Application 078490

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	No	No
002	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	No	No
003	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	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
A078490-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17
A078490-002	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16
A078490-003	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078490-001	AB
A078490-002	AB
A078490-003	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	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`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	A078490-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078490-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	a806da8c-5f84-454d-966c-da1c48710f80	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	AvPAK	f77efc97-2565-38ab-e053-6394a90aebda	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole DR	OMEPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	b4cd8ed1-d9d3-5b57-e053-2995a90a9f3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490 ndc (product): 80425-0109
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	59d8be3f-ba13-4897-9ceb-f8ac6ccc1624	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	487ff32f-943e-458b-b898-bd7b0290cc49	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	c8f2e604-74fa-4205-b41f-32401e2dc59e	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a656a059-2b1a-44b3-85f8-af278032b54c	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8f13fd38-dc73-4072-bdc9-9474704a4121	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490

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 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-123	Omeprazole	Omeprazole	NorthStar Rx LLC	ANDA	Current
16714-123	Omeprazole	Omeprazole	NorthStar Rx LLC	ANDA	Current
16714-123	Omeprazole	Omeprazole	NorthStar Rx LLC	ANDA	Current
16714-123	Omeprazole	Omeprazole	NorthStar Rx LLC	ANDA	Current
16714-634	Omeprazole	Omeprazole	NorthStar Rx LLC	ANDA	Current
55111-643	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-643	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-643	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-643	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-643	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-643	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-643	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-644	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-644	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-644	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-644	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-644	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-644	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-644	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-645	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-645	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-645	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-645	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-645	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-645	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-645	Omeprazole	Omeprazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55700-410	Omeprazole	Omeprazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-410	Omeprazole	Omeprazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-410	Omeprazole	Omeprazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-410	Omeprazole	Omeprazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60687-608	Omeprazole	Omeprazole	American Health Packaging	ANDA	Current
60687-608	Omeprazole	Omeprazole	American Health Packaging	ANDA	Current
68071-1943	Omeprazole	Omeprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2741	Omeprazole	Omeprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
72789-257	Omeprazole	Omeprazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
80425-0109	Prilosec	Omeprazole 40mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0109	Omeprazole	Omeprazole	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0109	Omeprazole	Omeprazole	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0109	Omeprazole	Omeprazole	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
82009-023	Omeprazole	Omeprazole	Quallent Pharmaceuticals Health LLC	ANDA	Current