Application 018989

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADVIL	IBUPROFEN	TABLET;ORAL	200MG	No	No

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
N018989-001	ADVIL	IBUPROFEN	200MG	TABLET / ORAL		RLD, RS	1984-05-18

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 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	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL	IBUPROFEN	Select Consumer Group	3ca752d8-957c-21b4-e063-6294a90a5285	2026-07-03	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN	Navajo Manufacturing Company Inc.	4a64522f-b7d8-47f7-bf07-c9e8f1086425	2026-04-08	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989 ndc (product): 67751-146
ADVIL	IBUPROFEN	Haleon US Holdings LLC	1a665e64-9f30-be37-4a83-38789f1f1e89	2026-03-12	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989 ndc (product): 0573-0151 ndc (product): 0573-0160 ndc (product): 0573-1711 ndc (product): 0573-0154 ndc (product): 0573-0161 ndc (product): 0573-0165 ndc (product): 0573-0150 ndc (product): 0573-0166
Advil	IBUPROFEN	JC World Bell Wholesale Co., Inc.	0b83c9ed-3630-4c5c-9020-cf38183a6500	2025-06-27	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN	Lil' Drug Store Products, Inc.	772360bd-8631-4d24-b4db-5a7e6e1d9a13	2025-01-27	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989 ndc (product): 66715-9700
Advil	IBUPROFEN TABLETS, COATED	Lil' Drug Store Products, Inc.	dd302e18-39e9-7e1a-e053-2a95a90a5f7c	2024-07-17	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989 ndc (product): 66715-5803

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0573-0150	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0150	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0150	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0150	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0150	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0150	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0151	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0151	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0151	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0151	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0151	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0151	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0154	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0154	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0154	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0154	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0154	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0154	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0160	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0160	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0160	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0160	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0160	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0160	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0161	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0161	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0161	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0161	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0161	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0161	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0165	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0165	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0165	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0165	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0165	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0165	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0166	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0166	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0166	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0166	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0166	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0166	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-1711	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-1711	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-1711	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-1711	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-1711	ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-1711	ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
29485-1005	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-1005	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-1005	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-6500	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-6749	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-6749	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-6749	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-7012	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-7012	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
29485-7012	ADVIL	IBUPROFEN Tablet coated	Mechanical Servants LLC	NDA	Current
52904-786	ADVIL	ibuprofen	Wyeth Pharmaceuticals Company	NDA	Current
52904-790	ADVIL	ibuprofen	Wyeth Pharmaceuticals Company	NDA	Current
52904-791	ADVIL	ibuprofen	Wyeth Pharmaceuticals Company	NDA	Current
52904-794	ADVIL	ibuprofen	Wyeth Pharmaceuticals Company	NDA	Current
66715-5803	Advil	Ibuprofen Tablets, coated	Lil' Drug Store Products, Inc.	NDA	Current
66715-9700	Advil	Ibuprofen	Lil' Drug Store Products, Inc.	NDA	Current
66715-9700	Advil	Ibuprofen	Lil' Drug Store Products, Inc.	NDA	Current
66715-9700	Advil	Ibuprofen	Lil' Drug Store Products, Inc.	NDA	Current
66715-9700	Advil	Ibuprofen	Lil' Drug Store Products, Inc.	NDA	Current
66715-9700	Advil	Ibuprofen	Lil' Drug Store Products, Inc.	NDA	Current
67751-146	Advil	IBUPROFEN	Navajo Manufacturing Company Inc.	NDA	Current
67751-146	Advil	IBUPROFEN	Navajo Manufacturing Company Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81685	SUPPL	2025-03-24
80803	SUPPL	2025-01-02
69581	SUPPL	2021-12-16
69580	SUPPL	2021-12-16
56483	SUPPL	2018-11-23
56489	SUPPL	2018-11-16
55926	SUPPL	2018-10-15
55882	SUPPL	2018-10-11
49622	SUPPL	2017-08-30
49575	SUPPL	2017-08-29
11407	SUPPL	2015-12-22
1186	SUPPL	2015-12-18
33680	SUPPL	2012-03-27
1184	SUPPL	2011-04-28
1185	SUPPL	2010-09-07
16163	SUPPL	2009-05-26
1183	SUPPL	2008-06-13
16162	SUPPL	2007-05-07
11406	SUPPL	2007-05-07
16161	SUPPL	2006-04-20
1182	SUPPL	2006-04-07
1181	SUPPL	2004-07-21
16159	SUPPL	2004-05-26
11404	SUPPL	2004-05-26
16160	SUPPL	2003-09-30
11405	SUPPL	2003-09-30
11403	SUPPL	2003-04-23