Application 091355

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	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
A091355-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-04-04

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	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	NUVICARE LLC	b063d2dc-d579-46e7-8cfc-1596c803c7f9	2026-07-29	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355
Ibuprofen	IBUPROFEN	Pioneer Life Sciences, LLC	291602fa-8ebe-4200-bba7-9798c90f8a50	2026-07-29	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	2024-05-23	Boxed warning, Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355 ndc (product): 59556-856 ndc (product): 59556-855
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc.	1f4159ad-d58c-4519-932b-030cc2735514	2017-05-26	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355 ndc (product): 59556-856 ndc (product): 59556-855

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
41163-212	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
41163-711	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
49738-112	Ibuprofen	Ibuprofen	SMART SENSE (KMART)	ANDA	Current
49738-510	Ibuprofen	Ibuprofen	SMART SENSE (KMART)	ANDA	Current
49738-510	Ibuprofen	Ibuprofen	SMART SENSE (KMART)	ANDA	Current
57344-111	Ibuprofen	Ibuprofen	AAA Pharmaceutical, Inc.	ANDA	Current
57344-111	Ibuprofen	Ibuprofen	AAA Pharmaceutical, Inc.	ANDA	Current
57344-112	Ibuprofen	Ibuprofen	AAA Pharmaceutical, Inc.	ANDA	Current
57344-112	Ibuprofen	Ibuprofen	AAA Pharmaceutical, Inc.	ANDA	Current
57910-400	Ibuprofen	Ibuprofen	Shasun Pharmaceuticals Limited	ANDA	Current
57910-402	Ibuprofen	Ibuprofen	Shasun Pharmaceuticals Limited	ANDA	Current
59556-855	Ibuprofen	Ibuprofen	Strides Pharma Inc.	ANDA	Current
59556-855	Ibuprofen	Ibuprofen	Strides Pharma Inc	ANDA	Current
59556-856	Ibuprofen	Ibuprofen	Strides Pharma Inc.	ANDA	Current
59556-856	Ibuprofen	Ibuprofen	Strides Pharma Inc	ANDA	Current
61715-018	Ibuprofen	Ibuprofen	Kinray	ANDA	Current
63868-790	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
63868-790	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
63868-791	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
63868-791	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
63868-793	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
63868-793	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
63868-794	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
63868-794	Ibuprofen IB	Ibuprofen	Chain Drug Marketing Association	ANDA	Current
67091-129	Ibuprofen IB	Ibuprofen	WinCo Foods, LLC	ANDA	Current
67091-129	Ibuprofen IB	Ibuprofen	WinCo Foods, LLC	ANDA	Current
67091-130	Ibuprofen IB	Ibuprofen	WinCo Foods, LLC	ANDA	Current
67091-130	Ibuprofen IB	Ibuprofen	WinCo Foods, LLC	ANDA	Current
68210-4200	Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4200	Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68998-111	Ibuprofen	Ibuprofen	Marc Glassman, Inc.	ANDA	Current
68998-111	Ibuprofen	Ibuprofen	Marc Glassman, Inc.	ANDA	Current
68998-112	Ibuprofen	Ibuprofen	Marc Glassman, Inc.	ANDA	Current
68998-112	Ibuprofen	Ibuprofen	Marc Glassman, Inc.	ANDA	Current
69168-338	Ibuprofen	Ibuprofen 200 mg	Allegiant Health	ANDA	Current
72036-111	Ibuprofen	Ibuprofen	Harris Teeter	ANDA	Current
72036-112	Ibuprofen	Ibuprofen	Harris Teeter	ANDA	Current