Application 071667

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	600MG	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
A071667-001	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL			1987-06-18

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	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071667-001	IBUPROFEN	600MG	TABLET / ORAL	1987-06-18	`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 9 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	88dda062-2b9c-3632-e053-2a95a90a1431	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	bdc3f482-6fba-4420-9118-0f5cb7744e97	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals, Inc.	72ec2491-924d-460f-9510-62d624d54b59	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	60c731c6-4dc4-490a-8469-0b7e58e563a1	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	13fd4401-1821-4f2b-a44e-96aa2fa75b5c	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	f1a03b1f-2d87-43cc-b256-bd296ccd09f2	2026-05-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	25d9f5fc-4d95-4018-add8-ba696b6079b2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Motrin Infants	IBUPROFEN	Kenvue Brands LLC	c57f6ded-c0bd-45ae-823a-4c02ce334d98	2026-05-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	QPharma Inc	fd8b82a7-96fe-8bf5-e053-6394a90a3935	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	CVS Pharmacy	a6fc144a-6826-4bf7-8efb-8cdb896387f1	2026-05-12	Warnings	Name fallback generic name: IBUPROFEN
Good Sense Infants Ibuprofen	IBUPROFEN	L. Perrigo Company	3d2fa7ad-1574-4c79-959d-3ee284468a99	2026-05-11	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension Dye free	IBUPROFEN	AptaPharma Inc.	bb995c57-a2cc-4bc7-9c7d-f885c425be64	2026-05-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	05ce8e8e-0b25-061e-e063-6394a90a2e92	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen infants	IBUPROFEN	H E B	e353bc69-c03e-4bae-a357-f7f3fab91695	2026-05-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Granules Pharmaceuticals Inc.	4aefcb3a-5dc8-b88e-e063-6294a90ac044	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	H E B	4805977f-a30b-4f86-9ef5-e66ad6b8bd53	2026-05-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	4a0c744f-4ad8-445e-bab1-7ffee35bf861	2026-05-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
infants dye free ibuprofen	IBUPROFEN	Kroger Company	6dc009c8-5b44-4d53-b053-eaed2223d975	2026-05-05	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Kroger Company	6307485a-8be6-40ee-899b-00eb3ee8ce61	2026-05-01	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	St. Mary's Medical Park Pharmacy	95830141-2439-9d45-e053-2995a90ae084	2026-05-01		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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