FDA.reportPublic FDA data

Application 202039

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2014-11-19
A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2014-11-19
A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2014-11-19

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
2026-08-01 22:54:322026-06A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19a50c72e98297…
2026-08-01 22:54:322026-06A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19a50c72e98297…
2026-08-01 22:54:322026-06A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDE7-elevend5914c05-e8db-4c79-82d0-a279d13041182019-06-20WarningsExact identifier
application applno (ANDA): 202039
application number: ANDA202039
ndc (product): 10202-229

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0095Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
0363-0095Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
0363-0097Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
0363-0097Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
10202-229Fexofenadine hydrochlorideFexofenadine hydrochloride7-elevenANDACurrent
13107-066Fexofenadine hydrochlorideFexofenadine hydrochlorideAurolife Pharma, LLCANDACurrent
13107-067Fexofenadine hydrochlorideFexofenadine hydrochlorideAurolife Pharma, LLCANDACurrent
42291-296Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKARE, Inc.ANDACurrent
42291-297Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKARE, Inc.ANDACurrent
42291-297Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKARE, Inc.ANDACurrent
42291-297Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKAREANDACurrent
46122-387Fexofenadine hydrochlorideFexofenadine hydrochlorideAmerisource BergenANDACurrent
46122-387Fexofenadine hydrochlorideFexofenadine hydrochlorideAmerisource BergenANDACurrent
49035-995Fexofenadine hydrochlorideFexofenadine hydrochlorideWal-Mart Stores, IncANDACurrent
49035-995Fexofenadine hydrochlorideFexofenadine hydrochlorideWal-Mart Stores, IncANDACurrent
50268-315Fexofenadine hydrochlorideFexofenadine hydrochlorideAvPAKANDACurrent
50268-316Fexofenadine hydrochlorideFexofenadine hydrochlorideAvPAKANDACurrent
50268-317Fexofenadine hydrochlorideFexofenadine hydrochlorideAvPAKANDACurrent
53217-363Fexofenadine hydrochlorideFexofenadine hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53943-021Fexofenadine hydrochlorideFexofenadine hydrochlorideDiscount Drug MartANDACurrent
53943-021Fexofenadine hydrochlorideFexofenadine hydrochlorideDiscount Drug MartANDACurrent
54257-001Fexofenadine hydrochlorideFexofenadine hydrochlorideMagno-Humphries Labs, Inc.ANDACurrent
54257-001Fexofenadine hydrochlorideFexofenadine hydrochlorideMagno-Humphries Labs, Inc.ANDACurrent
55315-355Fexofenadine hydrochlorideFexofenadine hydrochlorideFredsANDACurrent
55315-355Fexofenadine hydrochlorideFexofenadine hydrochlorideFred'sANDACurrent
58602-710Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
58602-710Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
58602-711Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
58602-711Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
60000-409Fexofenadine hydrochlorideFexofenadine hydrochlorideAhold U.S.A., IncANDACurrent
60000-409Fexofenadine hydrochlorideFexofenadine hydrochlorideAhold U.S.A., IncANDACurrent
62011-0314Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
62011-0314Fexofenadine hydrochlorideFexofenadine hydrochlorideHealthmartANDACurrent
62011-0315Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
62011-0315Fexofenadine hydrochlorideFexofenadine hydrochlorideHealthmartANDACurrent
68071-1896Fexofenadine hydrochlorideFexofenadine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1896Fexofenadine hydrochlorideFexofenadine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68196-976Fexofenadine hydrochlorideFexofenadine hydrochlorideSam's West IncANDACurrent
68196-976Fexofenadine hydrochlorideFexofenadine hydrochlorideSam's West IncANDACurrent
68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-1218Fexofenadine hydrochlorideFexofenadine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1218Fexofenadine hydrochlorideFexofenadine hydrochlorideREMEDYREPACK INC.ANDACurrent
70677-0007Fexofenadine hydrochlorideFexofenadine hydrochlorideSunmarkANDACurrent
70677-0007Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
70677-0008Fexofenadine hydrochlorideFexofenadine hydrochlorideSunmarkANDACurrent
70677-0008Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
71335-0483Fexofenadine hydrochlorideFexofenadine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0483Fexofenadine hydrochlorideFexofenadine hydrochlorideBryant Ranch PrepackANDACurrent
71610-292Fexofenadine hydrochlorideFexofenadine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent