FDA.reportPublic FDA data

Application 210137

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

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
A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2018-08-13

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 UTC2022-10A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEYYBA Corp53fe8ef5-ab65-f23e-e063-6394a90a30f02026-06-11WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
FEXOFENADINE HClFEXOFENADINE HCLStrategic Sourcing Services, LLC7a49f700-5892-404b-b81a-4a92c19288062026-01-29WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
Nuvicare Hives ReliefFEXOFENADINE HYDROCHLORIDENUVICARE LLCa8e11094-ca69-488d-a720-b8129f17f5052026-01-21WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
Gencare Hives ReliefFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCad0944f1-c5af-42cf-96c9-3140cbda66d82026-01-21WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCd7fe71e4-aada-40f5-86a8-bf0d7eb9b8512025-12-26WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLC0a4f4178-bea5-4995-99dc-96980cccdc8a2025-12-26WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENUVICARE LLCbb47b839-3f49-4818-a62c-b6d2b09b15dc2025-12-19WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
CVS Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Pharmacy3d6c7b10-ed05-bbde-e063-6294a90ae92f2025-10-22WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENUVICARE LLCec55732c-a3db-4445-a06d-0f98b21ed1342025-06-09WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCd3b6f04c-60d6-4ac3-9fb2-19eeb80f00a52025-06-01WarningsExact identifier
application applno (ANDA): 210137
application number: ANDA210137

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 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-1220FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-4148FEXOFENADINE HClFEXOFENADINE HClSpirit Pharmaceuticals LLCANDACurrent
68210-4148FEXOFENADINE HClFEXOFENADINE HClSpirit Pharmaceuticals LLCANDACurrent
68210-4148FEXOFENADINE HClFEXOFENADINE HClSpirit Pharmaceuticals LLCANDACurrent
72476-121FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDERETAIL BUSINESS SERVICES, LLCANDACurrent
72476-126FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDERETAIL BUSINESS SERVICES, LLCANDACurrent