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 47 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Childrens	IBUPROFEN	H E B	0a9a54ce-572f-4a96-922f-cc136d2d4aad	2018-06-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Breeden Brothers, LLC	e4314153-479d-4c0f-ba49-4d4efded304b	2018-04-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	acc4cbc8-085d-42f3-ad93-113e0b55631c	2017-11-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS PHARMACY, INC.	cdd5a402-df90-4a16-a38c-78eab7189998	2017-11-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Fast Pain Relief	IBUPROFEN	HealthLife of USA LLC	a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65	2017-06-05	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Ibuprofen	IBUPROFEN	Breeden Brothers, LLC	ba106f6f-2c6b-4c98-a10e-d27622b08b25	2017-02-15	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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