Application 021704

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	180MG;240MG	Yes	Yes

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
N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`f41ea6bd6efb…`

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	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`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
Allegra-D Allergy and Congestion	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Chattem, Inc.	1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403	2026-01-12	Warnings	Exact identifier application applno (NDA): 021704 application number: NDA021704 ndc (product): 41167-4320

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
41167-4320	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current
41167-4320	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current
41167-4320	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current
41167-4320	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
16233	SUPPL	2016-06-10
28421	SUPPL	2016-06-07
16232	SUPPL	2015-06-19
28420	SUPPL	2015-06-10
16231	SUPPL	2013-11-26
37491	SUPPL	2013-09-13
28419	SUPPL	2012-12-11
6023	SUPPL	2012-08-27
28418	SUPPL	2012-02-13
28417	SUPPL	2011-01-27
16230	SUPPL	2010-04-19
6022	SUPPL	2010-04-19
42277	ORIG	2005-09-13
28416	ORIG	2004-10-26
16229	ORIG	2004-10-26