Application 202413

Type: ANDA
Sponsor: SHANDONG XINHUA

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
004	IBUPROFEN	IBUPROFEN	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202413-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23
A202413-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23
A202413-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23
A202413-004	IBUPROFEN	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202413-001	AB
A202413-002	AB
A202413-003	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 · 143 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	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`5bbf6a4d5a75…`

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	A202413-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202413-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202413-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-001	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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	A-S Medication Solutions	0ce79e85-0b8b-436e-b895-ea5c02eaf4ba	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8d41cc03-dec6-4949-b7c1-7deb2897e2c4	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Proficient Rx LP	43ac478c-43db-4136-8fee-4a43b09681e5	2024-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	ca81671d-1ea8-4c67-802f-adb3a2f087cc	2024-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	214e3b3e-87b9-9ff5-e063-6394a90ae96a	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413

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 1 of 1 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
50090-4228	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-4230	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
51293-843	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-843	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-844	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-844	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-845	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-845	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
55700-633	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-633	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-634	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-634	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58657-680	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-680	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-681	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-681	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-682	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-682	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
62135-400	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-400	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-401	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-401	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-402	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-402	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
67296-1573	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1573	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1633	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1633	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1634	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1634	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
68788-8182	ibuprofen	ibuprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8183	ibuprofen	ibuprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2902	ibuprofen	ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-2902	ibuprofen	ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-3016	ibuprofen	ibuprofen	REMEDYREPACK INC.	ANDA	Current
71335-1177	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71610-456	ibuprofen	ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71862-003	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current
71862-003	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current
71862-007	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current
71862-007	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current