Application 203599

Type: ANDA
Sponsor: SOFGEN PHARMS

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 1.

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
A203599-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2016-09-07

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203599-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-09-07	`cb3db0bc1861…`

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	74f46147-b4c2-4bb3-bd0a-220c0a5403a6	2025-04-01	Warnings	Exact identifier application applno (ANDA): 203599 application number: ANDA203599 ndc (product): 55910-513
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	0cb4b0ef-5cdd-4c79-8718-4fb157a2c948	2025-03-29	Warnings	Exact identifier application applno (ANDA): 203599 application number: ANDA203599 ndc (product): 0113-4501
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	3b78c004-e4fe-449c-86e9-52e8ccf12785	2025-03-25	Warnings	Exact identifier application applno (ANDA): 203599 application number: ANDA203599 ndc (product): 0113-0298
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	25bc5cc2-9b6a-47e4-8b3d-2bb370907b61	2025-03-20	Warnings	Exact identifier application applno (ANDA): 203599 application number: ANDA203599 ndc (product): 72288-500
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	cd15159a-9ed5-453a-9ad4-0c9688204c82	2025-03-19	Warnings	Exact identifier application applno (ANDA): 203599 application number: ANDA203599 ndc (product): 72288-131

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0298	good sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0298	good sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0298	good sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0298	good sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-0298	good sense ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-4501	good sense ibuprofen	ibuprofen	L. Perrigo Company	ANDA	Current
0113-4501	good sense ibuprofen	ibuprofen	L. Perrigo Company	ANDA	Current
0113-7131	basic care ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
0113-7131	basic care ibuprofen	Ibuprofen	L. Perrigo Company	ANDA	Current
10202-131	7 select ibuprofen	Ibuprofen	7-Eleven	ANDA	Current
10202-131	7 select ibuprofen	Ibuprofen	7-Eleven	ANDA	Current
11673-514	up and up ibuprofen	Ibuprofen	Target Corporation	ANDA	Current
11673-514	up and up ibuprofen	Ibuprofen	Target Corporation	ANDA	Current
11673-514	up and up ibuprofen	Ibuprofen	Target Corporation	ANDA	Current
11822-0131	ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0131	ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0131	ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0131	ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
36800-287	topcare ibuprofen	ibuprofen	Topco Associates LLC	ANDA	Current
36800-287	topcare ibuprofen	ibuprofen	Topco Associates LLC	ANDA	Current
36800-623	topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-623	topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-705	topcare ibuprofen	ibuprofen	Topco Associates LLC	ANDA	Current
36800-705	topcare ibuprofen	ibuprofen	Topco Associates LLC	ANDA	Current
36800-753	topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-753	topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
36800-753	topcare ibuprofen	Ibuprofen	Topco Associates LLC	ANDA	Current
55910-513	dg health ibuprofen	ibuprofen	Dolgencorp Inc	ANDA	Current
55910-513	dg health ibuprofen	ibuprofen	Dolgencorp Inc	ANDA	Current
56062-033	ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
56062-033	ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
56062-033	ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
56062-131	Ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
56062-131	Ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
56062-131	Ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
68391-131	Berkley and Jensen Ibuprofen	Ibuprofen	BJWC	ANDA	Current
68391-131	Berkley and Jensen Ibuprofen	Ibuprofen	BJWC	ANDA	Current
69842-701	ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-701	ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
72288-131	basic care ibuprofen	Ibuprofen	Amazon.com Services LLC	ANDA	Current
72288-131	basic care ibuprofen	Ibuprofen	Amazon.com Services LLC	ANDA	Current
72288-131	basic care ibuprofen	Ibuprofen	Amazon.com Services Inc.	ANDA	Current
72288-500	basic care ibuprofen	ibuprofen	Amazon.com Services LLC	ANDA	Current
72288-500	basic care ibuprofen	ibuprofen	Amazon.com Services LLC	ANDA	Current
81522-131	Caring mill ibuprofen	Ibuprofen	FSA Store Inc.	ANDA	Current
81522-131	Caring mill ibuprofen	Ibuprofen	FSA Store Inc.	ANDA	Current