Application 075785

Type: ANDA
Sponsor: IMPAX LABS

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	TE codes	Approval date
A075785-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A075785-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A075785-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075785-001	AB
A075785-002	AB
A075785-003	AB

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 · 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
2026-10-15 13:18:30	2026-09	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075785-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075785-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075785-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075785-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075785-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075785-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075785-001	AB	1	`79d66fd596c7…`

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 6 of 14 · 280 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	0fb314cb-6291-422c-98ff-24d8449992f6	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
careone omeprazole	OMEPRAZOLE	Retail Business Services, LLC	063cfad8-3ca6-4b72-a4c9-512b8047bae3	2025-04-17	Warnings	Name fallback generic name: OMEPRAZOLE
leader omeprazole	OMEPRAZOLE	Cardinal Health 110, LLC. dba Leader	19beab17-ca25-4be3-bada-20a2e9aa26b5	2025-04-16	Warnings	Name fallback generic name: OMEPRAZOLE
rugby omeprazole	OMEPRAZOLE	Rugby Laboratories	61952807-f38d-4e7a-8646-a8ec85d7fb37	2025-04-15	Warnings	Name fallback generic name: OMEPRAZOLE
careone omeprazole	OMEPRAZOLE	American Sales Company	a5ec923a-dbc7-43e0-b3b8-f61dcaa6765d	2025-04-14	Warnings	Name fallback generic name: OMEPRAZOLE
signature care omeprazole	OMEPRAZOLE	Safeway	85ece978-3cfb-4c09-bf0f-3217fda8e7d4	2025-04-14	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	e87d2206-9c06-438c-947b-10b29a879d7b	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	2e5d1b21-6b32-0c8d-e063-6294a90a8431	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE MAGNESIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	8edfcc08-a14e-4579-bd44-045267de5b79	2025-04-02	Warnings	Name fallback brand name: omeprazole
omeprazole	OMEPRAZOLE	Kroger Company	083841e8-482d-4e5b-90ab-1139b576d691	2025-03-31	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	54fd9f84-9c67-4846-b79d-eb9e6720a315	2025-03-31	Warnings	Name fallback generic name: OMEPRAZOLE
Signature Care Omeprazole	OMEPRAZOLE	Safeway	c76c4235-92d4-4384-8ddc-ceed0b928c48	2025-03-31	Warnings	Name fallback generic name: OMEPRAZOLE
equate omeprazole	OMEPRAZOLE	WALMART INC.	dcfe8e94-9c88-464e-9a80-3baa9c4755d9	2025-03-27	Warnings	Name fallback generic name: OMEPRAZOLE
equate omeprazole	OMEPRAZOLE	Wal-Mart Stores Inc	504b8282-d93f-454f-9f93-84cb8a9105d7	2025-03-25	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Allegiant Health	3344c589-c4ac-4f2d-8d32-828db4e825a6	2025-03-19	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	30955530-56d2-174d-e063-6294a90a413c	2025-03-06	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	CVS Pharmacy	01bde9ca-0114-426d-8188-c55aefaa0961	2025-03-05	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	H E B	501d80c0-68ee-4fd9-bc56-0b214dbf72b5	2025-02-27	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	40f66cac-bc23-43f9-9966-87cce458c996	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Asclemed USA, Inc.	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	2025-02-13	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.