Application 206877

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	TABLET, 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
A206877-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2018-06-06

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	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acid Reducer	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	a4e92bd2-8f75-4acc-9b75-df8332bd4cc4	2026-06-04	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Rugby Laboratories	33990795-e994-4307-a570-9e8e8b44c473	2026-02-04	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 0536-1322
Acid Reducer	OMEPRAZOLE	Fred's, Inc.	7f00d0ed-4b7e-7011-e053-2a91aa0a2454	2024-06-27	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 55315-996
Acid Reducer	OMEPRAZOLE	CVS Pharmacy, Inc.	3349ee88-e53b-4586-8d28-20ecf8fcb1a5	2024-06-27	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 69842-941
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	3eb70031-6439-44cf-8056-3e2e1e4a7fa9	2024-06-27	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 58602-826
Acid Reducer	OMEPRAZOLE	Family Dollar Stores, LLC	6d8daf78-1672-4bbf-a022-514bf0a5ac9a	2024-06-17	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 55319-037
Acid Reducer	OMEPRAZOLE	NORTHEAST PHARMA	35ceccb5-dc3d-4ee1-bdac-35cb52c22f59	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 80136-852
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	287ceb12-e4d8-43c7-8cec-c4d23aa8fb12	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 58602-850
Acid Reducer	OMEPRAZOLE	Cardinal Health	230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 70000-0521
Acid Reducer	OMEPRAZOLE	Bi-Mart	419659f9-098a-4a18-8bba-cd45157bfa50	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 37835-189
Acid Reducer	OMEPRAZOLE	WALGREEN CO.	b9561780-e358-b610-e053-2a95a90af020	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 0363-1008
Acid Reducer	OMEPRAZOLE	KROGER COMPANY	eb5d02a8-4112-2066-e053-2a95a90abba3	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	fde12bf8-3e3b-4813-a8c4-4385e7de8204	2024-06-14	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 58602-729
Acid Reducer	OMEPRAZOLE	Wal-Mart Stores, Inc.	1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c	2024-06-14	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 49035-983
Acid Reducer	OMEPRAZOLE	Winco Foods, LLC.	0cb2949a-baf2-4276-a27b-8f3cc4b9a658	2024-06-14	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 67091-316
AMAZON BASIC CARE OMEPRAZOLE	OMEPRAZOLE	Amazon.com Services LLC	10efef7c-bdf4-36cf-e063-6394a90a8c0f	2024-05-10	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	DISCOUNT DRUG MART	ff2c8446-9d8b-4300-b157-884b48e98bb7	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 53943-016
Acid Reducer	OMEPRAZOLE	Best Choice	43ea758b-6cea-44a2-b4d6-8f99211c8826	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 63941-006
Acid Reducer	OMEPRAZOLE	RELIABLE 1 LABORATORIES LLC	f6b13640-6c71-4c3d-8eb5-c36fca201aee	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 69618-054
Acid Reducer	OMEPRAZOLE	7-Eleven	61206416-e0c1-44d7-ad35-feb629361ba9	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 10202-722

