Application 075367

Type: ANDA
Sponsor: L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JUNIOR STRENGTH IBUPROFEN	IBUPROFEN	TABLET;ORAL	100MG	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
A075367-001	JUNIOR STRENGTH IBUPROFEN	IBUPROFEN	100MG	TABLET / ORAL			1999-04-22

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	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075367-001	JUNIOR STRENGTH IBUPROFEN	100MG	TABLET / ORAL	1999-04-22	`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 46 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 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 generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PURACAP PHARMACEUTICAL LLC	9e86b6e5-5374-4699-a0d1-a4c3d069f262	2020-01-17	Warnings	Name fallback 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 generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	40501966-419a-4ccd-b7c9-5581cbe47a97	2019-12-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	b6e14f73-1f19-4cfa-8858-136a38ee32d0	2019-12-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	67e09ad5-e010-4aa1-b86e-9b22331bf33b	2019-12-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	24ef6819-f098-4d01-bfe7-6ffa4aa0e671	2019-12-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	50bab3b2-f710-46ff-96cd-1ec4d4658529	2019-11-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	f42506f7-896c-47a9-a4b1-ed72434d7aa0	2019-11-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	58bff8bf-5a4e-4390-9c03-e266d31deb6b	2019-11-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	daf579dc-91d1-4950-b637-c1a34f5542c5	2019-11-22	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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