Application 205647

Type: ANDA
Sponsor: HI TECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	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
A205647-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2016-11-03

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	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205647-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205647-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205647-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205647-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205647-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205647-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205647-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205647-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205647-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205647-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205647-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205647-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205647-001	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A205647-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205647-001	AB	1	`cb3db0bc1861…`

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 40 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Best Choice (Valu Merchandisers Company)	04b4ed2b-5f43-4151-b355-ca1bb469658d	2023-08-31	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	fa99f5ec-0306-473b-827f-86cd0a7978ec	2023-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	Care One (Retail Business Services, LLC.)	b5e9bd39-d2c5-4a6c-b0da-8e41d633b31c	2023-08-24	Warnings	Name fallback generic name: IBUPROFEN
Good Neighbor Pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	74b227c9-8341-44df-a763-cfeb371c0d28	2023-08-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	Strategic Sourcing Services LLC	c363c80f-364a-4047-a246-a1fdeb98a4f0	2023-08-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	BETTER LIVING BRANDS, LLC	eb60a1e5-fb6e-360f-e053-2a95a90ade04	2023-08-03	Warnings	Name fallback brand name: Ibuprofen
betr remedies ibuprofen	IBUPROFEN	Live Betr LLC	0a50820f-1dfa-45b5-824f-2c28822fc6c6	2023-07-26	Warnings	Name fallback generic name: IBUPROFEN
Good Sense Ibuprofen	IBUPROFEN	L. Perrigo Company	f9af5970-18ca-46d5-8d6c-c0fec22a66d5	2023-07-21	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	9164f7e8-81a0-4b71-a2b3-111b2a7541bb	2023-07-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	eaa0a286-a0f0-4979-8af3-c5f4194283fd	2023-06-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Rexall Ibuprofen	IBUPROFEN	Dolgencorp, LLC	d2dc2f71-c0cb-4e6d-85b9-fcf386e207a0	2023-06-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	e4bb22bb-6df6-4016-a023-0b454df9fb0b	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	3329f487-675d-440c-b7c5-d17a2b024275	2023-05-31	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	BluePoint Laboratories	d71acfe2-4643-f50b-e053-2a95a90add8b	2023-05-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7d544d8e-fa76-461f-9417-5f1873912eac	2023-05-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Equate Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	153bc4ac-427d-426a-9bb8-665487e4b169	2023-04-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	1889faea-24a3-45ea-92de-8dc76b9ed5b4	2023-04-25	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	RITE AID CORPORATION	de158883-1175-18fc-e053-2995a90a3c96	2023-04-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	403ec259-3be1-4e0b-ab7b-fee213b7eabe	2023-04-03	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Proficient Rx LP	4ee828df-873d-4379-9a17-a805d97dfe04	2023-04-01	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-584	Ibuprofen	Ibuprofen	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-584	Ibuprofen	Ibuprofen	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-584	Ibuprofen	Ibuprofen	Akorn	ANDA	Current
50383-584	Ibuprofen	Ibuprofen	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
55154-9628	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current