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 5 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Dr. Reddy's Laboratories Inc.	4d830b9b-b396-9581-7572-c7f19ff17597	2026-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	St. Mary's Medical Park Pharmacy	88dd304f-1c64-08e3-e053-2a95a90a596f	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	faabb11a-6fa0-492d-85cc-74ff8175b0b3	2026-07-01	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Infants Motrin	IBUPROFEN	Kenvue Brands LLC	c2302bfe-b367-4867-b803-29f066a42dc7	2026-06-30	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	1e6f3ce7-e8a3-40e8-8437-523ef5277b2e	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HAWAII REPACK, INC.	6239818c-747d-4cbb-9b41-27ca8bbce41b	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sportpharm LLC	cef04ae4-e78a-454d-bb66-84b1d348c106	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen mini dye free	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	552d9018-cc7e-7e1a-e063-6294a90a3322	2026-06-26	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	fb842f4d-1228-9a52-e053-6294a90adb41	2026-06-26	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	551535ce-eab0-bb13-e063-6294a90a2070	2026-06-25	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	5515661b-6373-2191-e063-6294a90a17e0	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	5515e80f-7513-b425-e063-6294a90aa542	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Mini Dye Free	IBUPROFEN	CVS Pharmacy	42c7dbec-2e53-70ae-e063-6294a90a16e6	2026-06-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b40f39e4-a37c-4039-ae37-210c1c3c6235	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	c62cc12f-5a0e-389a-e053-2995a90a208c	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	c6297c23-3b27-c0c6-e053-2995a90a3e76	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MEIJER DISTRIBUTION INC.	a139e495-3dbf-4998-e053-2a95a90ac136	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
pain relief	IBUPROFEN	Bionpharma Inc.	a14ca126-fada-c903-e053-2995a90ae72d	2026-06-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HEB	ca4be24c-5d92-ddc9-e053-2a95a90aa5a7	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	DOLGENCORP INC	03138a6f-653a-f359-e063-6394a90ac5d6	2026-06-23	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.