FDA.reportPublic FDA data

Application 213513

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDETABLET;ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213513-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29

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
2026-08-18 06:07:402026-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a50c72e98297…

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
Goodmeds Levocetirizine Dihydrochloride 5mg 365 countLEVOCETIRIZINE DIHYDROCHLORIDE 5MGCabinet Health P.B.C.54f34304-952e-2f07-e063-6394a90a80ee2026-06-23WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEFarmacias De Similares TX LLC4ed17484-5609-d993-e063-6294a90a82a22026-04-06WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.f2a2a5bc-2efa-c550-e053-2a95a90a55ff2026-03-05WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESportpharm LLC8c00c74f-4377-4f2c-943e-e55afa5a824f2026-02-14Exact identifier
application applno (ANDA): 213513
application number: ANDA213513
ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEYYBA CORP8ee69332-742d-4071-95df-84bc42e170e72025-12-03WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
ndc (product): 73581-201
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.feabf140-e283-dcd5-e053-6394a90a29172025-04-16WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Allery Relief 24HRALLERY RELIEF 24HRAllegiant Healthc523c210-b1c4-4049-9c72-2b31c9c931372024-04-02WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Consumer Care Incbe72dafb-62ae-40b2-874f-1d8920fad19d2020-11-30Exact identifier
application applno (ANDA): 213513
application number: ANDA213513
ndc (product): 69230-321

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5341Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
50090-5341Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer CareANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer Care IncANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer CareANDACurrent
73581-201ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEYYBA CORPANDACurrent