Application 209207

Type: ANDA
Sponsor: TARO

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 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
A209207-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2017-06-27

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	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	HF Acquisition Co LLC, DBA HealthFirst	574b6f15-70bc-fca7-e063-6294a90a0455	2026-07-23	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	32edaf34-046e-4ded-8bee-493a0019d6bd	2026-03-25	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 68788-8288
Ibuprofen	IBUPROFEN	EQUATE (WAL-MART STORES, INC.)	104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	2025-08-06	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 49035-693
Childrens Ibuprofen	IBUPROFEN	Kroger Company	91da5b64-db7f-4954-89e8-977b31247f9c	2025-07-11	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 30142-965
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d	2025-07-11	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 11822-9998
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	6cf3328b-da8f-4f6b-8237-16a4d6b9c833	2025-07-07	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 51672-2144
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	f4dad3d6-1366-4bdf-99eb-370ab74a6b9e	2025-07-07	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 51672-2130
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b87cf806-1635-44d5-a9de-383081cb37d8	2024-10-14	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Ibuprofen	IBUPROFEN	Proficient Rx LP	b7565aac-a928-4116-b9af-cf636da4537c	2022-07-01	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 71205-213

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11673-349	Childrens Ibuprofen	Ibuprofen	TARGET Corporation	ANDA	Current
11822-9998	Childrens Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
30142-965	Childrens Ibuprofen	Ibuprofen	Kroger Company	ANDA	Current
49035-693	Ibuprofen	Ibuprofen	EQUATE (WAL-MART STORES, INC.)	ANDA	Current
49035-693	Ibuprofen	Ibuprofen	EQUATE (WAL-MART STORES, INC.)	ANDA	Current
51672-2130	Ibuprofen	Ibuprofen	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2130	Ibuprofen	Ibuprofen	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2138	Ibuprofen	Ibuprofen	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2144	Ibuprofen	Ibuprofen	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55319-150	Childrens Ibuprofen	Ibuprofen	FAMILY WELLNESS	ANDA	Current
55319-150	Childrens Ibuprofen	Ibuprofen	FAMILY WELLNESS	ANDA	Current
67091-321	Ibuprofen	Ibuprofen	WinCo Foods, LLC	ANDA	Current
68788-8288	Ibuprofen	Ibuprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-213	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
71205-213	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
71205-213	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current