Application 208865

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A208865-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2017-11-08

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	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMAZON BASIC CARE IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	113dd693-6abe-1a0f-e063-6394a90a167e	2025-06-06	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865
Ibuprofen	IBUPROFEN	Aurohealth LLC	09bd3935-526d-4ad1-898a-4f0d9499ebb9	2024-12-26	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865 ndc (product): 58602-708
Ibuprofen	IBUPROFEN	Aurohealth LLC	1100648c-6b9f-49c9-94d0-c40f24fe5c27	2022-03-23	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865 ndc (product): 58602-713
Ibuprofen	IBUPROFEN	Aurohealth LLC	0ade8ee2-7c74-4b05-925e-d92742fc2b90	2022-03-03	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865 ndc (product): 58602-801
Ibuprofen	IBUPROFEN	Aurohealth LLC	cf6fbf3b-a0f3-4e08-a981-d183fa285758	2022-03-03	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865 ndc (product): 58602-802

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58602-708	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-713	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-801	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-801	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-801	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-802	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-802	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-802	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current