Application 207753

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
A207753-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2018-06-29

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	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Aurohealth LLC	43c94480-78d1-4a23-91d4-1d49fea72cb7	2026-06-05	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 58602-852
Ibuprofen	IBUPROFEN	P & L Development, LLC	ce215099-91b0-43fd-8ac9-17fe6508842c	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 59726-046
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	da9d0301-ec14-40c5-b0b9-17096913a849	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 55910-046
Ibuprofen	IBUPROFEN	Better Living Brands LLC	f6ef7f73-b5ab-4c82-e053-6394a90ac81e	2023-09-22	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	RITE AID CORPORATION	de158883-1175-18fc-e053-2995a90a3c96	2023-04-12	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 11822-4258
Ibuprofen	IBUPROFEN	Aurohealth LLC	e1b49257-d226-457f-8f2d-9a757a65bbcb	2022-09-06	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 58602-879
Ibuprofen	IBUPROFEN	Aurohealth LLC	7779c369-50bf-4cde-9015-ff3fb35e128e	2022-05-16	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 58602-843
Ibuprofen	IBUPROFEN	Aurohealth LLC	3b0e77a1-b49d-4c67-81dd-66450dabcf3b	2022-03-04	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 58602-902

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11822-4258	Ibuprofen	Ibuprofen	RITE AID CORPORATION	ANDA	Current
55319-046	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-046	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55910-046	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-046	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
58602-843	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-843	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-843	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-852	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-879	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-902	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-902	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-902	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-902	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
58602-902	Ibuprofen	Ibuprofen	Aurohealth LLC	ANDA	Current
59726-046	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-046	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-046	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-046	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current