Application 075876

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	No	No
002	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	No	No
003	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075876-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21

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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2003-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075876-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075876-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075876-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075876-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075876-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075876-003	AB	1	`ea99ee380514…`

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 14 · 280 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Amazon.com Services LLC	94faa721-e925-4033-8661-d1990dfa920d	2026-08-30	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	63b3982a-b541-4b0d-99d4-93a673e57d46	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
AMAZON BASIC CARE OMEPRAZOLE	OMEPRAZOLE	Amazon.com Services LLC	10efef7c-bdf4-36cf-e063-6394a90a8c0f	2026-08-28	Warnings	Name fallback generic name: OMEPRAZOLE
good now omeprazole	OMEPRAZOLE	Gobrands, Inc	0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f	2026-08-19	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Discount Drug Mart, Inc	4d5f30c2-775d-a1a3-e063-6394a90a07ff	2026-08-12	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
OMEPRAZOLE	OMEPRAZOLE	H E B	4eb05eb3-be59-4132-95a8-5a8f5065d758	2026-08-10	Warnings	Name fallback brand name: OMEPRAZOLE generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	ded0df8b-1813-4595-ac2b-5499704bfd48	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	6ea9a6f3-b756-4cdf-b3db-f666a2c17d66	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	062800b1-790a-41c3-a8be-94143d2c7fb6	2026-08-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	96104ea6-c08f-40b5-83f5-d840b317f1fd	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	a19ce586-59b7-4c2e-9e8d-12e8f0f058e2	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0344268f-d8e6-48d5-b1e1-f750ed1d8a52	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	P & L Development, LLC	883e428a-e157-4bbf-8657-e7a93dc99e8c	2026-07-14	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	WALMART INC. (see also Equate)	d3c1ba08-680d-4e39-875c-1f1d42ae787c	2026-07-13	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	HAWAII REPACK, INC.	9359e826-5263-44fc-8dd3-9d0852fe42d6	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	dcaadc8c-32d1-476f-b821-973c012b7fa7	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
careone omeprazole	OMEPRAZOLE	American Sales Company	5b88717a-e90c-4e74-ae2a-29270e14a3cc	2026-07-08	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE MAGNESIUM	YYBA CORP	535c2543-84f3-f5c1-e063-6394a90adb1e	2026-07-07	Warnings	Name fallback brand name: Omeprazole
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	4c0cf466-f9e8-390e-e063-6294a90a2ed8	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Unit Dose Solutions, Inc.	557d4c2c-5541-3a51-e063-6394a90ad278	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5211	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5222	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6150	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
10544-295	Omeprazole	omeprazole	Blenheim Pharmacal, Inc.	ANDA	Current
10544-299	Omeprazole	omeprazole	Blenheim Pharmacal, Inc.	ANDA	Current
35356-811	Omeprazole	Omeprazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
51079-007	Omeprazole	omeprazole	Mylan Institutional Inc.	ANDA	Current
52959-722	Omeprazole	Omeprazole	H.J. Harkins Company, Inc.	ANDA	Current
53808-0746	Omeprazole	omeprazole	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5681	Omeprazole	omeprazole	Cardinal Health	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-271	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-271	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
63629-2607	Omeprazole	omeprazole	Bryant Ranch Prepack	ANDA	Current
63629-2607	Omeprazole	omeprazole	Bryant Ranch Prepack	ANDA	Current
66336-706	Omeprazole	omeprazole	Dispensing Solutions, Inc.	ANDA	Current