Application 077349

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	No	Yes

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
A077349-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL		RS	2005-06-21

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen 200mg	IBUPROFEN 200MG	Allegiant Health	51e95588-39af-40d6-9924-e98d42af15b9	2018-12-31	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349 ndc (product): 69168-390

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 · 120 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
56062-074	ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
56062-074	ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
56062-517	ibuprofen	Ibuprofen	Publix Super Markets Inc	ANDA	Current
59779-074	ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-074	ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-517	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-517	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
62011-0213	Health Mart Ibuprofen IB	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
62011-0213	Health Mart Ibuprofen IB	Ibuprofen	McKesson	ANDA	Current
62011-0213	Health Mart Ibuprofen IB	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
62011-0222	Health Mart Ibuprofen IB	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
62011-0222	Health Mart Ibuprofen IB	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
62011-0222	Health Mart Ibuprofen IB	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
62011-0222	Health Mart Ibuprofen IB	Ibuprofen	McKesson	ANDA	Current
63981-517	kirkland signature ibuprofen ib	Ibuprofen	Costco Wholesale Company	ANDA	Current
63981-517	kirkland signature ibuprofen ib	Ibuprofen	Costco Wholesale Company	ANDA	Current
66715-9812	Motrin IB	Ibuprofen	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9812	Motrin IB	Ibuprofen	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9812	Motrin IB	Ibuprofen	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9812	Motrin IB	Ibuprofen	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9812	Motrin IB	Ibuprofen	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9812	Motrin IB	Ibuprofen	Lil' Drug Store Products, Inc.	ANDA	Current
67414-240	Motrin IB	IBUPROFEN	Jones Contract Packaging Services	ANDA	Current
67414-240	Motrin IB	IBUPROFEN	Jones Packaging Inc	ANDA	Current
67414-240	Motrin IB	IBUPROFEN	Jones Healthcare Group - Packaging Services, Inc	ANDA	Current
68391-517	berkley and jensen ibuprofen	Ibuprofen	BJWC	ANDA	Current
68391-517	berkley and jensen ibuprofen	Ibuprofen	BJWC	ANDA	Current
68391-517	berkley and jensen ibuprofen	Ibuprofen	BJWC	ANDA	Current
69168-390	Ibuprofen 200mg	Ibuprofen 200mg	Allegiant Health	ANDA	Current
69842-183	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-183	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
70000-0003	leader ibuprofen	Ibuprofen	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0003	leader ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
70000-0003	leader ibuprofen	Ibuprofen	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0308	leader ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
70000-0308	leader ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
70000-0308	leader ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
70000-0308	leader ibuprofen	Ibuprofen	Cardinal Health 110, LLC. dba Leader	ANDA	Current
72288-517	basic care ibuprofen	Ibuprofen	Amazon.com Services LLC	ANDA	Current
72288-517	basic care ibuprofen	Ibuprofen	Amazon.com Services LLC	ANDA	Current