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 4 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	NUVICARE LLC	ec55732c-a3db-4445-a06d-0f98b21ed134	2025-06-09	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5	2025-06-01	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
exchange select aller ease	FEXOFENADINE HYDROCHLORIDE	Army & Air Force Exchange Service	6a9597a1-f024-4497-bc52-3d5482758822	2025-04-03	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
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 brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	SPIRIT PHARMACEUTICALS LLC	ae0f16f6-d07a-47e1-adb8-07803c6cfb13	2024-12-13	Warnings	Name fallback brand name: Fexofenadine Hydrochloride 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 brand name: Fexofenadine hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	KROGER COMPANY	7b146260-c925-3238-d092-24b7101ceb50	2024-11-12	Warnings	Name fallback brand name: Fexofenadine hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	624b3a91-af4f-8848-6fc3-392e0df34cc8	2024-11-12	Warnings	Name fallback brand name: Fexofenadine hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Health Corp.	204506d7-7688-fd7e-0aae-142b698848ef	2024-11-12	Warnings	Name fallback brand name: Fexofenadine Hydrochloride 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 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