Application 213486

Type: ANDA
Sponsor: GRAVITI 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 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
A213486-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2021-03-19
A213486-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2021-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213486-001	AB
A213486-002	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 · 68 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	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A213486-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213486-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213486-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213486-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213486-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213486-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213486-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213486-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213486-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213486-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213486-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213486-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213486-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213486-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213486-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213486-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213486-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213486-002	AB	1	`87673890dc5c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	REMEDYREPACK INC.	e6e1906f-60be-402f-97f4-6d7bea1a6c08	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	2d21ed0b-a089-46f4-9ebb-f24f9f3af61d	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Quallent Pharmaceuticals Health LLC	7362f930-0879-451e-8de9-8bb8565bfb7e	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486 ndc (product): 82009-033 ndc (product): 82009-034
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Biocon Pharma Inc.,	66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486 ndc (product): 70377-056 ndc (product): 70377-055
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	fe7d7aa8-4f46-83ae-e053-6394a90a01d6	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	f99f95a2-60e4-4781-80a9-e5b12897dff1	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	2f1b1a56-b6c4-4e30-a1f7-12701aa5a535	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	7b92ac4f-50c9-4061-b4a7-535a58cea8f6	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69844-031	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-031	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-031	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-031	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-032	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-032	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-032	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-032	esomeprazole magnesium	esomeprazole magnesium	Graviti Pharmaceuticals Private Limited	ANDA	Current
70377-055	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
70377-055	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
70377-055	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
70377-055	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
70377-056	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
70377-056	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
70377-056	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
70377-056	esomeprazole magnesium	esomeprazole magnesium	Biocon Pharma Inc.,	ANDA	Current
82009-033	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-034	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Quallent Pharmaceuticals Health LLC	ANDA	Current