Application 070081

Type: ANDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	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
A070081-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL			1986-06-16

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	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070081-001	IBUPROFEN	400MG	TABLET / ORAL	1986-06-16	`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 27 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	32f86bfb-67a6-49b5-a90a-5197f0d1baba	2025-05-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	DISCOUNT DRUG MART	9998b851-825b-a97d-e053-2a95a90affc6	2025-05-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	DISCOUNT DRUG MART	999902da-4850-68ab-e053-2a95a90a82ea	2025-05-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	3520deb7-5e45-3d0f-e063-6394a90ab44b	2025-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
profen ib	IBUPROFEN	Publix Super Markets Inc	51fbfd25-3c4d-4de1-8fa2-e5b4b24022f2	2025-05-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	230914e6-fe0c-45be-8b2e-e066c71d004c	2025-05-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
good sense ibuprofen childrens	IBUPROFEN	L. Perrigo Company	b8e3ad4f-3212-4674-bcdf-a60a6b23d7bb	2025-05-12	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Meijer Distribution Inc	3b15dc44-ae1d-43c6-b6c5-05fa31beb554	2025-05-12	Warnings	Name fallback generic name: IBUPROFEN
Up and Up childrens ibuprofen	IBUPROFEN	Target Corporation	28911692-882b-4e30-ba1d-5c10f847be80	2025-05-12	Warnings	Name fallback generic name: IBUPROFEN
Equaline Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	c611afc0-5cde-4f01-908a-de52cb61ab02	2025-05-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AAFES/Your Military Exchanges	773b0230-a3a3-44e0-a22b-d143796ca365	2025-05-08	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Equaline ibuprofen childrens	IBUPROFEN	United Natural Foods, Inc. dba UNFI	811d4360-7468-4ef8-a60e-6e9a6e169de0	2025-05-08	Warnings	Name fallback generic name: IBUPROFEN
Good Sense Childrens Ibuprofen	IBUPROFEN	L. Perrigo Company	a8fc1b0c-dd69-4567-8eea-de4d9b0c7740	2025-05-07	Warnings	Name fallback generic name: IBUPROFEN
foster and thrive childrens ibuprofen ib	IBUPROFEN	Strategic Sourcing Services LLC	37adf659-9a92-428b-ac99-5718f242a4e9	2025-05-07	Warnings	Name fallback generic name: IBUPROFEN
up and up ibuprofen	IBUPROFEN	Target Corporation	6e0330ac-a111-4574-9197-d7aab33b8608	2025-05-07	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Meijer Distribution Inc	66b19ed1-6cf9-4705-82cd-02f23c6379e7	2025-05-06	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
equaline ibuprofen childrens	IBUPROFEN	United Natural Foods, Inc. dba UNFI	835c3bc8-fb55-4b7e-98ad-3d84d089c8cb	2025-05-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	34673d3b-41cd-f4c9-e063-6394a90a8510	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3467b45b-c432-2923-e063-6394a90a1044	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Major Pharmaceuticals	b4962985-47e6-4389-874f-76742b086e2f	2025-05-03	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.