Application 020786

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	60MG;120MG	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
N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	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	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`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 1 of 1 · 2 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.	b32e172a-abf5-4c17-aa39-19e517952b91	2026-01-12	Warnings	Exact identifier application applno (NDA): 020786 application number: NDA020786 ndc (product): 41167-4310
ALLEGRA-D	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	705e1087-61cb-43c3-8675-f56626a1707b	2024-01-07	Warnings	Exact identifier application applno (NDA): 020786 application number: NDA020786 ndc (product): 50090-1203

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-820	FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE	Rebel Distributors Corp	NDA	Current
21695-931	Allegra D 12 Hour Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Rebel Distributors Corp	NDA	Current
41167-4310	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current
41167-4310	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current
41167-4310	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current
41167-4310	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	Chattem, Inc.	NDA	Current
50090-1203	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	A-S Medication Solutions	NDA	Current
50090-1203	Allegra-D Allergy and Congestion	fexofenadine hydrochloride and pseudoephedrine hydrochloride	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
35361	SUPPL	2016-06-10
3362	SUPPL	2016-06-07
13441	SUPPL	2015-06-19
25841	SUPPL	2015-06-10
13440	SUPPL	2013-01-08
3361	SUPPL	2012-12-11
35360	SUPPL	2012-10-12
3360	SUPPL	2012-08-27
35359	SUPPL	2012-03-27
3359	SUPPL	2012-02-13
25840	SUPPL	2011-01-27
41701	ORIG	2010-05-25
13439	SUPPL	2010-04-19
3358	SUPPL	2010-04-19
41705	SUPPL	2008-08-08
41703	SUPPL	2008-08-08
41702	SUPPL	2008-08-08
20954	SUPPL	2008-08-08
41707	SUPPL	2008-08-04
41706	SUPPL	2008-08-04
41704	SUPPL	2008-08-04
20955	SUPPL	2007-08-06
3357	SUPPL	2003-06-08
13438	SUPPL	2003-05-29
3356	SUPPL	2002-11-01