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 32 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	59c77fd3-5e67-45ec-82ad-44585390c4f3	2024-12-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	2810122e-3c89-49a2-8dac-db3714cb7b45	2024-12-30	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	a96d012e-b132-4e99-b84b-ccd3a9a05cbb	2024-12-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Cabinet Pain Reliever and Fever Reducer	IBUPROFEN	Spirit Pharmaceutical LLC	e172a8d8-779d-4ad9-b6b0-08a198a58034	2024-12-30	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	09bd3935-526d-4ad1-898a-4f0d9499ebb9	2024-12-26	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Chain Drug Marketing Association, Inc.	f0959369-890e-403e-8a98-4eda340a0783	2024-12-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	9a93d4a8-07a1-4ac5-9bd9-5d5e4e62c2af	2024-12-20	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc.	5398f5b7-a9a6-4f7e-a06c-e524b9939562	2024-12-19	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fe939219-d752-63a0-e053-6394a90a0ab2	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Quality Care Products, LLC	246b120e-3458-4721-bf95-82537feaa131	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Quality Care Products, LLC	56f1d6a9-6804-4235-a600-f7c8e458f693	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	f4d6372a-d560-0e14-e053-2a95a90a435a	2024-12-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Spirit Pharmaceuticals LLC	e38d23e5-b455-41b5-86f6-c318b17bd345	2024-12-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	a6d4ceb0-2b79-496a-aa1e-27edd507ced0	2024-12-10	Warnings	Name fallback generic name: IBUPROFEN
Assured Ibuprofen	IBUPROFEN	Spirit Pharmaceuticals LLC	119263b5-c3b7-46dc-a3bd-9893bfd24628	2024-12-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	39e55ec1-213f-4996-adca-68a5ffbc409b	2024-12-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Winco Foods, LLC	428b011f-d7d3-4a3b-87dd-d4e84e90cabd	2024-12-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Winco Foods, LLC	61cd9140-eded-4bcf-894b-a163fa5f3e10	2024-12-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Winco Foods, LLC	60130bdc-6f45-4998-b53a-cad6cbf25036	2024-12-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	SOLA Pharmaceuticals, LLC	b19b8c34-e0c1-4982-92fc-34dbe7384935	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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