Application 202300

Type: ANDA
Sponsor: AMNEAL 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 42.

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
A202300-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2011-12-23

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Pain Reliever/Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals LLC	877440fc-3afb-4123-a2e6-5cb48c74413c	2024-10-25	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300 ndc (product): 65162-356
Ibuprofen Pain Reliever/Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals LLC	5f27dd3f-c735-417b-95e6-26dc5aae5a7a	2024-10-25	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300 ndc (product): 65162-770
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7d544d8e-fa76-461f-9417-5f1873912eac	2023-05-15	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300 ndc (product): 55910-830
Ibuprofen	IBUPROFEN	P & L Development, LLC	1889faea-24a3-45ea-92de-8dc76b9ed5b4	2023-04-25	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30142-121	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
30142-122	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
30142-123	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
37808-221	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-221	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-221	Ibuprofen	Ibuprofen	H E B	ANDA	Current
41250-221	Ibuprofen	Ibuprofen	MEIJER, INC.	ANDA	Current
41250-221	Ibuprofen	Ibuprofen	MEIJER, INC.	ANDA	Current
49035-121	Ibuprofen	Ibuprofen	EQUATE (Walmart Stores, Inc.)	ANDA	Current
49035-121	Ibuprofen	Ibuprofen	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
55910-830	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-830	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-830	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
56062-121	Ibuprofen	Ibuprofen	Publix Supermarkets, Inc.	ANDA	Current
56062-121	Ibuprofen	Ibuprofen	Publix Supermarkets, Inc.	ANDA	Current
56062-122	Ibuprofen	Ibuprofen	Publix Supermarkets, Inc.	ANDA	Current
56062-122	Ibuprofen	Ibuprofen	Publix Supermarkets, Inc.	ANDA	Current
63941-121	Ibuprofen	Ibuprofen	Valu Merchandisers Company (Best Choice)	ANDA	Current
63981-121	Ibuprofen	Ibuprofen	Costco Wholesale	ANDA	Current
63981-121	Ibuprofen	Ibuprofen	Costco Wholesale	ANDA	Current
63981-121	Ibuprofen	Ibuprofen	Costco Wholesale	ANDA	Current
65162-356	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-356	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-356	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-356	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-770	Ibuprofen Pain Reliever/Fever Reducer	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-770	Ibuprofen Pain Reliever/Fever Reducer	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-770	Ibuprofen Pain Reliever/Fever Reducer	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-770	Ibuprofen Pain Reliever/Fever Reducer	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
68391-121	Ibuprofen	Ibuprofen	BJWC (Berkley & Jensen / BJ's)	ANDA	Current