Application 091352

Type: ANDA
Sponsor: ZYDUS PHARMS USA 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 42.

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
A091352-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19
A091352-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19
A091352-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091352-001	AB
A091352-002	AB
A091352-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091352-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091352-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091352-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091352-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-001	AB	1	`1e350fbaab3a…`

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Major Pharmaceuticals	afda9d2c-b141-4c32-a5b4-e850974b30a3	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352 ndc (product): 0904-6917
Omeprazole	OMEPRAZOLE	Cardinal Health 107, LLC	fbd71fd8-3f36-46a1-bc76-53f6820d42a2	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352 ndc (product): 55154-2332
Omeprazole	OMEPRAZOLE	Zydus Lifesciences Limited	2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2	2024-12-03		Exact identifier application applno (ANDA): 091352 application number: ANDA091352 ndc (product): 65841-761 ndc (product): 65841-759 ndc (product): 65841-760
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	9724601b-bb12-4eb2-bc2e-0532976bf5d1	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	0ef8d55f-6cae-4b58-844b-968d8e5b8c24	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	1c99e189-93c0-4461-82c2-4521e6c4d514	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	39e3b45a-8e9b-49d6-976a-6668f4e27649	2023-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	Zydus Pharmaceuticals USA Inc.	9c22ceb2-2c34-43c3-9a35-2589c9078741	2023-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352 ndc (product): 68382-500 ndc (product): 68382-411 ndc (product): 68382-412

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6917	Omeprazole	Omeprazole	Major Pharmaceuticals	ANDA	Current
0904-6917	Omeprazole	Omeprazole	Major Pharmaceuticals	ANDA	Current
0904-6917	Omeprazole	Omeprazole	Major Pharmaceuticals	ANDA	Current
55154-2332	Omeprazole	Omeprazole	Cardinal Health	ANDA	Current
55154-2332	Omeprazole	Omeprazole	Cardinal Health	ANDA	Current
55154-2332	Omeprazole	Omeprazole	Cardinal Health	ANDA	Current
55154-2332	Omeprazole	Omeprazole	Cardinal Health 107, LLC	ANDA	Current
55154-2332	Omeprazole	Omeprazole	Cardinal Health	ANDA	Current
65841-759	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-759	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-759	Omeprazole	Omeprazole	Zydus Lifesciences Limited	ANDA	Current
65841-759	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-760	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-760	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-760	Omeprazole	Omeprazole	Zydus Lifesciences Limited	ANDA	Current
65841-760	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-761	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-761	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
65841-761	Omeprazole	Omeprazole	Zydus Lifesciences Limited	ANDA	Current
65841-761	Omeprazole	Omeprazole	Cadila Healthcare Limited	ANDA	Current
68382-411	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-411	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-411	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-411	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-411	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-411	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-411	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-412	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-412	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-412	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-412	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-412	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-412	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-412	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-500	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-500	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-500	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-500	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-500	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-500	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-500	Omeprazole	Omeprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current