Application 090796

Type: ANDA
Sponsor: MARKSANS PHARMA

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 44.

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
A090796-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21
A090796-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21
A090796-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090796-001	AB
A090796-002	AB
A090796-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090796-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090796-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090796-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090796-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090796-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090796-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090796-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090796-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-001	AB	1	`79d66fd596c7…`

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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	54b25106-5580-119d-e054-00144ff88e88	2024-07-17		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	999aa615-72b2-9296-e053-2a95a90ac70b	2024-06-20		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	9973bfa2-693a-1165-e053-2995a90a4b1d	2024-06-20		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	99d7cf65-3ec2-24eb-e053-2a95a90acc5e	2024-06-20		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	6d86ce94-a06a-2769-e053-2991aa0afb95	2024-06-10		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	6365b2d6-2337-70c0-e053-2a91aa0aa960	2024-06-06		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
ibuprofen	IBUPROFEN	SKYA HEALTH, LLC	1c28af16-7246-4e4c-a1be-939655c37242	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	77adb094-869c-44b4-8a4e-b739ac9cd701	2021-04-20		Exact identifier application applno (ANDA): 090796 application number: ANDA090796 ndc (product): 71610-532
ibuprofen	IBUPROFEN	Proficient Rx LP	924d2dd0-3b7d-42ec-b617-86729dba2b95	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	Bryant Ranch Prepack	6d189e86-4c36-43f5-b406-a342458d4155	2020-05-27		Exact identifier application applno (ANDA): 090796 application number: ANDA090796 ndc (product): 71335-1396 ndc (product): 71335-1503 ndc (product): 71335-1517

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 · 210 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0005	IBUPROFEN	IBUPROFEN	REMEDYREPACK INC.	ANDA	Current
70518-0098	ibuprofen	ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-2432	IBUPROFEN	IBUPROFEN	REMEDYREPACK INC.	ANDA	Current
70518-2432	IBUPROFEN	IBUPROFEN	REMEDYREPACK INC.	ANDA	Current
70518-3313	IBUPROFEN	IBUPROFEN	REMEDYREPACK INC.	ANDA	Current
70934-051	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-051	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-051	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-051	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-051	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-051	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-051	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-375	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-375	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-375	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-375	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-375	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-509	IBUPROFEN	IBUPROFEN	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1396	IBUPROFEN	IBUPROFEN	Bryant Ranch Prepack	ANDA	Current
71335-1396	IBUPROFEN	IBUPROFEN	Bryant Ranch Prepack	ANDA	Current
71335-1503	IBUPROFEN	IBUPROFEN	Bryant Ranch Prepack	ANDA	Current
71335-1517	IBUPROFEN	IBUPROFEN	Bryant Ranch Prepack	ANDA	Current
71610-387	IBUPROFEN	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-532	IBUPROFEN	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-231	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-266	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-266	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-266	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-266	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-266	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-266	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
72189-324	IBUPROFEN	IBUPROFEN	Direct Rx	ANDA	Current
72189-324	IBUPROFEN	IBUPROFEN	Direct Rx	ANDA	Current
72189-324	IBUPROFEN	IBUPROFEN	Direct Rx	ANDA	Current
80425-0089	Motrin	Ibuprofen 800mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0089	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0089	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0089	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0132	Ibuprofen	Ibuprofen 600mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0132	Ibuprofen	Ibuprofen 600mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0132	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0132	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0243	Ibuprofen	Ibuprofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current