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 39 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	c7e59784-a338-4922-a806-98c7505957cd	2023-11-10	Warnings	Name fallback generic name: IBUPROFEN
Concentrated ibuprofen infants	IBUPROFEN	Chain Drug Marketing Association Inc.	c9ae72d8-d205-4736-9bc4-2325cd77d36b	2023-11-03	Warnings	Name fallback generic name: IBUPROFEN
foster and thrive ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	68d67a25-e669-47c7-8410-9f304b914ff1	2023-10-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Geri-Care Pharmaceutical Corp	0744c3ca-4224-4f6a-a033-880949b544fd	2023-10-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC.	059cb22f-f6db-5d03-e063-6294a90a9ec1	2023-10-27	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	ba0baba6-a7f9-4e4c-88f7-c7fbecc61f25	2023-10-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2b9e71c5-9b32-4b1b-a479-e5457a1f9afd	2023-10-16	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Meijer Distribution Inc	e578de96-747e-4104-8db6-e6521e6052a5	2023-10-09	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	793e4b36-8208-4fa3-9f4f-9e9e72648280	2023-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	8fafa916-733a-4c7d-99da-6ca2ed54e1e4	2023-10-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	fed2f7ae-2825-f967-e053-6294a90adc0a	2023-10-05	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	9f020645-ba77-49e1-b9f1-0e36cdf26adb	2023-10-05	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb613c44-e125-0f40-e053-2995a90a7ca5	2023-10-02	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb60e636-41fe-49fb-e053-2a95a90a0616	2023-09-29	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Signature Care Ibuprofen	IBUPROFEN	Safeway	93edca03-fdf1-453f-8efe-5f0b8eef41e4	2023-09-28	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Better Living Brands LLC	f6ef7f73-b5ab-4c82-e053-6394a90ac81e	2023-09-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN CAPSULES 200 MG	TIME CAP LABORATORIES, INC.	c7c51cf3-9e95-f8d0-e053-2995a90a7371	2023-09-18	Warnings	Name fallback brand name: Ibuprofen
Ibuprofen Minis	IBUPROFEN	Aurohealth LLC	d0b03d99-477f-4250-ac84-576b1baf2eed	2023-09-15	Warnings	Name fallback generic name: IBUPROFEN
Dolex Flex	IBUPROFEN	Pharmadel LLC	822d9def-504c-9beb-e053-2991aa0a280e	2023-09-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	e4644cb5-7fae-456a-98d3-62ba521cd0b2	2023-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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