95a90ad0d92022-05-24WarningsExact identifier
application applno (ANDA): 078933
application number: ANDA078933
ndc (product): 49483-682

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25000-219Cetirizine Hydrochloride Tablets, 5 mgCetirizine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-220Cetirizine Hydrochloride Tablets, 10 mgCetirizine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
41226-692ALLERGYCETIRIZINE HYDROCHLORIDEKroger CompanyANDACurrent
41226-692ALLERGYCETIRIZINE HYDROCHLORIDEKroger CompanyANDACurrent
49483-682Cetirizine HydrochlorideCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-692Cetirizine Hydrochloride Tablets,10 mgCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-692Cetirizine Hydrochloride Tablets,10 mgCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-692Cetirizine Hydrochloride Tablets,10 mgCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent