Application 209178

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	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
A209178-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB		2018-02-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209178-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209178-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209178-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209178-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209178-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209178-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209178-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209178-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209178-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209178-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209178-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209178-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209178-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209178-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209178-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209178-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209178-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209178-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209178-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209178-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209178-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209178-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209178-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209178-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209178-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209178-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209178-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209178-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209178-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209178-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209178-001	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN ORAL	Aurobindo Pharma Limited	758eeb45-e599-4c1a-969d-8fa33f27bf14	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209178 application number: ANDA209178 ndc (product): 59651-032
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	141b7964-cce6-74e4-e063-6294a90af746	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209178 application number: ANDA209178

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current
59651-032	Ibuprofen	Ibuprofen Oral	Aurobindo Pharma Limited	ANDA	Current