Application 077349

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	No	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
A077349-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL		RS	2005-06-21

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	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen 200mg	IBUPROFEN 200MG	Allegiant Health	51e95588-39af-40d6-9924-e98d42af15b9	2018-12-31	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349

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 2 · 120 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0074	Good Sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0074	Good Sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0517	Good Sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0517	Good Sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0517	Good Sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-7517	basic care ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-7517	basic care ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0363-1517	ibuprofen 200	Ibuprofen	Walgreen Company	ANDA	Current
11673-183	up and up ibuprofen	Ibuprofen	Target Corporation	ANDA	Current
11673-183	up and up ibuprofen	Ibuprofen	Target Corporation	ANDA	Current
11673-517	up and up ibuprofen	Ibuprofen	Target Corporation	ANDA	Current
11673-517	up and up ibuprofen	Ibuprofen	Target Corporation	ANDA	Current
21130-877	signature care ibuprofen	Ibuprofen	Safeway	ANDA	Current
21130-877	signature care ibuprofen	Ibuprofen	Safeway	ANDA	Current
24385-058	Good Neighbor Pharmacy ibuprofen	Ibuprofen	Amerisource Bergen	ANDA	Current
24385-058	Good Neighbor Pharmacy ibuprofen	Ibuprofen	Amerisource Bergen	ANDA	Current
24385-059	Good Neighbor Pharmacy ibuprofen	Ibuprofen	Amerisource Bergen	ANDA	Current
24385-059	Good Neighbor Pharmacy ibuprofen	Ibuprofen	Amerisource Bergen	ANDA	Current
24385-059	Good Neighbor Pharmacy ibuprofen	Ibuprofen	Amerisource Bergen	ANDA	Current
24385-059	Good Neighbor Pharmacy ibuprofen	Ibuprofen	Amerisource Bergen	ANDA	Current
30142-074	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
30142-074	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
30142-183	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
30142-183	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
30142-183	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
30142-517	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
30142-517	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
30142-517	ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
36800-074	Topcare Ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-074	Topcare Ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-074	Topcare Ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-183	Topcare Ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-183	Topcare Ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-183	Topcare Ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-517	Topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-517	Topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-517	Topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
37012-074	Ibuprofen	Ibuprofen	Shopko Stores Operating Co., LLC	ANDA	Current
37012-074	Ibuprofen	Ibuprofen	Shopko Stores Operating Co., LLC	ANDA	Current
37808-709	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-709	Ibuprofen	Ibuprofen	H E B	ANDA	Current
41190-517	ShopRite Ibuprofen IB	Ibuprofen	Wakefern Food Corporation	ANDA	Current
41250-074	ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41520-495	CareOne Ibuprofen	Ibuprofen	American Sales Company	ANDA	Current
41520-695	CareOne Ibuprofen	Ibuprofen	American Sales Company	ANDA	Current
49035-517	Equate Ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-517	Equate Ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49348-727	sunmark ibuprofen ib	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-727	sunmark ibuprofen ib	Ibuprofen	McKesson	ANDA	Current
49348-727	sunmark ibuprofen ib	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-927	Sunmark ibuprofen ib	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-927	Sunmark ibuprofen ib	Ibuprofen	McKesson	ANDA	Current
49348-927	Sunmark ibuprofen ib	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49738-517	smart sense ibuprofen	Ibuprofen	Kmart Corporation	ANDA	Current
49738-517	smart sense ibuprofen	Ibuprofen	Kmart Corporation	ANDA	Current
50269-000	MOTRIN IB	IBUPROFEN	JC World Bell Wholesale Co., Inc.	ANDA	Current
50269-000	MOTRIN IB	IBUPROFEN	JC World Bell Wholesale Co., Inc.	ANDA	Current
50269-000	MOTRIN IB	IBUPROFEN	JC World Bell Wholesale Co., Inc.	ANDA	Current
50269-000	MOTRIN IB	IBUPROFEN	JC World Bell Wholesale Co., Inc.	ANDA	Current
50580-230	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50580-230	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50580-230	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50580-230	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50580-230	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50580-230	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50580-230	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50594-005	sound body ibuprofen	Ibuprofen	Big Lots Stores, Inc.	ANDA	Current
50594-005	sound body ibuprofen	Ibuprofen	Big Lots Stores, Inc.	ANDA	Current
52904-947	Motrin IB	ibuprofen	Select Corporation	ANDA	Current
55316-517	Healthy Accents ibuprofen	Ibuprofen	DZA Brands LLC	ANDA	Current
55319-517	family wellness ibuprofen ib	Ibuprofen	Family Dollar Services Inc	ANDA	Current
55910-074	DG Health Ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-074	DG Health Ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-074	DG Health Ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-074	DG Health Ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-074	DG Health Ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-517	rexall ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-517	rexall ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-517	rexall ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current
55910-758	dg health ibuprofen	Ibuprofen	Dolgencorp Inc	ANDA	Current