Application 207673

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 RELEASE;ORAL	EQ 20MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207673-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2018-05-15

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`cb3db0bc1861…`

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
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Walgreens Company	f97f8604-9f00-6ed5-ae25-fedc8cf36a5d	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673 ndc (product): 0363-3298
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CHAIN DRUG MARKETING ASSOCIATION INC	f95053ab-d6c5-ee92-58d1-6f203873f79c	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673 ndc (product): 63868-425
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	HEB	e3747f1e-01e7-f3cf-499e-c7c3f6d06a30	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673 ndc (product): 37808-115
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc.	945beb4b-8a31-d904-8881-1cf839604347	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673 ndc (product): 43598-812
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	The Kroger Co.	b4cdf878-61d3-01bd-48c9-4d6f4fbc71df	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673 ndc (product): 30142-261
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Discount Drug Mart, Inc	0d6e66c5-ca6d-5cda-72d7-9350dbd1eba0	2024-12-16	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673 ndc (product): 53943-527
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	cb8297ad-ce1b-aa31-2488-5a38b2dbc774	2022-09-30	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673 ndc (product): 43598-407

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-3298	Esomeprazole Magnesium	Esomeprazole Magnesium	Walgreens Company	ANDA	Current
0536-1230	Esomeprazole Magnesium	Esomeprazole Magnesium	RUGBY LABORATORIES	ANDA	Current
0536-1230	Esomeprazole Magnesium	Esomeprazole Magnesium	RUGBY LABORATORIES	ANDA	Current
11822-8862	Esomeprazole Magnesium	Esomeprazole Magnesium	Rite Aid Corporation	ANDA	Current
30142-261	Esomeprazole Magnesium	Esomeprazole Magnesium	The Kroger Co.	ANDA	Current
30142-261	Esomeprazole Magnesium	Esomeprazole Magnesium	The Kroger Co.	ANDA	Current
30142-261	Esomeprazole Magnesium	Esomeprazole Magnesium	The Kroger Co.	ANDA	Current
37808-115	Esomeprazole Magnesium	Esomeprazole Magnesium	HEB	ANDA	Current
37808-115	Esomeprazole Magnesium	Esomeprazole Magnesium	HEB	ANDA	Current
43598-407	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-407	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-407	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc	ANDA	Current
43598-812	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-812	Esomeprazole Magnesium	Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc.	ANDA	Current
53943-527	Esomeprazole Magnesium	Esomeprazole Magnesium	Discount Drug Mart, Inc	ANDA	Current
63868-425	Esomeprazole Magnesium	Esomeprazole Magnesium	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-425	Esomeprazole Magnesium	Esomeprazole Magnesium	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
69618-056	Esomeprazole	Esomeprazole	Reliable 1 Laboratories	ANDA	Current
69618-056	Esomeprazole	Esomeprazole	Reliable 1 Laboratories	ANDA	Current
69842-277	Esomeprazole Magnesium	Esomeprazole Magnesium	CVS Pharmacy	ANDA	Current
69842-277	Esomeprazole Magnesium	Esomeprazole Magnesium	CVS Pharmacy	ANDA	Current
69842-277	Esomeprazole Magnesium	Esomeprazole Magnesium	CVS Pharmacy	ANDA	Current
70000-0032	Esomeprazole Magnesium	Esomeprazole Magnesium	CARDINAL HEALTH	ANDA	Current
70000-0032	Esomeprazole Magnesium	Esomeprazole Magnesium	CARDINAL HEALTH	ANDA	Current
70000-0032	Esomeprazole Magnesium	Esomeprazole Magnesium	CARDINAL HEALTH	ANDA	Current
71713-202	Esomeprazole Magnesium	Esomeprazole Magnesium	Thirty Madison Inc	ANDA	Current
71713-202	Esomeprazole Magnesium	Esomeprazole Magnesium	Thirty Madison Inc	ANDA	Current