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 18 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	A-S Medication Solutions	47711610-6577-4805-a2ce-cf9b7cbfa812	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AMERIFOODS TRADING COMPANY	3802ebc9-83ca-602a-e063-6294a90a11c8	2025-11-20	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Golden State Medical Supply, Inc.	3ff501eb-5ae3-8824-e063-6394a90ac58e	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f099a-ee59-0b9a-e053-2a95a90a2fe1	2025-11-18	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f40f5-625d-3f2e-e053-2a95a90a438b	2025-11-18	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f42a7-c2d8-4a51-e053-2a95a90a1677	2025-11-18	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f308f-0ca5-12fa-e053-2995a90a47fc	2025-11-18	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
MOTRIN IB	IBUPROFEN	R J General Corporation	afa87bb5-7fcb-4ccd-acac-f7931242181f	2025-11-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200 mg	IBUPROFEN	R J General Corporation	dd9aaf80-6c2b-41a3-87b9-61642aaed4f0	2025-11-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200 mg	IBUPROFEN	R J General Corporation	1c18a2da-1718-4c00-aea8-9fb4a3418312	2025-11-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200 mg	IBUPROFEN	R J General Corporation	cd3060a5-3b90-42e4-89cd-3b620859045f	2025-11-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200 mg	IBUPROFEN	R J General Corporation	1c7221ae-52d1-4d18-b586-c47ff656150d	2025-11-17	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c447fc6b-e9ef-447a-9609-5f893e18dfa7	2025-11-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Family Dollar Services Inc	89ed9311-2185-4660-b219-9ea67b1a71ec	2025-11-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Topco Associates, LLC	bcf7d4c1-1f99-48df-8f74-9abeefa8d41d	2025-11-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	d1f20e10-0128-f2e5-1a03-6da5d7288a4e	2025-11-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	bf7d0929-a7d5-4164-9c24-566eddcd6489	2025-11-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	ce215099-91b0-43fd-8ac9-17fe6508842c	2025-11-11	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	da9d0301-ec14-40c5-b0b9-17096913a849	2025-11-11	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
GOODNOW PAIN RELIEF	IBUPROFEN	Gobrands, Inc	0759085d-6ac3-446b-ac2c-8dc30e32e1d1	2025-11-08	Warnings	Name fallback 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