Application 209495

Type: ANDA
Sponsor: GLENMARK PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	No	No
002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209495-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2019-05-10
A209495-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2019-05-10

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209495-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209495-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-05-10	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209495-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209495-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209495-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209495-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209495-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209495-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209495-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209495-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209495-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209495-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209495-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209495-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209495-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209495-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209495-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209495-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209495-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209495-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209495-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209495-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209495-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209495-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209495-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209495-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209495-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209495-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209495-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209495-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209495-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209495-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209495-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209495-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209495-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209495-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209495-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209495-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209495-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209495-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209495-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209495-002	AB	1	`1c564ffb4f44…`

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
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Glenmark Pharmaceuticals Inc., USA	a6430045-ae60-4a16-92b9-2975cb497629	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209495 application number: ANDA209495 ndc (product): 68462-391 ndc (product): 68462-390
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	def3f166-e740-41ed-82c0-9b03dd6432b1	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209495 application number: ANDA209495 ndc (product): 50090-6128
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	e79725fe-54c8-4dcb-a03a-0c91cc20cf77	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209495 application number: ANDA209495 ndc (product): 50090-6213

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6128	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
50090-6213	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
68462-390	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-390	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-391	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-391	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-557	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-557	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-558	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-558	Esomeprazole Magnesium	Esomeprazole Magnesium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current