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 44.

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 4 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`c0c555d07b60…`

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 1 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLERGY	FEXOFENADINE HYDROCHLORIDE	Amazon.com Services LLC	1b5aa481-205d-4935-ae58-fcb8cbc35c4c	2026-09-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	b21bb11d-bf74-4ee7-9cfe-5b599a3c4775	2026-08-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	5413d84e-f945-4920-8981-f62978f21d67	2026-08-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	683cb2ea-c913-48f4-8adc-2888da3b655e	2026-08-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	eb8e67dc-e2df-4c35-bfd7-12af67e1354a	2026-08-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
dg health aller ease	FEXOFENADINE HYDROCHLORIDE	Dolgencorp Inc	f9239aa4-b3d0-4817-b639-61ad1383f707	2026-08-05	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	dd0da52b-fc82-4ec9-854c-0d7c52e926fb	2026-08-03	Warnings	Name fallback 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 generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	864e3052-5787-bf11-9d17-11274ca2304f	2026-07-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	b0121213-eae1-8429-9986-3b3b26f35e47	2026-07-09	Warnings	Name fallback 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 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 generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Limited	e0537b71-fdee-4122-9c09-868ce7352080	2026-06-15	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	YYBA Corp	53fe8ef5-ab65-f23e-e063-6394a90a30f0	2026-06-11	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