Application 021441

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADVIL ALLERGY SINUS	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET;ORAL	2MG;200MG;30MG	Yes	Yes

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

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
N021441-001	ADVIL ALLERGY SINUS	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG;200MG;30MG	TABLET / ORAL		RLD, RS	2002-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021441-001	7863287	2027-02-28		Drug product	2011-05-06

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 · 41 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	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021441-001	ADVIL ALLERGY SINUS	2MG;200MG;30MG	TABLET / ORAL	RLD, RS	2002-12-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021441-001	7863287	2027-02-28	Drug product	2011-05-06	`cb3db0bc1861…`

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
ADVIL ALLERGY SINUS	CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	ecd6ea11-8b34-01b4-cbd9-901ba7a8f6e2	2026-03-23	Warnings	Exact identifier application applno (NDA): 021441 application number: NDA021441 ndc (product): 0573-0188

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
0573-0188	ADVIL ALLERGY SINUS	chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0188	ADVIL ALLERGY SINUS	chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0188	ADVIL ALLERGY SINUS	chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0188	ADVIL ALLERGY SINUS	chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69424	SUPPL	2021-11-30
69406	SUPPL	2021-11-24
48058	SUPPL	2017-04-18
48048	SUPPL	2017-04-17
5384	SUPPL	2010-09-07
27789	SUPPL	2009-05-27
27788	SUPPL	2008-06-24
5383	SUPPL	2006-03-01
36935	SUPPL	2004-07-14
5382	SUPPL	2004-07-14
27787	ORIG	2004-05-26
42167	ORIG	2004-04-21
36934	ORIG	2003-04-09