Application 074431

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLURBIPROFEN	FLURBIPROFEN	TABLET;ORAL	100MG	No	No

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
A074431-001	FLURBIPROFEN	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31

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	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL	AB		1995-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL	AB		1995-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL	AB		1995-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL	AB		1995-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074431-001	FLURBIPROFEN	100MG	TABLET / ORAL		RS	1995-05-31	`e64feba35796…`

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	A074431-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074431-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074431-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074431-001	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flurbiprofen	FLURBIPROFEN	Genus Lifesciences	4670cf21-eb0e-4f5a-ab22-41af85733525	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074431 application number: ANDA074431
LURBIRO	FLURBIPROFEN	IPG Pharmaceuticals, Inc.	7ebf7427-eaae-4035-a6b2-0ea6381e8763	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074431 application number: ANDA074431
Flurbiprofen	FLURBIPROFEN	NuCare Pharmaceuticals,Inc.	6c6a0daa-de1b-5455-e053-2991aa0a4cf8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074431 application number: ANDA074431 ndc (product): 68071-4436

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0711	Flurbiprofen	Flurbiprofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0711	Flurbiprofen	Flurbiprofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0711	Flurbiprofen	Flurbiprofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0711	Flurbiprofen	Flurbiprofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0711	Flurbiprofen	Flurbiprofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0711	Flurbiprofen	Flurbiprofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
43063-992	Flurbiprofen	Flurbiprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-992	Flurbiprofen	Flurbiprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-992	Flurbiprofen	Flurbiprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-992	Flurbiprofen	Flurbiprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-992	Flurbiprofen	Flurbiprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-992	Flurbiprofen	Flurbiprofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-918	Flurbiprofen	Flurbiprofen	medsource pharmaceuticals	ANDA	Current
45865-918	Flurbiprofen	Flurbiprofen	medsource pharmaceuticals	ANDA	Current
49999-311	Flurbiprofen	Flurbiprofen	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-0509	Flurbiprofen	Flurbiprofen	A-S Medication Solutions	ANDA	Current
63629-8338	Flurbiprofen	Flurbiprofen	Bryant Ranch Prepack	ANDA	Current
63629-8338	Flurbiprofen	Flurbiprofen	Bryant Ranch Prepack	ANDA	Current
63629-8338	Flurbiprofen	Flurbiprofen	Bryant Ranch Prepack	ANDA	Current
63629-8808	Flurbiprofen	Flurbiprofen	Bryant Ranch Prepack	ANDA	Current
63629-8808	Flurbiprofen	Flurbiprofen	Bryant Ranch Prepack	ANDA	Current
63629-8808	Flurbiprofen	Flurbiprofen	Bryant Ranch Prepack	ANDA	Current
68071-2480	Flurbiprofen	Flurbiprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4436	Flurbiprofen	Flurbiprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4436	Flurbiprofen	Flurbiprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7341	Flurbiprofen	Flurbiprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7341	Flurbiprofen	Flurbiprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7341	Flurbiprofen	Flurbiprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7341	Flurbiprofen	Flurbiprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7341	Flurbiprofen	Flurbiprofen	Preferred Pharmaceuticals Inc.	ANDA	Current