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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077081-001	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2007-04-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-002	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2008-04-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-003	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2008-04-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2011-07-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2011-07-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2011-07-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2011-07-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2011-07-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077081-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2011-07-21	`a50c72e98297…`

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 6 · 113 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	dd0da52b-fc82-4ec9-854c-0d7c52e926fb	2026-07-30	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
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	YYBA Corp	53fe8ef5-ab65-f23e-e063-6394a90a30f0	2026-06-11	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	YYBA Corp	53e87aa4-9db3-9ded-e063-6294a90a319e	2026-06-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy 24 hour	FEXOFENADINE HYDROCHLORIDE	Select Consumer Group	2de81a41-8488-7e39-e063-6294a90a394b	2026-06-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Grocery Outlet, Inc.	441ce66e-515a-d380-e063-6394a90aec7d	2026-05-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	895de6e9-c5b6-42fe-b450-f5d8331ce2e3	2026-05-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	OHM LABORATORIES INC.	1a1afa95-570d-456e-b436-a0fcfaf68517	2026-05-05	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy, Travel BASIX	FEXOFENADINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	b82d993a-16ff-4037-a182-7010de8e1cdd	2026-04-27	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE

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