Application 213699

Type: ANDA
Sponsor: AJANTA PHARMA 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 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
A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2022-10-06
A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2022-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213699-001	AB
A213699-002	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 · 52 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	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	A213699-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213699-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213699-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213699-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213699-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213699-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213699-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213699-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213699-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213699-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213699-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213699-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-002	AB	1	`a67488948f0b…`

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 · 7 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	Preferred Pharmaceuticals Inc.	65b892f2-8385-4bb0-8121-a58b01e8d13d	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	5fd008ef-8388-48e9-8d38-76e0106bd5b6	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	b295a90e-320f-4414-b80a-d11f06c00c96	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Ajanta Pharma USA Inc.	7ca657dc-4376-4693-8568-99351fac8186	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699 ndc (product): 27241-202 ndc (product): 27241-203
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	PHOENIX RX LLC	3a652450-525b-4839-e063-6294a90ac287	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	PHOENIX RX LLC	3a6637ca-0c55-f648-e063-6294a90aaef7	2025-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	19aadd4b-647b-4c75-9059-9a2c68a18561	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-202	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Ajanta Pharma USA Inc.	ANDA	Current
27241-203	Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	Ajanta Pharma USA Inc.	ANDA	Current