Application 078279

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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
A078279-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-09-25
A078279-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078279-001	AB
A078279-002	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 3 · 82 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	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078279-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078279-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078279-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078279-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078279-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078279-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078279-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078279-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078279-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078279-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078279-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078279-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078279-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078279-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078279-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078279-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078279-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078279-002	AB	1	`782e0a99824c…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	a9d05a38-08db-4710-b6f3-20c92ce885d5	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	AvPAK	4db9f4b8-b6df-f6e9-e063-6294a90a9f60	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals, Inc.	463c9b3b-dd6b-7ee7-e063-6394a90afb43	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	PD-Rx Pharmaceuticals, Inc.	fdea1f5f-b717-4d49-8d70-0b373c959bf0	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	2879c79f-bf2a-0bc9-e063-6394a90a98ae	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Major Pharmaceuticals	ba65c73d-fc7d-491e-aaaa-cf45a7783395	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279 ndc (product): 0904-6581
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Medsource Pharmaceuticals	1278cf6f-cc7a-462b-e063-6394a90a34e5	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	71956762-d2f7-4763-9afe-1ca8f32a3cbb	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279 ndc (product): 50090-5134
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	99fceec8-59a2-485f-a7f3-7c5afd98401d	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	15023261-51c8-2388-3439-48dace49ec02	2023-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279 ndc (product): 43598-510 ndc (product): 43598-509
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NorthStar Rx LLC	380da8db-bfa3-8c0c-f8f3-573675fed981	2023-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279 ndc (product): 16714-979 ndc (product): 16714-980
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	e5540d90-0b6e-4519-9272-c6e96730967b	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279 ndc (product): 63187-964
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	9224142a-6e14-4ca3-9e72-506ff9fbd0e1	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279 ndc (product): 71205-143

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6580	Esomeprazole Magnesium	Esomeprazole Magnesium	Major Pharmaceuticals	ANDA	Current
0904-6581	Esomeprazole Magnesium	Esomeprazole Magnesium	Major Pharmaceuticals	ANDA	Current
0904-6581	Esomeprazole Magnesium	Esomeprazole Magnesium	Major Pharmaceuticals	ANDA	Current
0904-6581	Esomeprazole Magnesium	Esomeprazole Magnesium	Major Pharmaceuticals	ANDA	Current
16714-979	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
16714-979	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
16714-979	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
16714-979	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
16714-980	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
16714-980	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
16714-980	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
16714-980	Esomeprazole Magnesium	Esomeprazole Magnesium	NorthStar Rx LLC	ANDA	Current
43598-509	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-509	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-509	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-509	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-510	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-510	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-510	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-510	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
50090-2943	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
50090-3023	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
50090-3023	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
50090-3023	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
50090-3023	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
50090-5134	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
50090-5134	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
55111-492	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-493	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Limited	ANDA	Current
60687-235	Esomeprazole Magnesium	Esomeprazole Magnesium	American Health Packaging	ANDA	Current
60687-246	Esomeprazole Magnesium	Esomeprazole Magnesium	American Health Packaging	ANDA	Current
61919-834	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	DirectRX	ANDA	Current
63187-964	Esomeprazole Magnesium	Esomeprazole Magnesium	Proficient Rx LP	ANDA	Current
63187-964	Esomeprazole Magnesium	Esomeprazole Magnesium	Proficient Rx LP	ANDA	Current
63187-964	Esomeprazole Magnesium	Esomeprazole Magnesium	Proficient Rx LP	ANDA	Current
63187-964	Esomeprazole Magnesium	Esomeprazole Magnesium	Proficient Rx LP	ANDA	Current
68071-4825	Esomeprazole Magnesium	Esomeprazole Magnesium	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4825	Esomeprazole Magnesium	Esomeprazole Magnesium	NuCare Pharmceuticals,Inc.	ANDA	Current
70518-3044	Esomeprazole Magnesium	Esomeprazole Magnesium	REMEDYREPACK INC.	ANDA	Current
70518-3044	Esomeprazole Magnesium	Esomeprazole Magnesium	REMEDYREPACK INC.	ANDA	Current
71205-143	Esomeprazole Magnesium	Esomeprazole Magnesium	Proficient Rx LP	ANDA	Current
71205-143	Esomeprazole Magnesium	Esomeprazole Magnesium	Proficient Rx LP	ANDA	Current
71205-143	Esomeprazole Magnesium	Esomeprazole Magnesium	Proficient Rx LP	ANDA	Current
71335-0709	Esomeprazole Magnesium	Esomeprazole Magnesium	Bryant Ranch Prepack	ANDA	Current
76519-1173	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	H.J. Harkins Company, Inc.	ANDA	Current
76519-1173	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	H.J. Harkins Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39555	ORIG	2015-11-25
9137	ORIG	2015-10-02