Application 071644

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071644-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL			1988-02-01

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 2 · 43 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	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071644-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1988-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071644-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1988-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071644-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1988-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071644-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1988-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071644-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1988-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071644-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1988-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071644-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1988-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071644-001	IBUPROFEN	400MG	TABLET / ORAL		1988-02-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A071644-001	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A071644-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071644-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071644-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071644-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071644-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071644-001	AB	1	`ea99ee380514…`

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 21 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	2910b50b-c8de-382b-e054-00144ff88e88	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Green Guard Ibuprofen Relief	IBUPROFEN	Unifirst First Aid	0798e401-8247-2fce-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique at Home Iprin	IBUPROFEN	Unifirst First Aid Corporation	b5547f33-2a81-867d-e053-2995a90aa2d0	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	0607edb0-1b3a-2ccd-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	28d45743-d298-29db-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Unishield Ibuprofen	IBUPROFEN	Unishield	b9e2e2ba-e2ad-eace-e053-2995a90aed35	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	07afce34-aaea-50a1-e054-00144ff88e88	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Uline Ibuprofen	IBUPROFEN	Uline	d7342a15-9d49-74ed-e053-2a95a90a22cc	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
McKesson Ibuprofen 200 mg	IBUPROFEN	McKesson Medical-Surgical	ca75b9fe-5bc8-ab90-e053-2995a90a52fb	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Henry Schein Ibuprofen	IBUPROFEN	Henry Schein Inc.	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	2025-09-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Thompson	IBUPROFEN	Thompson Safety	ccfbc048-f666-3188-e053-2995a90ae08f	2025-09-08	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Walgreen Company	37c9b887-190a-4daf-8199-f406913132f0	2025-09-03	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sam's West Inc	6293a134-860d-4d12-9e4b-28490f824108	2025-09-03	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Better Living Brands, LLC	fab39a0a-882b-bf96-e053-6294a90a2932	2025-09-02	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	WALGREEN CO.	fea3c4b2-cf96-2425-e053-6394a90ac697	2025-09-02	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	af0ec23c-cefc-40a9-ab9a-03b8528d4e13	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	0e1bcb06-be48-4efc-82e2-516582e02348	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	KROGER COMPANY	15e72384-3a04-242d-e063-6294a90aa0fa	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	cf7b38fc-0590-126a-e053-2a95a90a3e78	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Chalkboard Health	c63eb5c6-adac-4d23-9661-1081ba4591ba	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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