Application 075217

Type: ANDA
Sponsor: L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION/DROPS;ORAL	40MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075217-001	IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL			1998-12-16

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3a93d1ddd44b…`

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leader infants ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	b72fdf65-8112-4d8b-b86f-8e17a40ee8e6	2025-04-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217 ndc (product): 70000-0298
equaline ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	ea2ba726-0199-42ae-9c60-4b068df35e64	2025-04-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	19d3af1c-9dd5-48d9-bd5c-05cc8745e836	2025-01-04	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Foster and Thrive Infants Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	fe3092af-9a7b-4189-af89-31be8d6fed53	2024-07-12	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Topcare Ibuprofen	IBUPROFEN	Topco Associates LLC	742f33fa-8923-4415-bcd6-8db37f2e1974	2023-01-06	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
infants ibuprofen	IBUPROFEN	H E B	2c67fecb-2e69-44d6-8ab8-3251abae72a6	2021-11-16	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
basic care infants ibuprofen	IBUPROFEN	Amazon.com Services LLC	1b5b96cc-40d4-4fb8-b429-cc1a5076fa77	2021-10-08	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217 ndc (product): 72288-057
basic care infants ibuprofen	IBUPROFEN	Amazon.com Services LLC	581dca08-a4a4-476a-a7cf-fa0f8630c777	2021-05-04	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217 ndc (product): 72288-255

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69256-057	Harris Teeter Ibuprofen	ibuprofen	Harris Teeter, LLC	ANDA	Current
69256-255	Harris Teeter Ibuprofen	Ibuprofen	Harris Teeter, LLC	ANDA	Current
70000-0298	leader infants ibuprofen	Ibuprofen	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0298	leader infants ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
70000-0307	leader ibuprofen	ibuprofen	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0307	leader ibuprofen	ibuprofen	Cardinal Health	ANDA	Current
72288-057	basic care infants ibuprofen	ibuprofen	Amazon.com Services LLC	ANDA	Current
72288-255	basic care infants ibuprofen	Ibuprofen	Amazon.com Services LLC	ANDA	Current
76413-312	Ibuprofen	ibuprofen	Central Texas Community Health Centers	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42960	ORIG	1998-12-16
39466	ORIG	1998-12-16
8567	ORIG	1998-12-16