Application 021909

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	30MG	Yes	No
003	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	30MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021909-002	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2011-01-24
N021909-003	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2011-01-24

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`3a93d1ddd44b…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	06115cea-5a44-409d-85ed-bb71743491c1	2025-02-18	Warnings	Exact identifier application applno (NDA): 021909 application number: NDA021909 ndc (product): 41167-4232

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
41167-4232	Childrens Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4232	Childrens Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4232	Childrens Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4232	Childrens Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4232	Childrens Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65924	SUPPL	2021-01-19
65509	SUPPL	2020-12-07
37866	SUPPL	2016-06-17
6436	SUPPL	2016-06-14
37865	SUPPL	2013-11-26
16560	SUPPL	2013-11-21
28829	SUPPL	2013-04-30
6435	SUPPL	2012-08-27
28828	SUPPL	2011-01-27
42347	ORIG	2009-03-12
28827	ORIG	2007-07-30
16559	ORIG	2007-07-30