Application 078314

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078314-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB		2007-04-27
A078314-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB		2007-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078314-001	AB
A078314-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A078314-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078314-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078314-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078314-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078314-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078314-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078314-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078314-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078314-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078314-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078314-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078314-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078314-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078314-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078314-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078314-002	AB	1	`bb7c543d1eb4…`

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
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	36996557-3227-b753-e063-6394a90a7b6f	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078314 application number: ANDA078314
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	83dd8829-7ba0-4a8d-a979-41a5e077c49f	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078314 application number: ANDA078314
Naproxen Sodium	NAPROXEN SODIUM	Glenmark Pharmaceuticals Inc., USA	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078314 application number: ANDA078314 ndc (product): 68462-179 ndc (product): 68462-178

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-063	Naproxen Sodium	Naproxen Sodium	Blenheim Pharmacal, Inc.	ANDA	Current
10544-275	Naproxen Sodium	Naproxen Sodium	Blenheim Pharmacal, Inc.	ANDA	Current
10544-276	Naproxen Sodium	Naproxen Sodium	Blenheim Pharmacal, Inc.	ANDA	Current
45865-519	Naproxen Sodium	Naproxen Sodium	Medsource Pharmaceuticals	ANDA	Current
45865-519	Naproxen Sodium	Naproxen Sodium	Medsource Pharmaceuticals	ANDA	Current
55289-467	Naproxen Sodium	Naproxen Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
61919-183	ANAPROX	NAPROXEN SODIUM	DIRECT RX	ANDA	Current
61919-183	ANAPROX	NAPROXEN SODIUM	DIRECT RX	ANDA	Current
63629-3638	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
63629-3638	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
63874-339	Naproxen Sodium	Naproxen Sodium	Altura Pharmaceuticals, Inc.	ANDA	Current
63874-489	Naproxen Sodium	Naproxen Sodium	Altura Pharmaceuticals, Inc.	ANDA	Current
68071-3054	Naproxen Sodium	Naproxen Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68462-178	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-178	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-178	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-178	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-178	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-179	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-179	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-179	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-179	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-179	Naproxen Sodium	Naproxen Sodium	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68788-6934	Naproxen Sodium	Naproxen Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6934	Naproxen Sodium	Naproxen Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6934	Naproxen Sodium	Naproxen Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0409	Naproxen Sodium	Naproxen Sodium	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23901	ORIG	2007-05-08