Application 071668

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	800MG	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
A071668-001	IBUPROFEN	IBUPROFEN	800MG	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	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071668-001	IBUPROFEN	800MG	TABLET / ORAL	1987-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071668-001	IBUPROFEN	800MG	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 39 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e872c8d-28e2-cd49-e053-2995a90a469f	2024-01-03	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN 200 MG	IBUPROFEN	Basic Drugs, Inc.	d3351d44-2078-3adc-e053-2995a90a3c8f	2024-01-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	59f14d2b-f48a-4c25-bea3-3dc9100898b2	2023-12-31	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Pain Releiver/ Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	ee241be0-35f8-4789-a71f-98de31d6a590	2023-12-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0	2023-12-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals NY LLC	e07d989d-1b0e-4cc1-abf2-93c8b208a29a	2023-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	DEMOULAS SUPERMARKETS INC.	4ca54293-9e81-4b24-8112-734f28cd2c55	2023-12-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bionpharma Inc.	4bc6e8f2-ba95-4352-80ed-b44608fc4936	2023-12-27	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Dye-Free Ibuprofen	IBUPROFEN	RITE AID CORPORATION	c1c58a2d-9ffd-69d0-e053-2a95a90a5718	2023-12-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	f1f1e0ac-6944-4123-9e08-1df91582d457	2023-12-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8553e29a-7f6f-4ff8-9991-836e619c504d	2023-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	American Health Packaging	bc69d88b-d9af-4010-8e8f-e761a9e295a9	2023-12-05	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	7152b6ce-6113-4003-bf80-aa263be69392	2023-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	400faee1-f662-470e-bcd6-7711dfaf9ba2	2023-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	e210c707-2bae-44a5-93dc-459dd24fd960	2023-11-20	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	c7e59784-a338-4922-a806-98c7505957cd	2023-11-10	Warnings	Name fallback generic name: IBUPROFEN
Concentrated ibuprofen infants	IBUPROFEN	Chain Drug Marketing Association Inc.	c9ae72d8-d205-4736-9bc4-2325cd77d36b	2023-11-03	Warnings	Name fallback generic name: IBUPROFEN
foster and thrive ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	68d67a25-e669-47c7-8410-9f304b914ff1	2023-10-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Geri-Care Pharmaceutical Corp	0744c3ca-4224-4f6a-a033-880949b544fd	2023-10-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC.	059cb22f-f6db-5d03-e063-6294a90a9ec1	2023-10-27	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.