Application 076460

Type: ANDA
Sponsor: AVEMA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	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
A076460-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2003-11-26

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	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	c6dcc329-bab5-41ab-94e7-625e07628fd6	2025-01-28	Warnings	Exact identifier application applno (ANDA): 076460 application number: ANDA076460 ndc (product): 63548-0185
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	1662a495-4f6a-4515-a405-557681e1a496	2023-02-09	Warnings	Exact identifier application applno (ANDA): 076460 application number: ANDA076460 ndc (product): 63548-0234

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30142-186	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
30142-235	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
33992-0209	Ibuprofen	Ibuprofen	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0209	Ibuprofen	Ibuprofen	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
49035-186	Ibuprofen	Ibuprofen	EQUATE (Walmart Stores, Inc.)	ANDA	Current
49035-186	Ibuprofen	Ibuprofen	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-186	Ibuprofen	Ibuprofen	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
53329-677	Ibuprofen	Ibuprofen	Medline industries, Inc.	ANDA	Current
55316-235	Ibuprofen	Ibuprofen	Healthy Accents (DZA Brands, LLC)	ANDA	Current
55316-235	Ibuprofen	Ibuprofen	Healthy Accents (DZA Brands, LLC)	ANDA	Current
55319-035	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-035	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-186	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-186	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-186	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-249	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-249	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55910-023	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-023	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-023	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
59726-186	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-235	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-235	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
63548-0185	Ibuprofen	Ibuprofen	Avema Pharma Solutions	ANDA	Current
63548-0185	Ibuprofen	Ibuprofen	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0186	Ibuprofen	Ibuprofen	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0186	Ibuprofen	Ibuprofen	Avema Pharma Solutions	ANDA	Current
63548-0234	Ibuprofen	Ibuprofen	Avema Pharma Solutions	ANDA	Current
63548-0234	Ibuprofen	Ibuprofen	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0235	Ibuprofen	Ibuprofen	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0235	Ibuprofen	Ibuprofen	Avema Pharma Solutions	ANDA	Current
66715-5807	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6820	Lil Drug Store Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6939	Ibuprofen	Ibuprofen	Lil' Drug Store Products, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22563	ORIG	2012-03-28