Application 217738

Type: ANDA
Sponsor: SCIEGEN PHARMS

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 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
A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-10-11
A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217738-001	AB
A217738-002	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.

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	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217738-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217738-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-10-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217738-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217738-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217738-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217738-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217738-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217738-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217738-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217738-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217738-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217738-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217738-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217738-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217738-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217738-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217738-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217738-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217738-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217738-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217738-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217738-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217738-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217738-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217738-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217738-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217738-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217738-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217738-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217738-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217738-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217738-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217738-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217738-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217738-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217738-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217738-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217738-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217738-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217738-002	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217738-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217738-002	AB	1	`a50c72e98297…`

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	Proficient Rx LP	cfd4ef00-cfc4-4794-99fe-faa45eb2f617	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217738 application number: ANDA217738
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	PHOENIX RX LLC	4c25c106-b5ca-079f-e063-6394a90a4978	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217738 application number: ANDA217738
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc	470496f5-a71d-40b2-bf11-3a8d3d790962	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217738 application number: ANDA217738
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ScieGen Pharmaceuticals, Inc	167340c2-1234-4d00-b4e2-cccf3d270fda	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217738 application number: ANDA217738
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	f3a3eea2-f6b3-4559-8536-26c1125df3e1	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217738 application number: ANDA217738