Application 077114

Type: ANDA
Sponsor: PERRIGO PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No
002	IBUPROFEN	IBUPROFEN	TABLET;ORAL	600MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077114-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18
A077114-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18
A077114-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18

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 4 · 129 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	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077114-002	IBUPROFEN	600MG	TABLET / ORAL	2005-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077114-003	IBUPROFEN	800MG	TABLET / ORAL	2005-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077114-001	IBUPROFEN	400MG	TABLET / ORAL	2005-07-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077114-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077114-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077114-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077114-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077114-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077114-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077114-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077114-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077114-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077114-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077114-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077114-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077114-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077114-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077114-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077114-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077114-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077114-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077114-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077114-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077114-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077114-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077114-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077114-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077114-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077114-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077114-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077114-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077114-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077114-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077114-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077114-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077114-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077114-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077114-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077114-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077114-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077114-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077114-003	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A077114-001	AB	1	`e64feba35796…`

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 45 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	77adb094-869c-44b4-8a4e-b739ac9cd701	2021-04-20		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd	2021-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Proficient Rx LP	924d2dd0-3b7d-42ec-b617-86729dba2b95	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	8813a8a4-ebbd-4204-88a3-600a92ea9170	2020-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	CVS Pharmacy	60fd517d-608b-473e-8a44-eb9842459997	2020-10-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen IB	IBUPROFEN	WINCO FOODS, LLC	9d78644d-83c7-46d1-8156-0d76acb7c299	2020-09-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen IB	IBUPROFEN	WINCO FOODS, LLC	ee867519-227f-44ba-ba8b-2dbefcc9fc67	2020-09-17	Warnings	Name fallback generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	18e5eed7-d3be-4559-93ca-b40ee26c7bd8	2020-09-09	Warnings	Name fallback generic name: IBUPROFEN
Basic Care Childrens Ibuprofen	IBUPROFEN	Amazon.com Services LLC	d53cb3f1-6689-40dd-bdea-fad3a841d482	2020-09-03	Warnings	Name fallback generic name: IBUPROFEN
Dolex Children	IBUPROFEN	Pharmadel LLC	ac3c264f-da37-a474-e053-2a95a90abdad	2020-08-06	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Bryant Ranch Prepack	6d189e86-4c36-43f5-b406-a342458d4155	2020-05-27		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	af68a4bf-bc49-40c7-812d-035eff474ed9	2020-04-03	Warnings	Name fallback generic name: IBUPROFEN
JUNIOR STRENGTH ADVIL	IBUPROFEN	Proficient Rx LP	91fc4794-1880-460f-86dd-49d8c1e872bc	2020-03-01	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Proficient Rx LP	6d84ed87-b643-46e2-96d4-2052f41bd936	2020-02-01	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PURACAP PHARMACEUTICAL LLC	9e86b6e5-5374-4699-a0d1-a4c3d069f262	2020-01-17	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	H E B	e7e2b766-6d05-49e2-9e88-72454b857935	2019-12-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	73eb763e-ce21-4cff-854f-3297f20f1f61	2019-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	40501966-419a-4ccd-b7c9-5581cbe47a97	2019-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	b6e14f73-1f19-4cfa-8858-136a38ee32d0	2019-12-10	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.