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 17 of 48 · 948 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	9c1ded4e-1d3b-1ab6-e053-2995a90aa80d	2025-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	9c1cc205-b9e3-03fc-e053-2995a90aaffb	2025-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Motrin IB, TRAVEL BASIX	IBUPROFEN	Lil' Drug Store Products, Inc.	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	2025-12-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chartwell RX, LLC	39f2664f-6c0a-4726-85d7-4227530d4a49	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	fbc7fb61-d295-464b-9f3b-52262ed6f31a	2025-12-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Migraine	IBUPROFEN	CVS Pharmacy	ce54fc98-5774-4800-e053-2a95a90ad5f7	2025-12-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	45223597-0ea8-b275-e063-6394a90a8412	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522cb9e-4999-c455-e063-6294a90a294f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Strides Pharma Science Limited	a266a3c6-932f-476f-ae93-48a785c92286	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen 572	IBUPROFEN	Family Dollar Services, Inc.	1a2182df-4339-442d-9c61-98c8b01e36fa	2025-12-03	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Family Dollar Services, Inc.	137a0290-822a-842d-e063-6294a90a5c18	2025-12-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Redpharm Drug	44f278ac-6bf9-6aef-e063-6394a90a0bb6	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Redpharm Drug	44f5743f-8c98-dc4d-e063-6294a90a6dfa	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Redpharm Drug	44f609dd-c868-493f-e063-6294a90a7138	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBU	IBUPROFEN	Proficient Rx LP	a7098fa1-b5ae-485e-ada9-64154f81fb6a	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Granules India Limited	8804564c-9e1b-43c1-8b58-fd6ace645f00	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Lil Drug Store Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	c3be5923-9299-49b0-a455-e0c1c86985a8	2025-12-01	Warnings	Name fallback generic name: IBUPROFEN
CAREALL Ibuprofen	IBUPROFEN	New World Imports	246cf64a-162d-47a4-910a-9fb0b9be3dd1	2025-12-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	QPharma, Inc.	f452d2c3-525f-4933-b146-92351d0ae44f	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	71b5b2a2-397e-4dcb-b0c7-ef08df4337e0	2025-11-26	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.