Application 077081

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No
002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No
009	FEXOFENADINE HYDROCHLORIDE HIVES	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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077081-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2007-04-16
A077081-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2008-04-11
A077081-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2008-04-11
A077081-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-07-21
A077081-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-07-21
A077081-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-07-21
A077081-007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-07-21
A077081-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-07-21
A077081-009	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-07-21

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077081-001	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2007-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-002	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2008-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-003	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2008-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077081-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077081-001	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2007-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-002	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2008-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-003	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2008-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077081-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077081-001	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2007-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-002	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2008-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-003	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2008-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-001	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2007-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-002	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2008-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-003	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2008-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077081-001	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2007-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077081-002	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2008-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077081-003	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2008-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077081-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-07-21	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077081-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077081-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077081-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077081-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077081-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077081-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077081-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077081-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077081-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077081-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077081-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077081-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077081-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077081-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077081-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077081-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077081-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077081-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077081-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077081-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077081-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077081-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077081-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077081-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077081-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077081-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077081-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077081-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077081-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077081-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077081-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077081-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077081-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077081-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077081-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077081-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077081-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077081-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077081-003	AB	1	`782e0a99824c…`

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 6 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Rite Aid Corporation	af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce	2022-06-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	7cb25829-3aee-4a82-869d-ab4259626584	2022-05-31	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	d8b852a1-7315-4047-aed6-cd40c7a39e70	2022-05-31	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	e43b561e-d68a-47af-be93-d710f0f77505	2022-02-22	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Wal-Fex	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	95d420ea-6337-304f-54c3-0c75be1608e2	2022-01-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	Publix Super Markets Inc	76014f1e-fa48-4d64-9ce6-1eaebd0419fc	2022-01-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	DISCOUNT DRUG MART	c5106c63-af53-c169-e053-2a95a90afef2	2021-11-30	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	c1be67ea-9973-49e2-e053-2995a90a423c	2021-10-24	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
12HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH	ea5d0e55-2191-4094-b082-24b317f95752	2021-09-24	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Family Dollar Stores, Inc.	f532e9d5-6457-8bef-e83e-16050f20b03c	2020-02-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Sam's West Inc.	1c1f43c4-7128-37c4-83fe-7eefac3fd477	2019-10-07	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	7-eleven	d5914c05-e8db-4c79-82d0-a279d1304118	2019-06-20	Warnings	Name fallback brand name: Fexofenadine hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway Inc	3c30a1dc-a13d-2522-d4d0-00c1e9dbab07	2017-12-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Consortium, LLC	d1d8d0ec-2bdd-fb07-a051-d6353e3c240c	2014-01-22	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Associate	8a1de8a1-808a-bc08-6c74-957d6f388eab	2014-01-22	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-760	Fexofenadine Hydrochloride	fexofenadine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-547	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-547	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-548	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-548	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
70518-0746	Fexofenadine Hydrochloride	fexofenadine	REMEDYREPACK INC.	ANDA	Current
70518-0746	Fexofenadine Hydrochloride	fexofenadine	REMEDYREPACK INC.	ANDA	Current