Application 076741

Type: ANDA
Sponsor: LNK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	100MG	No	No

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
A076741-001	IBUPROFEN	IBUPROFEN	100MG	TABLET / ORAL			2004-06-17

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076741-001	IBUPROFEN	100MG	TABLET / ORAL	2004-06-17	`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 13 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	42b6faf5-ef47-6a7a-e063-6394a90ac409	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	HyVee Inc	4c24c884-55f7-40b4-8d6f-db6144d5ebcb	2026-02-05	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
CareOne Ibuprofen	IBUPROFEN	American Sales Company	03cdff8a-8890-440d-82b5-54ce809f88cc	2026-02-03	Warnings	Name fallback generic name: IBUPROFEN
Pain Relief Ibuprofen	IBUPROFEN	Rite Aid Corporation	c85c3d1f-7639-4cfa-bf3a-424b61757b1a	2026-02-03	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	HyVee Inc	5233c409-3743-4312-9f75-14ded6755b5c	2026-02-02	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
pain relief ibuprofen	IBUPROFEN	Rite Aid Corporation	2bd1438e-27b1-81ff-f8e1-0f5b50b04581	2026-02-02	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	8b5eec38-bdf3-4f27-802f-f4c732ae5c7d	2026-02-02	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	H E B	88c7486b-f9a7-4856-a25a-7c06e1382f1a	2026-02-02	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Strategic Sourcing Services, LLC	dc469eb2-89cc-46c9-9304-f6cf119c0570	2026-01-29	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Caldolor	IBUPROFEN	Cumberland Pharmaceuticals Inc.	1eaa7790-f1a1-4f51-b10a-cbbaf033f684	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Softgel Healthcare Private Limited	2b07ace6-6766-0a06-e063-6294a90ad1bd	2026-01-27	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	847758ed-66fc-4db9-8fdb-78f3c3291a03	2026-01-26	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS Pharmacy	8d9f11a5-ca98-4280-9c6a-093d32e60ace	2026-01-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	b29034a6-657b-426f-a41a-5e64c4bc759d	2026-01-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	70e191ef-8fad-49eb-9850-fceea119e92f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	b84ea215-e61d-4c00-8a34-d47c4080779b	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	WALGREENS	40a1e525-fb1e-08f4-e063-6294a90adfa7	2026-01-14	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	82e907e6-86a9-5c7f-93bd-a6319d74100f	2026-01-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HYVEE INC	45aead8a-37ee-9a66-e063-6394a90a5d17	2026-01-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HYVEE INC	459fc063-0664-09b7-e063-6394a90a89e0	2026-01-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.