Application 074211

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN	NAPROXEN	TABLET;ORAL	250MG	No	No
002	NAPROXEN	NAPROXEN	TABLET;ORAL	375MG	No	No
003	NAPROXEN	NAPROXEN	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A074211-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	1994-02-28
A074211-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	1994-02-28
A074211-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	1994-02-28

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074211-002	NAPROXEN	375MG	TABLET / ORAL	1994-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074211-003	NAPROXEN	500MG	TABLET / ORAL	1994-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074211-001	NAPROXEN	250MG	TABLET / ORAL	1994-02-28	`301d65b070ca…`

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 8 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	NCS HealthCare of KY, Inc dba Vangard Labs	62a12771-bde9-4bc3-9ce9-672c8e31f020	2017-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.