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 44.

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-08-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-08-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-08-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-08-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-08-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-08-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-08-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-08-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-08-31	`3a93d1ddd44b…`

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 1 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLERGY	FEXOFENADINE HYDROCHLORIDE	Amazon.com Services LLC	1b5aa481-205d-4935-ae58-fcb8cbc35c4c	2026-09-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE ORAL	Aurohealth LLC	fe864426-c0d6-492a-96be-cd44fd9ca054	2026-09-01	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	b21bb11d-bf74-4ee7-9cfe-5b599a3c4775	2026-08-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	5413d84e-f945-4920-8981-f62978f21d67	2026-08-06	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	683cb2ea-c913-48f4-8adc-2888da3b655e	2026-08-06	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	eb8e67dc-e2df-4c35-bfd7-12af67e1354a	2026-08-06	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
dg health aller ease	FEXOFENADINE HYDROCHLORIDE	Dolgencorp Inc	f9239aa4-b3d0-4817-b639-61ad1383f707	2026-08-05	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	dd0da52b-fc82-4ec9-854c-0d7c52e926fb	2026-08-03	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
HIVES RELIEF	FEXOFENADINE HYDROCHLORIDE	Walgreen Company	a79edb5d-02d9-4c53-9509-c69fd6115686	2026-07-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Kroger Company	2718d6a2-0678-4703-9a5a-26b27d753942	2026-07-20	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
equate allergy relief	FEXOFENADINE HYDROCHLORIDE	Walmart Inc.	852c8ad2-fc7d-4728-b2c6-f64b960fe2ab	2026-07-18	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	BluePoint Laboratories	a86aebd0-937e-5d73-e053-2995a90a656a	2026-07-13	Warnings	Name fallback brand name: Fexofenadine hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	864e3052-5787-bf11-9d17-11274ca2304f	2026-07-09	Warnings	Name fallback brand name: Fexofenadine hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	b0121213-eae1-8429-9986-3b3b26f35e47	2026-07-09	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CVS PHARMACY	c77ee2bb-dc95-d8c9-e053-2995a90a9602	2026-07-08	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Allergy	FEXOFENADINE HYDROCHLORIDE	H2-Pharma, LLC	84988f6d-85b1-45dd-89be-0333acc6b180	2026-06-25	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	58193632-2468-4159-b1a9-c24a489f199f	2026-06-24	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
Gencare-Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	a8595b29-1ea3-44aa-b131-030f34f408fc	2026-06-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Ltd	3151bc6d-b40b-4200-a5cf-e57b6791d92a	2026-06-15	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Limited	e0537b71-fdee-4122-9c09-868ce7352080	2026-06-15	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.