Application 074978

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074978-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074978-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074978-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074978-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074978-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074978-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074978-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074978-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074978-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074978-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074978-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074978-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074978-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074978-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074978-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074978-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074978-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074978-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074978-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074978-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074978-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074978-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074978-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074978-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074978-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074978-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074978-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074978-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074978-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074978-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074978-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074978-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074978-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074978-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074978-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074978-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074978-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074978-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074978-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074978-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074978-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074978-001	AB	1	`e64feba35796…`

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Actavis Pharma, Inc.	3d156d13-25d8-4cfc-8285-5f7ebf48cf45	2024-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074978 application number: ANDA074978 ndc (product): 0472-2002
Ibuprofen	IBUPROFEN	Proficient Rx LP	72b32512-05c7-4113-b0cc-de9c97de2abb	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074978 application number: ANDA074978 ndc (product): 71205-367

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0472-1270	Ibuprofen	Ibuprofen	Actavis Pharma, Inc.	ANDA	Current
0472-2002	Ibuprofen	Ibuprofen	Actavis Pharma, Inc.	ANDA	Current
0472-2002	Ibuprofen	Ibuprofen	Actavis Pharma, Inc.	ANDA	Current
0472-2002	Ibuprofen	Ibuprofen	Actavis Pharma, Inc.	ANDA	Current
0472-2002	Ibuprofen	Ibuprofen	Actavis Pharma, Inc.	ANDA	Current
0472-2002	Ibuprofen	Ibuprofen	Actavis Pharma, Inc.	ANDA	Current
0472-2002	Ibuprofen	Ibuprofen	Actavis Pharma, Inc.	ANDA	Current
55154-4060	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-4065	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-4065	Ibuprofen	Ibuprofen	Cardinal Health 107, LLC	ANDA	Current
66689-009	Ibuprofen	Ibuprofen	VistaPharm, Inc.	ANDA	Current
66689-009	Ibuprofen	Ibuprofen	VistaPharm, Inc.	ANDA	Current
66689-339	Ibuprofen	Ibuprofen	VistaPharm, Inc.	ANDA	Current
66689-339	Ibuprofen	Ibuprofen	VistaPharm, Inc.	ANDA	Current
66689-339	Ibuprofen	Ibuprofen	VistaPharm, Inc.	ANDA	Current
66689-339	Ibuprofen	Ibuprofen	VistaPharm, Inc.	ANDA	Current
71205-367	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39450	ORIG	2014-12-19
8480	SUPPL	2014-11-13
22397	ORIG	1998-03-25