Application 200457

Type: ANDA
Sponsor: ARISE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	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
A200457-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2011-08-18

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 · 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	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`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 25 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare ibuprofen	IBUPROFEN	Topco Associates LLC	479a0c97-dbd9-47ad-9910-9dd4edf5136f	2025-07-02	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS Pharmacy	e241ca5f-04bd-4bc9-bd0c-ca22841c4a3c	2025-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	37eaa3b1-98e9-4fcf-ae74-153bfc35551f	2025-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	7b2f7a68-8f5e-a340-e053-2991aa0a5aeb	2025-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fecb3a8-d288-cacf-e053-2a95a90ae238	2025-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fed1f86-49a0-4747-e053-2a95a90a42b8	2025-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chain Drug Consortium, LLC	f0f01b97-e52c-4077-a4c6-c59736f4c171	2025-06-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	388e68dc-1822-f375-e063-6294a90a3d41	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
JUNIOR STRENGTH ADVIL	IBUPROFEN	Haleon US Holdings LLC	07d4c400-b182-92f7-7574-9e0e94c39cce	2025-06-27	Warnings	Name fallback generic name: IBUPROFEN
leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	009dde4c-d944-4206-8c9f-35bc8fd92715	2025-06-26	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Childrens	IBUPROFEN	Kroger Company	47a3b118-614d-405d-b80e-31f0b354c430	2025-06-25	Warnings	Name fallback generic name: IBUPROFEN
Good Neighbor Pharmacy Childrens Ibuprofen	IBUPROFEN	Amerisource Bergen	40a6a842-a85b-4e24-8786-32ecd74f6870	2025-06-25	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Safeway	1b7854d6-32b9-4410-bb40-0f02e46c7966	2025-06-24	Warnings	Name fallback generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Morning Star OTC	e69f00c4-b8ec-4a83-9eea-8cb2835ad776	2025-06-19	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	AAA Pharmaceutical, Inc.	1e686091-6456-36c8-e063-6294a90a3866	2025-06-17	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	78cf5df8-392b-4a4e-b424-af765a6defdf	2025-06-17	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	FSA STORE INC.	ec6b015d-e72e-89c4-e053-2a95a90af81c	2025-06-17	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Topcare Ibuprofen	IBUPROFEN	Topco Associates LLC	8be375b0-c729-49de-abc5-2e7d37144b89	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	08d9477e-3033-4b74-8f81-934f39e37e55	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN
equaline ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	9bf3546a-9f94-47b5-9b01-aed93e69d5aa	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-672	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals	ANDA	Current