Application 077081

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo
002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo
009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077081-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16
A077081-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11
A077081-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11
A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21
A077081-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21

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 10 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-1684e616aacf4f…
2026-09-14 22:38:342026-08A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-216a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077081-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077081-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077081-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077081-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077081-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077081-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077081-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077081-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077081-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077081-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077081-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077081-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077081-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077081-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077081-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077081-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077081-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077081-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077081-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077081-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077081-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077081-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077081-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077081-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077081-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077081-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077081-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077081-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077081-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077081-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077081-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077081-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077081-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077081-003AB1782e0a99824c…

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 4 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
exchange select aller easeFEXOFENADINE HYDROCHLORIDEArmy & Air Force Exchange Service6a9597a1-f024-4497-bc52-3d54827588222025-04-03WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Leader 24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECardinal Health 110, LLC. dba Leadere509800a-e33d-4d22-a6b4-97b7c73b14862025-04-01WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEFSA STORE INC.276e9767-93c0-5932-e063-6394a90ab2d92025-03-07WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.f061d6b1-89f7-4d5f-ac59-9c73408517c12025-02-19WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.06115cea-5a44-409d-85ed-bb71743491c12025-02-18WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLC5307b7ef-0c22-4aae-a2f6-033d31032f552024-12-13WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLCae0f16f6-d07a-47e1-adb8-07803c6cfb132024-12-13WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEWalgreen Company99f03481-d169-4aac-8370-20011ff530ea2024-12-13WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDEWal-Mart Stores Inc2432f862-6d7e-666d-e063-6294a90acf742024-12-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDollar General1b2a14a1-a5cc-4f5e-8127-57e9d913f50a2024-11-12WarningsName fallback
brand name: Fexofenadine hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEKROGER COMPANY7b146260-c925-3238-d092-24b7101ceb502024-11-12WarningsName fallback
brand name: Fexofenadine hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.624b3a91-af4f-8848-6fc3-392e0df34cc82024-11-12WarningsName fallback
brand name: Fexofenadine hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Health Corp.204506d7-7688-fd7e-0aae-142b698848ef2024-11-12WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEHARRIS TEETERc4f9e849-f286-4167-e053-2a95a90a38f92024-10-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCc5d58d74-da08-eb72-e053-2a95a90adc272024-10-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.5059ffc9-b116-4d11-9678-56c696f4e3db2024-08-16WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limited1d46555d-827b-b154-e063-6294a90ad3d52024-08-08WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDEA-S Medication Solutionsb5ce28f8-f6c3-4113-9317-e1c98e5030ef2024-07-30WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
allergy reliefFEXOFENADINE HYDROCHLORIDEMeijer, Inc.deecbf76-be1d-4b27-85c6-17cfb7e7d1a12024-07-25WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.c547c163-2a19-10d8-e053-2a95a90ac8172024-07-24WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE

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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0781Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0781Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0781Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0781Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0781Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0782Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0782Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0782Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0782Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
0378-0782Fexofenadine HydrochloridefexofenadineMylan Pharmaceuticals Inc.ANDACurrent
43353-760Fexofenadine HydrochloridefexofenadineAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-547Fexofenadine Hydrochloridefexofenadine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-547Fexofenadine Hydrochloridefexofenadine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-548Fexofenadine Hydrochloridefexofenadine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-548Fexofenadine Hydrochloridefexofenadine hydrochlorideMylan Institutional Inc.ANDACurrent
70518-0746Fexofenadine HydrochloridefexofenadineREMEDYREPACK INC.ANDACurrent
70518-0746Fexofenadine HydrochloridefexofenadineREMEDYREPACK INC.ANDACurrent