Application 075347

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

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	TE codes	Approval date
A075347-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30
A075347-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30
A075347-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075347-001	AB
A075347-002	AB
A075347-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075347-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075347-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075347-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2008-05-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075347-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075347-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075347-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075347-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075347-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075347-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075347-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075347-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075347-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075347-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075347-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075347-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075347-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075347-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075347-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075347-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075347-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075347-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075347-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075347-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075347-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075347-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075347-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075347-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075347-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075347-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075347-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075347-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075347-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075347-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075347-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075347-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075347-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075347-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075347-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075347-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075347-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075347-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075347-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075347-001	AB	1	`301d65b070ca…`

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 2 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
GOOD SENSE OMEPRAZOLE	OMEPRAZOLE	L. Perrigo Company	b840439b-540b-465a-8faa-f7b1024c628e	2026-06-29	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	d9c8a242-bdba-4f92-8629-692b47ebba21	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	71add294-ff24-4bbf-9067-7c56ed7c9f1a	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	e67bf2c6-0618-48e0-aa08-705501d86431	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	db9f071b-85f4-061f-e053-2995a90a3ff5	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	6a1aeb95-5760-4363-816a-fa8305979c50	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	P & L Development, LLC	911a08c4-ba73-4600-a5f2-7f26ba8c8604	2026-06-25	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	d9b3918c-a66e-4277-8b8f-b7ece93fa7db	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	1eb57c13-25ed-70bc-e063-6294a90afdac	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	QPharma Inc	50115204-74f7-17c1-e063-6394a90ab665	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	a4e92bd2-8f75-4acc-9b75-df8332bd4cc4	2026-06-04	Warnings	Name fallback generic name: OMEPRAZOLE
Berkley and Jensen Omeprazole	OMEPRAZOLE	BJWC	f74752a8-a686-4c7d-91ad-8c87c4596a7a	2026-05-21	Warnings	Name fallback generic name: OMEPRAZOLE
OMEPRAZOLE	OMEPRAZOLE	Safeway	b3ec4a44-5643-4438-b41b-e04946436719	2026-05-18	Warnings	Name fallback brand name: OMEPRAZOLE generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Amazon.com Services LLC	7e0d319c-6917-45c4-b7e1-e870fc3fcea5	2026-05-13	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	QPharma Inc	f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole Delayed-Release	OMEPRAZOLE	H-E-B	448ba584-6a6e-3d85-e063-6294a90a5579	2026-04-29	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Preferred Phharmaceuticals Inc.	319d990e-161b-4c16-b026-f55c413c7e8f	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	AMERISOURCEBERGEN DRUG CORPORATION	0521c51b-d113-7e35-f1a6-c4495a2bcfcc	2026-04-17	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
care one omeprazole	OMEPRAZOLE	American Sales Company	db2d75ea-5924-4b7f-a92d-d4847a010d52	2026-04-17	Warnings	Name fallback 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60429-899	Omeprazole	Omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
64205-620	Omeprazole	Omeprazole	ReadyMeds	ANDA	Current
64205-640	Omeprazole	Omeprazole	ReadyMeds	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42981	ORIG	2004-12-07
8627	ORIG	2004-06-10
30857	ORIG	2001-11-16