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 2 of 6 · 114 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	YYBA Corp	53fe8ef5-ab65-f23e-e063-6394a90a30f0	2026-06-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	YYBA Corp	53e87aa4-9db3-9ded-e063-6294a90a319e	2026-06-10	Warnings	Name fallback 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 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
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	e8a00fa1-79af-4ce6-885f-0ce12c5da836	2026-04-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Goodmeds Non Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	ae1322f5-85d6-4243-b384-2ce7f8c8d692	2026-04-20	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
careone allergy relief	FEXOFENADINE HYDROCHLORIDE	Retail Business Services, LLC	ce398856-e9a6-401d-8636-bc5771a7e28b	2026-04-14	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173	2026-04-14	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	HyVee Inc	54635220-dd44-4baa-b929-9e52deb4c368	2026-03-25	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	YYBA CORP	2dd5e6b0-2445-4419-b0e6-c62aadee6ea4	2026-03-18	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
berkley jensen allergy relief	FEXOFENADINE HYDROCHLORIDE	BJWC	2c6d9f8c-bc74-4e1a-bd51-50f84ab63a15	2026-02-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Nuvicare Hives Relief	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	a8e11094-ca69-488d-a720-b8129f17f505	2026-01-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Gencare Hives Relief	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	ad0944f1-c5af-42cf-96c9-3140cbda66d8	2026-01-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HYVEE INC	3e61ffb1-1c52-1ad5-e063-6294a90a6e3f	2026-01-13	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	e2bd23c7-dfba-463a-adbe-2183970da740	2026-01-13	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Hives 24hr	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	490b4c5f-448b-4563-928b-837117b59b9f	2026-01-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	AMZ789 LLC	1e46343f-d6b6-73ba-e063-6394a90acd94	2026-01-07	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