Application 078486

Type: ANDA
Sponsor: DR REDDYS LABS 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 1.

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
A078486-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-26
A078486-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB		2007-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078486-001	AB
A078486-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078486-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078486-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078486-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078486-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078486-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078486-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078486-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078486-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078486-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078486-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078486-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078486-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078486-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078486-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078486-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078486-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078486-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078486-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen sodium	NAPROXEN SODIUM	PHOENIX RX LLC	47d18804-d8d6-8248-e063-6394a90a48a9	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486
Naproxen sodium	NAPROXEN SODIUM	A-S Medication Solutions	8181bb7a-d917-4388-bcb0-a74671b07b06	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486 ndc (product): 50090-5238
Naproxen sodium	NAPROXEN SODIUM	Dr. Reddy's Laboratories Inc.	37de42a6-701b-7f6e-e631-519e2ea78b54	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486 ndc (product): 43598-495 ndc (product): 43598-494
Naproxen sodium	NAPROXEN SODIUM	Quality Care Products, LLC	e2ed5556-8109-4002-bf8b-827518a84ea4	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486 ndc (product): 55700-625
Naproxen sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	42f6a3a0-5a1e-40ca-8949-b8870dd95d2e	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486 ndc (product): 71335-1650

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-494	Naproxen sodium	Naproxen sodium	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-494	Naproxen sodium	Naproxen sodium	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-494	Naproxen sodium	Naproxen sodium	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-495	Naproxen sodium	Naproxen sodium	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-495	Naproxen sodium	Naproxen sodium	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-495	Naproxen sodium	Naproxen sodium	Dr. Reddy's Laboratories Inc.	ANDA	Current
50090-5238	Naproxen sodium	Naproxen sodium	A-S Medication Solutions	ANDA	Current
55700-625	Naproxen sodium	Naproxen sodium	Quality Care Products, LLC	ANDA	Current
55700-625	Naproxen sodium	Naproxen sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-625	Naproxen sodium	Naproxen sodium	Quality Care Products, LLC	ANDA	Current
55700-625	Naproxen sodium	Naproxen sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-625	Naproxen sodium	Naproxen sodium	Quality Care Products, LLC	ANDA	Current
55700-625	Naproxen sodium	Naproxen sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
70518-0178	Naproxen sodium	Naproxen sodium	REMEDYREPACK INC.	ANDA	Current
71335-1650	Naproxen sodium	Naproxen sodium	Bryant Ranch Prepack	ANDA	Current
71335-1650	Naproxen sodium	Naproxen sodium	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23910	ORIG	2007-08-16