Application 075416

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG BASE	No	No
002	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 375MG BASE	No	No
003	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 750MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
A075416-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27
A075416-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23
A075416-003	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075416-001	AB
A075416-002	AB
A075416-003	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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075416-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075416-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075416-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075416-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075416-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075416-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075416-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075416-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075416-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075416-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075416-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075416-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075416-001	AB	1	`79d66fd596c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	Teva Pharmaceuticals, Inc.	826fd9e3-22fe-408b-820c-f2b710189555	2024-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075416 application number: ANDA075416 ndc (product): 0480-0952 ndc (product): 0480-0953 ndc (product): 0480-0951

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0480-0951	Naproxen Sodium	naproxen sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-0952	Naproxen sodium	naproxen sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-0953	Naproxen Sodium	naproxen sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
62037-825	Naproxen Sodium	naproxen sodium	Actavis Pharma, Inc.	ANDA	Current
62037-825	Naproxen Sodium	naproxen sodium	Actavis Pharma, Inc.	ANDA	Current
62037-825	Naproxen Sodium	naproxen sodium	Actavis Pharma, Inc.	ANDA	Current
62037-826	Naproxen Sodium	naproxen sodium	Actavis Pharma, Inc.	ANDA	Current
62037-826	Naproxen Sodium	naproxen sodium	Actavis Pharma, Inc.	ANDA	Current
62037-826	Naproxen Sodium	naproxen sodium	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22471	ORIG	2014-08-01