Application 076298

Type: ANDA
Sponsor: IMPAX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	60MG;120MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2010-11-12

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 2 · 42 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	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076298-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2010-11-12	`e64feba35796…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	4726af84-83c1-456d-995c-f6a8d1583f8b	2026-05-27	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	ac67476a-2888-53c4-0a10-7f73ac2580c5	2025-12-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Rite Aid Corporation	0834bda9-e793-ad67-7f71-d2ffce47e5fc	2025-12-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreens Company	db671b6e-7233-8872-0227-6da62d6b6507	2025-12-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Wal-mart Stores, Inc.	a0ce5002-08e3-c21f-9b88-f3dd27dc9dda	2025-12-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	23fdb518-8dcc-3671-f116-ea8c7b0a6e08	2025-12-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Health Corp	b009e6b1-57da-a002-1a9e-38a96cc041f1	2025-12-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	AmeriSource Bergen	4a8df3c9-bed3-4371-a1c1-59afe12203e2	2025-11-14	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	87ab4578-84de-475d-a4b0-eec969f17253	2025-11-13	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	bced0a2e-047e-456e-bbd2-495e83bf07ee	2025-04-18	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	8afc0167-17bf-4ccd-91c9-8fb9c4e241c1	2025-03-11	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	75236b23-af51-40b6-ad1b-f62a27093a16	2024-10-10	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN CO.	1fcb601c-19d2-4db9-938b-b4f98ba9332f	2024-06-26	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy, Inc.	e9161bb2-190f-14b3-e053-2995a90a9b2f	2024-06-01	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	walgreens	1ed05c85-7a1c-440d-a5d7-e229528cedcd	2024-05-28	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	KROGER COMPANY	b8b2c45d-3aba-d98a-e053-2a95a90a879b	2024-05-18	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health	c3b40d04-7eef-4c80-a604-808d2be72ad7	2024-05-06	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Rugby Laboratories	cc6df813-9175-4c0b-a8e4-afcaa3aa833f	2024-05-06	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	45d3ad69-a80a-4f91-9c9b-8b19a30144a3	2024-04-26	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	H E B	5167ab78-f898-47ec-8baf-843269469d10	2018-07-18	Warnings	Name fallback brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22553	ORIG	2013-01-24