Application 204152

Type: ANDA
Sponsor: PERRIGO R AND D

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
A204152-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2015-07-30

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	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204152-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2015-07-30	`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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	37291cab-e350-d8e3-e063-6294a90a9cb1	2026-07-29	Warnings	Name fallback generic name: OMEPRAZOLE MAGNESIUM
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	77ed80a2-a482-4838-ac55-4865b5c31d9f	2025-10-01	Warnings	Name fallback generic name: OMEPRAZOLE MAGNESIUM
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	35a79458-79f6-44d6-b74c-b4f4aaf0dde0	2025-10-01	Warnings	Name fallback generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Gericare Pharmaceuticals	0e1f5d7c-5956-3be7-e054-00144ff8d46c	2025-07-28	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	HEB	5d8b3f5f-f680-64ae-b360-c0bd06b2ac92	2025-07-23	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	CVS Health Corp.	3bbfa87d-f8b7-19bd-9f12-39cba31ae0b3	2025-07-23	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Chain Drug Marketing Association	ab5d339b-2c02-611d-d5db-8e1891684fe0	2025-07-23	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Acid Reducer	OMEPRAZOLE MAGNESIUM	LEADER/ Cardinal Health 110, Inc.	1dc00f13-d1f5-15a0-32cc-4fc041865e72	2025-07-23	Warnings	Name fallback generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Albertsons Companies	302b1332-181b-834b-4154-d849cb3a1ef0	2025-07-23	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Discount Drug Mart, Inc	daeeba93-29d5-efb4-a591-3e72c4e50341	2025-07-23	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES	The Kroger Co.	8a6bbc31-7c50-a730-4233-e346fd7eb5ba	2025-07-22	Warnings	Name fallback brand name: Omeprazole Magnesium
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc.	fe0eb905-2042-aed1-a67d-a219e76f679b	2025-07-22	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Walgreens Company	ee8b1740-9bcf-5b70-bd8d-97f98303dc72	2025-07-22	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES	Wal-Mart Stores Inc	3160e212-9ee9-8316-f51e-4628862f654c	2025-07-22	Warnings	Name fallback brand name: Omeprazole Magnesium
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Chain Drug Consortium, LLC	39ac65c0-d957-125f-f00b-e3846a437489	2025-07-22	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Chain Drug Marketing Association	fdf1259b-e9d3-70a9-c209-e2eb6b152841	2025-07-22	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	c7229a69-07e7-4690-8fc0-1f0f093bf230	2025-06-10	Warnings	Name fallback generic name: OMEPRAZOLE MAGNESIUM
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Limited	0e8fde83-a55c-edaf-3c66-e1fc77d0bc11	2025-05-28	Warnings	Name fallback brand name: Omeprazole Magnesium generic name: OMEPRAZOLE MAGNESIUM
omeprazole	OMEPRAZOLE MAGNESIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	8edfcc08-a14e-4579-bd44-045267de5b79	2025-04-02	Warnings	Name fallback generic name: OMEPRAZOLE MAGNESIUM
equate omeprazole	OMEPRAZOLE MAGNESIUM	WALMART INC.	6790b6c8-c258-4dfb-a400-25dc2812971f	2025-03-26	Warnings	Name fallback generic name: OMEPRAZOLE MAGNESIUM

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0045	Good Sense omeprazole	Omeprazole magnesium	L. Perrigo Company	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10302	ORIG	2015-08-03