Application 078132

Type: ANDA
Sponsor: NORTHSTAR HLTHCARE

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	Approval date
A078132-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10
A078132-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10
A078132-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078132-002	IBUPROFEN	600MG	TABLET / ORAL	2007-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078132-003	IBUPROFEN	800MG	TABLET / ORAL	2007-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078132-001	IBUPROFEN	400MG	TABLET / ORAL	2007-09-10	`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 30 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen minis	IBUPROFEN	WR Group, Inc.	e9dad35a-6789-42d6-97da-521db7b16496	2025-03-24	Warnings	Name fallback generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	25bc5cc2-9b6a-47e4-8b3d-2bb370907b61	2025-03-20	Warnings	Name fallback generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	cd15159a-9ed5-453a-9ad4-0c9688204c82	2025-03-19	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Care One (Retail Business Services, LLC.)	a6ce7484-7a32-4985-80bc-883c31be3525	2025-03-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
LEADER CHILDRENS IBUPROFEN	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	913a4bd0-0784-45b4-b05e-3e7c016bbb86	2025-03-03	Warnings	Name fallback generic name: IBUPROFEN
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	2daee8c1-d05e-406b-af65-b81bbbaa244d	2025-03-03	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	02889717-204c-463b-8506-4c5cf18c77d3	2025-03-03	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Discount Drug Mart, Inc	2d58d1c4-b864-6bb8-e063-6394a90a7117	2025-02-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurobindo Pharma Limited	00872852-680a-41b3-901b-b991b12a176d	2025-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Dye Free Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	eccee4c6-aa94-468a-aebd-265d7a9efb6d	2025-02-12	Warnings	Name fallback generic name: IBUPROFEN
Equate Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	01e9b5b9-cb49-4bfa-9a90-ece8940bf768	2025-02-11	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Brisk Pharmaceuticals	2dcbe4bb-fb24-e827-e063-6394a90acf9f	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen infants Drops	IBUPROFEN	Harris Teeter, LLC	2c39a24f-4e42-d75f-e063-6394a90a60fa	2025-02-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fae53f7b-3948-2566-e053-6394a90aae36	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Harris Teeter, LLC	2bb186c8-f791-5f1f-e063-6294a90a87ff	2025-02-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	0bee69ff-cf76-175e-e063-6294a90a42f6	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	2457c045-0b7c-48f4-9422-11623f13d8f1	2025-01-29	Warnings	Name fallback generic name: IBUPROFEN
Advil	IBUPROFEN	Lil' Drug Store Products, Inc.	772360bd-8631-4d24-b4db-5a7e6e1d9a13	2025-01-27	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	efb728f2-fe74-4833-8f0c-710d833abf6e	2025-01-27	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.