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 15 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	Northwind Health Company, LLC	da6c2802-5d15-dbcb-e053-2a95a90a2561	2026-01-01	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Savings Distributors LLC	56846774-8413-c306-e063-6394a90a2be8	2026-01-01	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES, INC	e0a8315a-80a5-4be3-aad1-3d01f00df494	2025-12-29	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension Original Berry Flavor	IBUPROFEN	Puro Pharma Inc.	6b993b25-9c81-4d75-b332-6de3f6c3b4c9	2025-12-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	a8b46ae5-67bc-494d-850e-b4e4ed5a33b3	2025-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	f2a08223-a73a-5461-e053-2995a90a3bce	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	ab074ae8-5696-5327-e053-2a95a90a7ce3	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	AptaPharma Inc.	40936019-74ab-4b25-a502-7bbc6e12034a	2025-12-26	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen Grape	IBUPROFEN	AptaPharma Inc.	7caca7e2-6652-45fc-9538-275b43a1594e	2025-12-26	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	46a9424c-fd7d-f88b-e063-6294a90abceb	2025-12-24	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Lil Drug Store Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	29190ebf-bb9c-4406-be7b-4427741aeb74	2025-12-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS	10424ad8-74fc-4f5f-e063-6394a90a13bd	2025-12-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
good sense ibuprofen childrens	IBUPROFEN	Preferred Pharmaceuticals Inc.	7ac61180-d668-4eec-b04f-d14f7b552a4d	2025-12-23	Warnings	Name fallback generic name: IBUPROFEN
Motrin IB Migraine	IBUPROFEN	Kenvue Brands LLC	34818110-5291-4bda-9571-bd77d90bba7c	2025-12-22	Warnings	Name fallback generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Kenvue Brands LLC	d9fc716a-fba5-45f8-8024-52325799d1dd	2025-12-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Granules USA, Inc.	8cb595d2-b7c2-687d-e053-2a95a90a5720	2025-12-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Retail Business Services, LLC	04115ec1-ef31-1746-e063-6394a90a0a52	2025-12-19	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES,LLC.	a567dc6f-bd83-b9f5-e053-2995a90a05ee	2025-12-19	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES,LLC.	a568fd1e-9bf0-3c03-e053-2a95a90a45b7	2025-12-19	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TOPCO ASSOCIATES LLC	1a00c17f-9766-deaa-e063-6394a90a8d60	2025-12-19	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.