Application 203330

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	SUSPENSION;ORAL	30MG/5ML	No	No
002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	SUSPENSION;ORAL	30MG/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL			2014-11-18
A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL		RS	2014-11-18

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`782e0a99824c…`

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy	FEXOFENADINE HYDROCHLORIDE	H2-Pharma, LLC	84988f6d-85b1-45dd-89be-0333acc6b180	2026-06-25	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330 ndc (product): 61269-527
Children Allergy	FEXOFENADINE HCL	H E B	a26c3515-4a24-4988-b9bb-813420b15630	2026-05-12	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	CVS PHARMACY, INC	4ab89e0a-d5aa-481b-8793-c940a27ebeb2	2026-05-11	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	Family Dollar (FAMILY WELLNESS)	f7114f9d-5708-497a-8390-a11a82c8d84f	2026-05-06	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	H E B	3b6f4a4b-b1bd-4062-9e7f-571b836b1536	2026-05-06	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330 ndc (product): 37808-623
Dye Free Wal Fex childrens allergy	FEXOFENADINE HCL	Walgreens	9062c258-4c3e-412d-a31f-1e748a67513f	2025-09-02	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330 ndc (product): 0363-9230
Children Allergy	FEXOFENADINE HCL	Walgreens	30517ea8-0a97-4c8f-ad95-739a103784c5	2025-09-02	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	Family Dollar (FAMILY WELLNESS)	ba4df76e-cbed-4e19-afc6-c76000f0bf4f	2024-06-04	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	WALMART INC. (see also Equate)	fb163eea-b2d2-4f52-9123-0bbe28baf757	2024-03-22	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	667c87c2-c594-49e5-92a7-f8aa140642d6	2023-10-11	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330 ndc (product): 49035-208

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9230	Dye Free Wal Fex	Fexofenadine HCL	Walgreens	ANDA	Current
0363-9230	Dye Free Wal Fex	Fexofenadine HCL	Walgreens	ANDA	Current
0363-9230	Dye Free Wal Fex	Fexofenadine HCL	Walgreens	ANDA	Current
0363-9230	Dye Free Wal Fex	Fexofenadine HCL	Walgreens	ANDA	Current
0363-9230	Dye Free Wal Fex	Fexofenadine HCL	Walgreens	ANDA	Current
37808-623	Childrens Allergy	Fexofenadine HCL	H E B	ANDA	Current
49035-208	Childrens Allergy	Fexofenadine HCL	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-208	Childrens Allergy	Fexofenadine HCL	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
61269-527	Childrens Allergy	fexofenadine hydrochloride	H2-Pharma, LLC	ANDA	Current
63941-923	Childrens Allergy	Fexofenadine HCL	Best Choice (Valu Merchandisers Company)	ANDA	Current
69842-923	Allergy Relief	Fexofenadine HCL	CVS Pharmacy	ANDA	Current
69842-923	Allergy Relief	Fexofenadine HCL	CVS Pharmacy	ANDA	Current