Application 076191

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076191-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31
A076191-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31
A076191-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076191-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076191-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076191-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076191-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076191-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076191-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076191-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076191-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076191-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076191-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076191-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076191-003	AB	1	`ea99ee380514…`

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 5 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	A-S Medication Solutions	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	2024-07-30	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	Meijer, Inc.	deecbf76-be1d-4b27-85c6-17cfb7e7d1a1	2024-07-25	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	c547c163-2a19-10d8-e053-2a95a90ac817	2024-07-24	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
basic care allergy	FEXOFENADINE HYDROCHLORIDE	Amazon.com Services LLC	c2f30390-3d32-4489-9df2-caf848ce040b	2024-07-17	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	CVS PHARMACY, INC	7bc13851-291a-4582-8261-13c5022fbdd1	2024-05-24	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	AMERISOURCE BERGEN	2a578643-adc1-44ca-83f2-9d48527bd3a4	2024-05-14	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
Basic Care Allergy	FEXOFENADINE HYDROCHLORIDE	Amazon.com Services LLC	27202f58-a488-42cc-b63f-be892c5b4de2	2024-05-10	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Basic Care Allergy	FEXOFENADINE HYDROCHLORIDE	Amazon.com Services LLC	c29d281f-89dd-4c69-8572-6599400c660f	2024-04-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	Walgreen Company	a0738300-7262-4e43-89a6-0d0a60bd14bd	2024-02-14	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway, Inc.	348b79cf-1184-46d4-a0e5-fdc24afec1a5	2024-02-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Magno-Humphries, Inc.	1f8a2f98-7eba-48df-9589-58587d67ae0e	2024-01-03	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dc0893-b81b-4f96-e053-6294a90a856f	2023-11-02	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	c4f9224c-4c3d-74bd-e053-2995a90a1452	2023-10-30	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE ORAL	Aurohealth LLC	e8e35d7a-a86b-4d37-979b-f454978f070b	2023-06-06	Warnings	Name fallback brand name: Fexofenadine Hydrochloride
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	fabb8c0d-b4da-ab73-e053-6394a90ab8b5	2023-05-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	ccff9b0f-8ae5-057f-e053-2a95a90ac2b1	2023-05-17	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
kirkland signature aller fex	FEXOFENADINE HYDROCHLORIDE	Costco Wholesale Company	651d14d1-c5de-4cb9-9484-b05986e641ac	2023-05-02	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	de438313-9790-b4ea-2d28-7a19836cf5e2	2023-04-21	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Crcle Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Innovus Pharmaceuticals, Inc.	f7784610-7ca5-4489-b391-f2b3f3f6549b	2023-04-08	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Safrel Pharmaceuticals, LLC.	d6120f56-ab28-2696-e053-2995a90adf47	2023-03-28	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.