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 43.

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 · 258 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	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
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…`

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 4 of 6 · 114 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	FSA STORE INC.	276e9767-93c0-5932-e063-6394a90ab2d9	2025-03-07	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	f061d6b1-89f7-4d5f-ac59-9c73408517c1	2025-02-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	06115cea-5a44-409d-85ed-bb71743491c1	2025-02-18	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	SPIRIT PHARMACEUTICALS LLC	5307b7ef-0c22-4aae-a2f6-033d31032f55	2024-12-13	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	SPIRIT PHARMACEUTICALS LLC	ae0f16f6-d07a-47e1-adb8-07803c6cfb13	2024-12-13	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Walgreen Company	99f03481-d169-4aac-8370-20011ff530ea	2024-12-13	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Wal-Mart Stores Inc	2432f862-6d7e-666d-e063-6294a90acf74	2024-12-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dollar General	1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	2024-11-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	KROGER COMPANY	7b146260-c925-3238-d092-24b7101ceb50	2024-11-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	624b3a91-af4f-8848-6fc3-392e0df34cc8	2024-11-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Health Corp.	204506d7-7688-fd7e-0aae-142b698848ef	2024-11-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HARRIS TEETER	c4f9e849-f286-4167-e053-2a95a90a38f9	2024-10-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG CONSORTIUM	8eee26c2-af58-469c-b855-c3bfc8bd7e2d	2024-10-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	c5d58d74-da08-eb72-e053-2a95a90adc27	2024-10-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	5059ffc9-b116-4d11-9678-56c696f4e3db	2024-08-16	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Limited	1d46555d-827b-b154-e063-6294a90ad3d5	2024-08-08	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
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

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 · 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