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 14 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	HYVEE INC	459fc670-32a3-61a6-e063-6294a90aea5a	2026-01-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	8ebe3e16-b7ae-d333-6671-5bc935e25900	2026-01-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	HyVee Inc	2fd51545-1d1f-4b2e-a084-d28ba223e720	2026-01-13	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
ibuprofen infants	IBUPROFEN	HyVee Inc	e8fcaf17-234a-4d64-b621-9ca505884b0a	2026-01-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c	2026-01-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	c0c64ba5-b6b0-4221-9e44-110d92c93782	2026-01-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Coupler LLC	4831785a-cde2-79a2-e063-6294a90a9a40	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	c93da67f-f42e-4baa-976b-73c71ba6dd71	2026-01-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
GOOD SENSE CHILDRENS IBUPROFEN	IBUPROFEN	L. Perrigo Company	cd06ffc5-4921-4b2d-88ea-939fa4daf59c	2026-01-09	Warnings	Name fallback generic name: IBUPROFEN
Xpect Ibuprofen	IBUPROFEN	Cintas Corporation	976ba88a-6428-40d1-a2fd-eac64963ba1d	2026-01-08	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Strides Pharma Inc	69b208ff-83f5-40d1-a2ff-d54b390e46e4	2026-01-08	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
ibuprofen	IBUPROFEN	CVS Pharmacy	ace493e6-91bc-41aa-8e5c-5bc14981de91	2026-01-06	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	Safeway, Inc.	22927a12-6837-4d57-8e60-043000f2f208	2026-01-05	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	DOLGENCORP, LLC	37ccb303-c70e-48b3-a8a3-2b0097cf8f88	2026-01-05	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
DG Health Ibuprofen	IBUPROFEN	Dolgencorp Inc	1dd4ffc5-3132-419b-8e70-78a7bb71da62	2026-01-02	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	2f12a20c-4293-d18a-e063-6294a90a3afc	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	c20f1f4d-59b3-6bbe-e053-2a95a90abaf1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	ab313564-27dc-0297-e053-2a95a90a6690	2026-01-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	dac07d8f-6b6f-20ab-e053-2a95a90af3ba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	da6c72ad-009f-3d7f-e053-2995a90a68e9	2026-01-01	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.

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