Application 091625

Type: ANDA
Sponsor: GRANULES INDIA LTD

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
A091625-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15
A091625-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15
A091625-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091625-001	AB
A091625-002	AB
A091625-003	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	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`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	A091625-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091625-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091625-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091625-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091625-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-001	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 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Proficient Rx LP	444b2ea0-ec42-4bcf-b8d2-38b4b297ada0	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4a86a190-da5d-4b7a-a05f-e3e7ccbfa603	2019-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625

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 4 · 293 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42708-006	Ibuprofen	Ibuprofen	QPharma Inc	ANDA	Current
42708-006	Ibuprofen	Ibuprofen	QPharma Inc	ANDA	Current
42708-006	Ibuprofen	Ibuprofen	QPharma Inc	ANDA	Current
42708-121	Ibuprofen	Ibuprofen	QPharma Inc	ANDA	Current
42708-121	Ibuprofen	Ibuprofen	QPharma Inc	ANDA	Current
42708-121	Ibuprofen	Ibuprofen	QPharma Inc	ANDA	Current
50090-2548	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2548	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2548	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2548	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2548	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2549	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2549	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2549	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2549	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2597	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2597	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2597	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2625	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2625	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2625	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2626	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2626	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2626	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2629	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2629	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2670	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2996	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-3007	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-3007	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-3007	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50436-0319	Ibuprofen	Ibuprofen	Unit Dose Services	ANDA	Current
50436-0319	Ibuprofen	Ibuprofen	Unit Dose Services	ANDA	Current
50436-0321	Ibuprofen	Ibuprofen	Unit Dose Services	ANDA	Current
50436-0321	Ibuprofen	Ibuprofen	Unit Dose Services	ANDA	Current
50436-3200	Ibuprofen	Ibuprofen	Unit Dose Services	ANDA	Current
50436-3200	Ibuprofen	Ibuprofen	Unit Dose Services	ANDA	Current
51655-048	Ibuprofen	Ibuprofen	Northwind Pharmaceuticals	ANDA	Current
51655-048	Ibuprofen	Ibuprofen	Northwind Pharmaceuticals	ANDA	Current
51655-385	Ibuprofen	Ibuprofen	Northwind Pharmaceuticals	ANDA	Current
51655-385	Ibuprofen	Ibuprofen	Northwind Pharmaceuticals	ANDA	Current
53217-364	Ibuprofen	Ibuprofen	Aidarex Pharmaceuticals LLC	ANDA	Current
54348-825	Ibuprofen	IBUPROFEN	PharmPak, Inc.	ANDA	Current
54348-825	Ibuprofen	IBUPROFEN	PharmPak, Inc.	ANDA	Current
54348-830	Ibuprofen	IBUPROFEN	PharmPak, Inc.	ANDA	Current
54348-830	Ibuprofen	IBUPROFEN	PharmPak, Inc.	ANDA	Current
54348-835	Ibuprofen	IBUPROFEN	PharmPak, Inc.	ANDA	Current
54348-835	Ibuprofen	IBUPROFEN	PharmPak, Inc.	ANDA	Current
55700-445	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-445	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-445	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-445	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-445	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-445	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-446	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-446	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-446	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-446	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-446	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-446	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-694	Ibuprofen	Ibuprofen	Quality Care Products, LLC	ANDA	Current
55700-694	Ibuprofen	Ibuprofen	Quality Care Products, LLC	ANDA	Current
55700-694	Ibuprofen	Ibuprofen	Quality Care Products, LLC	ANDA	Current
55700-694	Ibuprofen	Ibuprofen	Quality Care Products, LLC	ANDA	Current
59088-756	IBUPAK	Ibuprofen	PureTek Corporation	ANDA	Current
60760-374	Ibuprofen	Ibuprofen	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-375	Ibuprofen	Ibuprofen	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-463	IBUPROFEN	IBUOROFEN	DIRECT RX	ANDA	Current
61919-463	IBUPROFEN	IBUOROFEN	DIRECT RX	ANDA	Current
61919-463	IBUPROFEN	IBUOROFEN	Direct_Rx	ANDA	Current
61919-463	IBUPROFEN	IBUOROFEN	Direct_Rx	ANDA	Current
61919-463	IBUPROFEN	IBUOROFEN	Direct_Rx	ANDA	Current
61919-628	IBUPROFEN	IBUPROFEN	DIRECT RX	ANDA	Current
61919-628	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-628	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-628	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-683	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-683	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-683	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
62207-354	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current