Application 207891

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	TABLET, DELAYED RELEASE;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207891-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL			2018-10-12

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`cb3db0bc1861…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
omeprazole	OMEPRAZOLE	Little Pharma, Inc.	d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f	2026-03-16	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 72559-014
Omeprazole	OMEPRAZOLE	Redpharm Drug	44f59d88-d401-950b-e063-6294a90a2a50	2025-12-02	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	Sun Pharmaceutical Industries, Inc.	51c3ef34-b7c1-419e-a784-ae82540c7a22	2025-04-28	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 62756-377
Omeprazole	OMEPRAZOLE	BI-MART	fb089d15-daa4-477a-be83-ecd55c3283d4	2025-04-03	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 37835-001
Omeprazole	OMEPRAZOLE	GERI-CARE PHARMACEUTICALS, CORP	8a77aea7-912e-43a3-bce3-f666b9b9c9bc	2024-11-22	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
omeprazole	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	7535a309-1a67-4f50-911b-7cf570322931	2024-10-30	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 57483-840
Omeprazole	OMEPRAZOLE	Living Better Brands LLC	1d500e2d-395b-437e-a95c-3922a71a0956	2024-08-12	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	OHM LABORATORIES INC.	35a95bec-51b9-465b-aa93-ad26afb87be8	2024-02-29	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 51660-029
Omeprazole	OMEPRAZOLE	VALU MERCHANDISERS COMPANY	7b2d41b6-3e36-4973-b5f6-adf9b828f40d	2023-12-13	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	STRATEGIC SOURCING SERVICES LLC	56380ccc-6fc2-4e1b-bd87-da24c9aa31cd	2023-08-14	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
omeprazole	OMEPRAZOLE	THE KROGER COMPANY	f55cedc7-e0bc-4d30-af52-bfa881f6adde	2023-01-06	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 30142-992
Omeprazole	OMEPRAZOLE	Twin Med LLC	346141b5-b49d-489a-84eb-18df8b940460	2023-01-06	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 55681-306
Omeprazole	OMEPRAZOLE	HARRIS TEETER	c618964f-4b16-448e-851b-e6b2a816c660	2022-12-27	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 72036-981
Omeprazole	OMEPRAZOLE	Strategic Sourcing Services	dfa91081-3917-4dfc-9789-76800f57bb31	2022-05-11	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 70677-0148

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30142-992	omeprazole	omeprazole	THE KROGER COMPANY	ANDA	Current
30142-992	omeprazole	omeprazole	THE KROGER COMPANY	ANDA	Current
37835-001	Omeprazole	Omeprazole	BI-MART	ANDA	Current
51660-029	Omeprazole	Omeprazole	OHM LABORATORIES INC.	ANDA	Current
51660-029	Omeprazole	Omeprazole	OHM LABORATORIES INC.	ANDA	Current
51660-029	Omeprazole	Omeprazole	OHM LABORATORIES INC.	ANDA	Current
51660-029	Omeprazole	Omeprazole	OHM LABORATORIES INC.	ANDA	Current
51660-029	Omeprazole	Omeprazole	OHM LABORATORIES INC.	ANDA	Current
51660-029	Omeprazole	Omeprazole	OHM LABORATORIES INC.	ANDA	Current
55681-306	Omeprazole	OMEPRAZOLE	Twin Med LLC	ANDA	Current
55681-306	Omeprazole	OMEPRAZOLE	Twin Med LLC	ANDA	Current
57483-840	omeprazole	omeprazole	INNOVUS PHARMACEUTICALS, INC.	ANDA	Current
62756-377	Omeprazole	Omeprazole	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-377	Omeprazole	Omeprazole	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-377	Omeprazole	Omeprazole	Sun Pharmaceutical Industries, Inc.	ANDA	Current
70677-0148	Omeprazole	Omeprazole	Strategic Sourcing Services	ANDA	Current
72036-981	Omeprazole	OMEPRAZOLE	HARRIS TEETER	ANDA	Current
72036-981	Omeprazole	OMEPRAZOLE	HARRIS TEETER	ANDA	Current
72559-014	omeprazole	omeprazole	Little Pharma, Inc.	ANDA	Current
72559-014	omeprazole	omeprazole	Little Pharma, Inc.	ANDA	Current
72559-014	omeprazole	omeprazole	Little Pharma, Inc.	ANDA	Current
72559-014	omeprazole	omeprazole	Little Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56473	ORIG	2018-11-15