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-1008	Acid Reducer	Omeprazole	WALGREEN CO.	ANDA	Current
0363-1008	Acid Reducer	Omeprazole	WALGREEN CO.	ANDA	Current
0536-1322	Acid Reducer	Omeprazole	Rugby Laboratories	ANDA	Current
0536-1322	Acid Reducer	Omeprazole	Rugby Laboratories	ANDA	Current
10202-722	Acid Reducer	Omeprazole	7-Eleven	ANDA	Current
10202-722	Acid Reducer	Omeprazole	7-Eleven	ANDA	Current
10202-722	Acid Reducer	Omeprazole	7-Eleven	ANDA	Current
10202-722	Acid Reducer	Omeprazole	7-Eleven	ANDA	Current
10202-722	Acid Reducer	Omeprazole	7-Eleven	ANDA	Current
37835-189	Acid Reducer	Omeprazole	Bi-Mart	ANDA	Current
37835-189	Acid Reducer	Omeprazole	Bi-Mart	ANDA	Current
37835-189	Acid Reducer	Omeprazole	Bi-Mart	ANDA	Current
49035-983	Acid Reducer	Omeprazole	Wal-Mart Stores, Inc.	ANDA	Current
49035-983	Acid Reducer	Omeprazole	Wal-Mart Stores, Inc.	ANDA	Current
49035-983	Acid Reducer	Omeprazole	Wal-Mart Stores, Inc.	ANDA	Current
49035-983	Acid Reducer	Omeprazole	Wal-Mart Stores, Inc.	ANDA	Current
53943-016	Acid Reducer	Omeprazole	DISCOUNT DRUG MART	ANDA	Current
53943-016	Acid Reducer	Omeprazole	DISCOUNT DRUG MART	ANDA	Current
53943-016	Acid Reducer	Omeprazole	DISCOUNT DRUG MART	ANDA	Current
53943-016	Acid Reducer	Omeprazole	DISCOUNT DRUG MART	ANDA	Current
55315-996	Acid Reducer	Omeprazole	Fred's, Inc.	ANDA	Current
55315-996	Acid Reducer	Omeprazole	Fred's, Inc.	ANDA	Current
55315-996	Acid Reducer	Omeprazole	Fred's, Inc.	ANDA	Current
55319-037	Acid Reducer	Omeprazole	Family Dollar, Inc.	ANDA	Current
55319-037	Acid Reducer	Omeprazole	Family Dollar, Inc.	ANDA	Current
55319-037	Acid Reducer	Omeprazole	Family Dollar, Inc.	ANDA	Current
55319-037	Acid Reducer	Omeprazole	Family Dollar, Inc.	ANDA	Current
58602-729	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-729	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-729	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-729	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-729	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-729	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-729	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-826	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-826	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-826	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-850	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-850	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
58602-850	Acid Reducer	Omeprazole	Aurohealth LLC	ANDA	Current
63941-006	Acid Reducer	Omeprazole	Best Choice	ANDA	Current
63941-006	Acid Reducer	Omeprazole	Best Choice	ANDA	Current
63941-006	Acid Reducer	Omeprazole	Best Choice	ANDA	Current
63941-006	Acid Reducer	Omeprazole	Best Choice	ANDA	Current
67091-316	Acid Reducer	Omeprazole	Winco Foods, LLC.	ANDA	Current
67091-316	Acid Reducer	Omeprazole	Winco Foods, LLC.	ANDA	Current
67091-316	Acid Reducer	Omeprazole	Winco Foods, LLC.	ANDA	Current
69618-054	Acid Reducer	Omeprazole	RELIABLE 1 LABORATORIES LLC	ANDA	Current
69618-054	Acid Reducer	Omeprazole	RELIABLE 1 LABORATORIES LLC	ANDA	Current
69842-941	Acid Reducer	Omeprazole	CVS Pharmacy, Inc.	ANDA	Current
69842-941	Acid Reducer	Omeprazole	CVS Pharmacy, Inc.	ANDA	Current
69842-941	Acid Reducer	Omeprazole	CVS Pharmacy, Inc.	ANDA	Current
70000-0521	Acid Reducer	Omeprazole	Cardinal Health	ANDA	Current
70000-0521	Acid Reducer	Omeprazole	Cardinal Health	ANDA	Current
70000-0521	Acid Reducer	Omeprazole	Cardinal Health	ANDA	Current
70000-0521	Acid Reducer	Omeprazole	Cardinal Health	ANDA	Current
80136-852	Acid Reducer	Omeprazole	NORTHEAST PHARMA	ANDA	Current
80136-852	Acid Reducer	Omeprazole	NORTHEAST PHARMA	ANDA	Current
80136-852	Acid Reducer	Omeprazole	NORTHEAST PHARMA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50994	ORIG	2018-01-08