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 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078558-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078558-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078558-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078558-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078558-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078558-003	AB	1	`caaa826d4ba7…`
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…`

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 · 12 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 ndc (product): 65162-466 ndc (product): 65162-465 ndc (product): 65162-464
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	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 ndc (product): 80425-0047
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
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
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
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

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 3 of 3 · 239 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63739-691	Ibuprofen	Ibuprofen	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-691	Ibuprofen	Ibuprofen	McKesson Corporation dba SKY Packaging	ANDA	Current
63874-322	Ibuprofen	Ibuprofen	Altura Pharmaceuticals, Inc.	ANDA	Current
63874-323	Ibuprofen	Ibuprofen	Altura Pharmaceuticals, Inc.	ANDA	Current
63874-324	Ibuprofen	Ibuprofen	Altura Pharmaceuticals, Inc.	ANDA	Current
64725-0465	Ibuprofen	Ibuprofen	TYA Pharmaceuticals	ANDA	Current
65162-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-464	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-465	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-466	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals LLC	ANDA	Current
66116-366	Ibuprofen	Ibuprofen	MedVantx, Inc.	ANDA	Current
66116-367	Ibuprofen	Ibuprofen	MedVantx, Inc.	ANDA	Current
66116-368	Ibuprofen	Ibuprofen	MedVantx, Inc.	ANDA	Current
66267-118	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-118	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66336-030	Ibuprofen	Ibuprofen	Dispensing Solutions, Inc.	ANDA	Current
66336-430	Ibuprofen	Ibuprofen	Dispensing Solutions, Inc.	ANDA	Current
66336-556	Ibuprofen	Ibuprofen	Dispensing Solutions, Inc.	ANDA	Current
67046-307	Ibuprofen	Ibuprofen	Contract Pharmacy Services-PA	ANDA	Current
67046-313	Ibuprofen	Ibuprofen	Contract Pharmacy Services-PA	ANDA	Current
67296-0538	Ibuprofen	Ibuprofen	RedPharm Drug Inc.	ANDA	Current
67296-0574	Ibuprofen	Ibuprofen	RedPharm Drug Inc.	ANDA	Current
67296-0618	Ibuprofen	Ibuprofen	RedPharm Drug Inc.	ANDA	Current
67296-1799	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1799	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1800	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
68071-2319	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2319	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2627	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2815	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-658	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-658	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-658	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-658	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-703	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-703	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-703	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-703	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-772	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-772	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-772	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68084-772	Ibuprofen	Ibuprofen	American Health Packaging	ANDA	Current
68387-208	Ibuprofen	Ibuprofen	Keltman Pharmaceuticals Inc.	ANDA	Current
68387-210	Ibuprofen	Ibuprofen	Keltman Pharmaceuticals Inc.	ANDA	Current
68788-9113	Ibuprofen	Ibuprofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9114	Ibuprofen	Ibuprofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9115	Ibuprofen	Ibuprofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0407	Ibuprofen	Ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-0535	Ibuprofen	Ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-0535	Ibuprofen	Ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-1839	Ibuprofen	Ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-1839	Ibuprofen	Ibuprofen	REMEDYREPACK INC.	ANDA	Current
71335-0458	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71335-0458	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71335-0458	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71335-0591	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71335-0591	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71610-154	Ibuprofen	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-176	Ibuprofen	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-296	Ibuprofen	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
75921-466	Ibuprofen	Ibuprofen	Life Line Home Care Services, Inc.	ANDA	Current
80425-0047	Motrin	Ibuprofen 800mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0047	Motrin	Ibuprofen 800mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0047	Motrin	Ibuprofen 800mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0047	Motrin	Ibuprofen 800mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0047	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0047	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0047	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current