Application 204206

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE;375MG	No	No
002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE;500MG	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
A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18
A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204206-001	AB
A204206-002	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 2 · 76 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	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2020-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204206-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204206-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A204206-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204206-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204206-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204206-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204206-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204206-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204206-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204206-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204206-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204206-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204206-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204206-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204206-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204206-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204206-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204206-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204206-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204206-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204206-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204206-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204206-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204206-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204206-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204206-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204206-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204206-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204206-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204206-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204206-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204206-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204206-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204206-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204206-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204206-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204206-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204206-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204206-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204206-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204206-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204206-002	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 and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Doc Rx	733a93ff-8240-4afa-ba28-b0a6f8514efe	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204206 application number: ANDA204206
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	6368a3be-4b79-466b-8ec4-11fc3ac623cc	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204206 application number: ANDA204206
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	3f1c66f0-2d9d-4be1-8656-1dbed2c9c715	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204206 application number: ANDA204206
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Asclemed USA, Inc.	7b3af5a8-0c92-43f4-af13-7a47dca20e92	2024-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204206 application number: ANDA204206
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Limited	1ef3fe94-9bbb-934d-a09b-d19a1d23a4d5	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204206 application number: ANDA204206 ndc (product): 55111-289 ndc (product): 55111-701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-289	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-289	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-289	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-289	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-701	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-701	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-701	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-701	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62235	ORIG	2020-03-23