Application 217236

Type: ANDA
Sponsor: PATHEON SOFTGELS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT	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
A217236-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2024-02-13

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.

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	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217236-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2024-02-13	`a50c72e98297…`

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 30 of 48 · 948 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	31f61d5c-a3a3-3d47-e063-6394a90afb62	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6005b-492e-7936-e063-6394a90ad801	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6ac7a-fa3e-4dd4-e063-6294a90a29af	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	b303b554-c457-4f2b-9931-48f30943178b	2025-04-03	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	87c9f15f-1196-477c-b5d2-3b875bea61d0	2025-04-03	Warnings	Name fallback generic name: IBUPROFEN
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	74f46147-b4c2-4bb3-bd0a-220c0a5403a6	2025-04-01	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	0cb4b0ef-5cdd-4c79-8718-4fb157a2c948	2025-03-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3140a614-c7ae-3062-e063-6394a90ad3d7	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	3b78c004-e4fe-449c-86e9-52e8ccf12785	2025-03-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	WR Group, Inc.	e9dad35a-6789-42d6-97da-521db7b16496	2025-03-24	Warnings	Name fallback generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	25bc5cc2-9b6a-47e4-8b3d-2bb370907b61	2025-03-20	Warnings	Name fallback generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	cd15159a-9ed5-453a-9ad4-0c9688204c82	2025-03-19	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Care One (Retail Business Services, LLC.)	a6ce7484-7a32-4985-80bc-883c31be3525	2025-03-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
LEADER CHILDRENS IBUPROFEN	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	913a4bd0-0784-45b4-b05e-3e7c016bbb86	2025-03-03	Warnings	Name fallback generic name: IBUPROFEN
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	2daee8c1-d05e-406b-af65-b81bbbaa244d	2025-03-03	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	02889717-204c-463b-8506-4c5cf18c77d3	2025-03-03	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bi-Mart	df8aa8bf-720a-483a-b6d9-e4bf8a2d9440	2025-03-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Discount Drug Mart, Inc	2d58d1c4-b864-6bb8-e063-6394a90a7117	2025-02-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurobindo Pharma Limited	00872852-680a-41b3-901b-b991b12a176d	2025-02-14	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.