Application 079112

Type: ANDA
Sponsor: WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
003	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
004	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No
006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-08
A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-08
A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-08
A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-08
A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-08
A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-08

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 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`03ed91905a0d…`

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 3 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	Pioneer Life Sciences, LLC	d7fe71e4-aada-40f5-86a8-bf0d7eb9b851	2025-12-26	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	0a4f4178-bea5-4995-99dc-96980cccdc8a	2025-12-26	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
topcare allergy relief	FEXOFENADINE HYDROCHLORIDE	Topco Associates LLC	e7658b5f-2d78-4f25-b1a3-e49198ca8f32	2025-12-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	bb47b839-3f49-4818-a62c-b6d2b09b15dc	2025-12-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	YYBA CORP	a1e80757-346f-4d88-8da7-55583c3a902b	2025-11-26	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	9ed710e1-47f4-4d04-a509-12c8c97c192c	2025-11-05	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ValuMeds 24-Hour Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	036f8eaa-7eb9-46f4-b42e-3c8c7e49e450	2025-10-23	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	5237c8bd-0b20-4639-a740-f3001c4c2c94	2025-10-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
CVS Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Pharmacy	3d6c7b10-ed05-bbde-e063-6294a90ae92f	2025-10-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
good sense aller ease	FEXOFENADINE HYDROCHLORIDE	L. Perrigo Company	e533a008-b437-401e-ab50-bda31e6662d3	2025-10-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
up and up non drowsy allergy relief	FEXOFENADINE HYDROCHLORIDE	Target Corporation	d251b0a6-bc31-45b6-aaa8-f50f8336d959	2025-08-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Non-Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TARGET CORPORATION	3cf4b7fe-b1f7-b767-430a-655408f91753	2025-08-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	MAJOR PHARMACEUTICALS	0a6da401-a8a3-5d0b-f37e-c220838f7e49	2025-07-27	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	b961985e-0c18-b36f-d82e-32ff2d46fada	2025-07-18	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
24HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	b72c4802-1bcb-48bc-b4b9-72167ea4643e	2025-06-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	374f9271-b65b-69a9-e063-6394a90af36a	2025-06-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	ec55732c-a3db-4445-a06d-0f98b21ed134	2025-06-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5	2025-06-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
exchange select aller ease	FEXOFENADINE HYDROCHLORIDE	Army & Air Force Exchange Service	6a9597a1-f024-4497-bc52-3d5482758822	2025-04-03	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Leader 24HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	e509800a-e33d-4d22-a6b4-97b7c73b1486	2025-04-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11673-104	Allergy Relief	Fexofenadine HCl	TARGET Corporation	ANDA	Current
11673-104	Allergy Relief	Fexofenadine HCl	TARGET Corporation	ANDA	Current
11673-104	Allergy Relief	Fexofenadine HCl	TARGET Corporation	ANDA	Current
37012-189	Fexofenadine HCl	Fexofenadine HCl	Shopko Stores Operating Co., LLC.	ANDA	Current
53187-189	24 Hour Allergy	Fexofenadine HCl	LIVE BETTER (The Great Atlantic & Pacific Tea Company)	ANDA	Current
55648-744	Fexofenadine	Fexofenadine	Wockhardt Limited	ANDA	Current
55648-982	Fexofenadine	Fexofenadine	Wockhardt Limited	ANDA	Current
55648-987	Fexofenadine	Fexofenadine	Wockhardt Limited	ANDA	Current
59726-189	Allergy Relief	Fexofenadine HCl	P and L Development of New York Corporation	ANDA	Current
59726-504	Allergy Relief	Fexofenadine HCl	P & L Development, LLC	ANDA	Current
59726-504	Allergy Relief	Fexofenadine HCl	P & L Development, LLC	ANDA	Current
59726-504	Allergy Relief	Fexofenadine HCl	P & L Development, LLC	ANDA	Current
61715-049	Fexofenadine HCl	Fexofenadine HCl	Preferred Plus (Kinray)	ANDA	Current
61715-049	Fexofenadine HCl	Fexofenadine HCl	Preferred Plus (Kinray)	ANDA	Current
63868-024	Fexofenadine HCl	Fexofenadine HCl	Chain Drug Marketing Association	ANDA	Current
63868-141	Fexofenadine HCl	Fexofenadine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-141	Fexofenadine HCl	Fexofenadine HCl	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63941-189	Fexofenadine HCl	Fexofenadine HCl	Valu Merchandisers Company (Best Choice)	ANDA	Current
63941-504	Allergy Relief	Fexofenadine HCl	Best Choice (Valu Merchandisers Company)	ANDA	Current
63941-504	Allergy Relief	Fexofenadine HCl	Best Choice (Valu Merchandisers Company)	ANDA	Current
63941-504	Allergy Relief	Fexofenadine HCl	Best Choice (Valu Merchandisers Company)	ANDA	Current
64679-744	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-744	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-744	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-744	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-744	Fexofenadine	Fexofenadine	Wockhardt USA LLC.	ANDA	Current
64679-744	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-982	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-982	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-982	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-982	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-982	Fexofenadine	Fexofenadine	Wockhardt USA LLC.	ANDA	Current
64679-982	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-987	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-987	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-987	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-987	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-987	Fexofenadine	Fexofenadine	Wockhardt USA LLC.	ANDA	Current
64679-987	ALLERGY 24-HR	FEXOFENADINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
68016-119	Fexofenadine HCl	Fexofenadine HCl	Chain Drug Consortium, LLC	ANDA	Current
69842-704	Allergy Relief	Fexofenadine HCl	CVS Pharmacy	ANDA	Current
69842-704	Allergy Relief	Fexofenadine HCl	CVS Pharmacy	ANDA	Current
69842-704	Allergy Relief	Fexofenadine HCl	CVS Pharmacy	ANDA	Current
71141-139	Allergy Relief	Fexofenadine HCl	Lidl US, LLC	ANDA	Current
71141-139	Allergy Relief	Fexofenadine HCl	Lidl US, LLC	ANDA	Current