Application 078003

Type: ANDA
Sponsor: IVAX SUB TEVA 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 43.

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
A078003-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2015-01-26
A078003-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2015-01-26

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078003-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078003-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-01-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078003-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078003-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078003-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078003-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078003-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078003-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078003-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078003-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078003-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078003-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078003-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078003-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078003-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078003-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078003-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078003-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078003-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078003-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078003-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078003-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078003-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078003-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078003-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078003-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078003-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078003-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078003-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078003-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078003-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078003-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078003-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078003-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078003-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078003-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078003-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078003-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078003-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078003-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078003-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078003-002	AB	1	`c0c555d07b60…`

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 4 of 9 · 170 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy	0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb	2025-08-30	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Amerisource Bergen	3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46	2025-08-30	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	PD-Rx Pharmaceuticals, Inc.	ac12cd05-10cf-4694-a9e8-e5f04fe162a7	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Ascend Laboratories, LLC	277ce748-2809-4be0-81e7-6a4d604f2c6f	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium
Up and Up Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Target Corporation	b3d3ad1d-96f8-4f72-ae66-f14940a62882	2025-06-02	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	b594f052-b6be-4d3b-9316-29cab050344a	2025-05-20	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	2879c79f-bf2a-0bc9-e063-6394a90a98ae	2025-04-28	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	LEADER/ CARDINAL HEALTH 110, INC.	c98b4332-ce47-422e-be54-f3eee0762354	2025-04-24	Warnings	Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium Delayed Release	ESOMEPRAZOLE MAGNESIUM	WALGREENS	2fa5d747-a014-2475-e063-6294a90ab918	2025-04-21	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	3c7a6b13-c67d-48f7-b170-1437a420d704	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	e691b51e-2e31-4408-81c4-5afec6f9bbb6	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	2d21ed0b-a089-46f4-9ebb-f24f9f3af61d	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	7038a0bc-99b2-4a6e-9b9a-0646ec187706	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Camber Consumer Care Inc	d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	2025-04-05	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	f4ae091d-9b74-4a0e-ac68-057effd91e17	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	5647bfb0-6af0-4580-b202-0f1fc9c41265	2025-03-13	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Quallent Pharmaceuticals Health LLC	7362f930-0879-451e-8de9-8bb8565bfb7e	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Biocon Pharma Inc.,	66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Publix	c45fd180-9d81-41e0-b7f8-025b8f29763a	2025-02-21	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	fe7d7aa8-4f46-83ae-e053-6394a90a01d6	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM

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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-6450	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6450	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6450	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6450	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6450	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6451	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6451	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6451	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6451	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6451	Esomeprazole Magnesium	Esomeprazole Magnesium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42708-024	Esomeprazole Magnesium	Esomeprazole Magnesium	QPharma Inc	ANDA	Current
42708-024	Esomeprazole Magnesium	Esomeprazole Magnesium	QPharma Inc	ANDA	Current
42708-024	Esomeprazole Magnesium	Esomeprazole Magnesium	QPharma Inc	ANDA	Current
50436-3120	Esomeprazole Magnesium	Esomeprazole Magnesium	Unit Dose Services	ANDA	Current
59088-701	PharmapureRx ESOMEP-EZS	esomeprazole magnesium	PureTek Corporation	ANDA	Current
61919-243	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	DIRECT RX	ANDA	Current
61919-243	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57222	ORIG	2019-01-15
39547	ORIG	2015-02-17
9107	ORIG	2015-01-28