Application 201311

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	SUSPENSION;ORAL	30MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201311-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL			2012-07-25

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 · 43 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	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201311-001	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL	2012-07-25	`f41ea6bd6efb…`

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 6 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Proficient Rx LP	4a9b4b7f-0441-44d3-86c7-2542ef4b119a	2022-12-01	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HARRIS TEETER	e5429440-fc89-4200-e053-2995a90afc7d	2022-11-23	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	MARC GLASSMAN, INC.	c4f93336-cfd8-e023-e053-2995a90a9df0	2022-10-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Rite Aid Corporation	af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce	2022-06-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	7cb25829-3aee-4a82-869d-ab4259626584	2022-05-31	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	d8b852a1-7315-4047-aed6-cd40c7a39e70	2022-05-31	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	e43b561e-d68a-47af-be93-d710f0f77505	2022-02-22	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Wal-Fex	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	95d420ea-6337-304f-54c3-0c75be1608e2	2022-01-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	Publix Super Markets Inc	76014f1e-fa48-4d64-9ce6-1eaebd0419fc	2022-01-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	DISCOUNT DRUG MART	c5106c63-af53-c169-e053-2a95a90afef2	2021-11-30	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	c1be67ea-9973-49e2-e053-2995a90a423c	2021-10-24	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
12HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH	ea5d0e55-2191-4094-b082-24b317f95752	2021-09-24	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Family Dollar Stores, Inc.	f532e9d5-6457-8bef-e83e-16050f20b03c	2020-02-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Sam's West Inc.	1c1f43c4-7128-37c4-83fe-7eefac3fd477	2019-10-07	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	7-eleven	d5914c05-e8db-4c79-82d0-a279d1304118	2019-06-20	Warnings	Name fallback brand name: Fexofenadine hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway Inc	3c30a1dc-a13d-2522-d4d0-00c1e9dbab07	2017-12-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Consortium, LLC	d1d8d0ec-2bdd-fb07-a051-d6353e3c240c	2014-01-22	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Associate	8a1de8a1-808a-bc08-6c74-957d6f388eab	2014-01-22	Warnings	Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9886	ORIG	2012-07-30