Application 205070

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 43.

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
A205070-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29
A205070-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29
A205070-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205070-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205070-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205070-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2018-06-29	`301d65b070ca…`

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	A205070-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205070-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205070-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205070-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205070-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205070-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205070-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205070-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205070-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205070-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205070-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205070-003	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 5 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	43090803-37de-77e3-e063-6294a90a8c43	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Family Dollar (FAMILY WELLNESS)	f2195d73-1fd5-4de2-aa5c-18741d11f4fc	2025-10-30	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	e235ef89-3592-4ca1-8c13-d7ce84b1001c	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	530a8a66-48ad-474f-b170-c6fac95753ec	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	ed9895ae-3d18-434c-8b56-47bccdc8fe6d	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals, Inc.	28515ff8-379d-5356-e063-6394a90af3f3	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Major Pharmaceuticals	afda9d2c-b141-4c32-a5b4-e850974b30a3	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	aa8fc2ea-3942-453b-bc19-1e4b14ba6926	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3724b8f7-52ff-a5f8-e063-6294a90acf20	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
dg health omeprazole	OMEPRAZOLE	Dolgencorp, LLC	326bf21c-fad4-473e-9e7f-797319d4353a	2025-09-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3d6e07d1-38b1-f2ab-e063-6294a90a34ac	2025-08-28	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	bab55f83-ba03-49a0-842a-19c9976b7fe8	2025-08-28	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	5bda70ae-c3f6-450b-892f-6814795dd6ca	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	8090d4c3-3184-7812-53d7-aa30e14b79d1	2025-08-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Golden State Medical Supply, Inc.	ded71262-d17f-3799-e053-2995a90a5427	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3b19d724-821b-61dc-e063-6294a90aa4d3	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3a9baece-03be-6c77-e063-6394a90a7032	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Golden State Medical Supply, Inc.	f873dc20-c817-5e4f-e053-6394a90a04f2	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Cardinal Health 107, LLC	fbd71fd8-3f36-46a1-bc76-53f6820d42a2	2025-06-05	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.