Application 204469

Type: ANDA
Sponsor: STRIDES PHARMA

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
A204469-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2018-03-28

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	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	faabb11a-6fa0-492d-85cc-74ff8175b0b3	2026-07-01	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
Basic Care Ibuprofen	IBUPROFEN	Amazon.com Services LLC	4c1a1543-a2a2-43fb-901c-cf6bcc374a3f	2026-06-03	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
BASIC CARE IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	ae50a548-dc32-4c5b-b133-c6537267127b	2026-03-11	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
IBUPROFEN	IBUPROFEN	Strides Pharma Inc	69b208ff-83f5-40d1-a2ff-d54b390e46e4	2026-01-08	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469 ndc (product): 59556-764 ndc (product): 59556-895
DG Health Ibuprofen	IBUPROFEN	Dolgencorp Inc	1dd4ffc5-3132-419b-8e70-78a7bb71da62	2026-01-02	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
Foster and Thrive Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	cf330b44-2d69-4f9f-99eb-2caa80aca873	2025-07-08	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59556-764	IBUPROFEN	IBUPROFEN	Strides Pharma Inc	ANDA	Current
59556-764	IBUPROFEN	IBUPROFEN	Strides Pharma Inc	ANDA	Current
59556-895	IBUPROFEN	IBUPROFEN	Strides Pharma Inc	ANDA	Current
68210-4205	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-4205	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current