Application 078558

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No
002	IBUPROFEN	IBUPROFEN	TABLET;ORAL	600MG	No	No
003	IBUPROFEN	IBUPROFEN	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078558-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18
A078558-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18
A078558-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078558-001	AB
A078558-002	AB
A078558-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078558-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078558-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078558-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078558-001	AB	1	`8072bd15b7f6…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals LLC	17577b3b-e755-45d1-8b53-775d058578b2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	0387bfaa-daca-48ec-b718-0216a848c16a	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	PHOENIX RX LLC	40202c76-4275-88fd-e063-6394a90a07b2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	American Health Packaging	e080f7da-a506-4c04-a227-c1be77234f01	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 60687-457 ndc (product): 60687-446 ndc (product): 60687-468
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	334e40f3-6da4-ecbe-e063-6294a90a35bf	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fc871659-ce41-1be6-e053-6294a90aa5e4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	af9af7f4-6314-6217-e053-2995a90a5a0f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	faebc392-0fd9-4c71-8471-beba10dda022	2024-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 53746-465 ndc (product): 53746-464 ndc (product): 53746-466
Ibuprofen	IBUPROFEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1a02fa34-b5ae-7183-e063-6294a90a3ae4	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	e90c573d-eb0f-45a5-94d1-efdd3d2b7a11	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 63629-1470
Ibuprofen	IBUPROFEN	A-S Medication Solutions	fa99f5ec-0306-473b-827f-86cd0a7978ec	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Proficient Rx LP	e4bb22bb-6df6-4016-a023-0b454df9fb0b	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 63187-962
Ibuprofen	IBUPROFEN	Proficient Rx LP	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 63187-022 ndc (product): 63187-527 ndc (product): 63187-489

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 239 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51655-049	Ibuprofen	Ibuprofen	Northwind Pharmaceuticals	ANDA	Current
51655-051	Ibuprofen	Ibuprofen	Northwind Pharmaceuticals	ANDA	Current
52959-075	Ibuprofen	Ibuprofen	H.J. Harkins Company, Inc.	ANDA	Current
52959-076	Ibuprofen	Ibuprofen	H.J. Harkins Company, Inc.	ANDA	Current
52959-077	Ibuprofen	Ibuprofen	H.J. Harkins Company, Inc.	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
53808-0271	Ibuprofen	Ibuprofen	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0435	Ibuprofen	Ibuprofen	State of Florida DOH Central Pharmacy	ANDA	Current
55045-1173	Ibuprofen	Ibuprofen	Dispensing Solutions, Inc.	ANDA	Current
55154-4995	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-4995	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-6835	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-6835	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55289-140	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-140	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-140	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-140	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-142	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-142	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-142	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-142	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-590	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-590	Ibuprofen	Ibuprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-446	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-446	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-446	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-446	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-457	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-457	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-457	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-457	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-468	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-468	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-468	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
60687-468	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
61919-124	IBUPROFEN	IBUPROFEN	Direct Rx	ANDA	Current
61919-125	IBUPROFEN	IBUPROFEN	Direct Rx	ANDA	Current
61919-126	IBUPROFEN	IBUPROFEN	Direct Rx	ANDA	Current
63187-022	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63187-022	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63187-489	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63187-489	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63187-527	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63187-527	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63187-962	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63187-962	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
63629-1469	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
63629-1470	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
63629-1470	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
63629-1470	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
63739-672	Ibuprofen	Ibuprofen	McKesson Corporation	ANDA	Current
63739-672	Ibuprofen	Ibuprofen	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-672	Ibuprofen	Ibuprofen	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-684	Ibuprofen	Ibuprofen	McKesson Corporation	ANDA	Current
63739-684	Ibuprofen	Ibuprofen	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-684	Ibuprofen	Ibuprofen	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-691	Ibuprofen	Ibuprofen	McKesson Corporation	ANDA	Current