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 3 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply, Inc.	f27b3518-d5c1-1229-e053-2a95a90ab56f	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: OMEPRAZOLE generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	4f5c91e6-6377-ca94-e063-6294a90a2f99	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	61eab342-61fd-471f-8f70-95f9cbca0097	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
OMEPRAZOLE	OMEPRAZOLE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6479415a-ffb0-4d20-ad00-f091c8aaaadb	2026-03-31	Warnings	Name fallback brand name: OMEPRAZOLE generic name: OMEPRAZOLE
OMEPRAZOLE	OMEPRAZOLE	Walgreen Company	97eaf0dc-380b-4039-aeb7-dde39942a9d6	2026-03-31	Warnings	Name fallback brand name: OMEPRAZOLE generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Walgreens	b9683a94-fd44-4364-be0e-477ca1a29aba	2026-03-27	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Rite Aid Corporation	ee853401-b641-4dab-b708-29424c2d0b79	2026-03-25	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Walmart Inc.	5168ccd9-31b4-3a49-85b9-4f202cd99f6b	2026-03-19	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	c1276463-7357-45b5-9f7e-8d3c4a550ff4	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	df1a4294-3893-4a11-b4d5-f3536678087e	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Little Pharma, Inc.	d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f	2026-03-16	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole DR	OMEPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	c8bf92c9-1bab-7985-e053-2995a90a0225	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	af707c0a-5193-3f83-e053-2995a90a78ef	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	e07af8c9-559c-5a93-e053-2a95a90a2c63	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Meijer, Inc.	47c41c68-cb20-40f0-9d85-ea8db3328478	2026-03-06	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Dr. Reddy's Laboratories Limited	603d2d06-c5e8-4378-a422-8dca1a410af7	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Rugby Laboratories	33990795-e994-4307-a570-9e8e8b44c473	2026-02-04	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	HyVee Inc	a5df7dac-00f4-4d97-9586-cde3055890ac	2026-02-04	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	HyVee Inc	fd22d4df-9679-4c2d-9bc4-3619288fb4cc	2026-02-01	Warnings	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 · 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