Application 207476

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	20MG;1.1GM	No	No
002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	40MG;1.1GM	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-12-06
A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207476-001	AB
A207476-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207476-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207476-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207476-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207476-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207476-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207476-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207476-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207476-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207476-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207476-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207476-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207476-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207476-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207476-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207476-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207476-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207476-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207476-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207476-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207476-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207476-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207476-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207476-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207476-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207476-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207476-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207476-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207476-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207476-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207476-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207476-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207476-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207476-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207476-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207476-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207476-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207476-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207476-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207476-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207476-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole/Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Proficient Rx LP	4d642036-7175-4f29-9f07-dbd282231d4a	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207476 application number: ANDA207476 ndc (product): 71205-984 ndc (product): 71205-985
Omeprazole/Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Westminster Pharmaceuticals, LLC	d69c2f0f-4e8b-422a-8aaf-a825998b04e0	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207476 application number: ANDA207476 ndc (product): 69367-195 ndc (product): 69367-196
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	ScieGen Pharmaceuticals, Inc.	a107804e-b308-4e79-9447-07d93016f70f	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207476 application number: ANDA207476 ndc (product): 50228-364 ndc (product): 50228-363
omeprazole sodium bicarbonate	OMEPRAZOLE SODIUM BICARBONATE	Cipla USA Inc.	9cdde58a-ae8a-451f-92cf-cab178e4ba92	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207476 application number: ANDA207476 ndc (product): 69097-913 ndc (product): 69097-914

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-585	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	AvKARE, Inc.	ANDA	Current
42291-585	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	AvKARE	ANDA	Current
50228-363	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-363	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-363	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-363	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-363	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-364	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-364	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-364	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-364	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-364	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	ANDA	Current
69097-913	omeprazole sodium bicarbonate	omeprazole sodium bicarbonate	Cipla USA Inc.	ANDA	Current
69097-913	omeprazole sodium bicarbonate	omeprazole sodium bicarbonate	Cipla USA Inc.	ANDA	Current
69097-914	omeprazole sodium bicarbonate	omeprazole sodium bicarbonate	Cipla USA Inc.	ANDA	Current
69097-914	omeprazole sodium bicarbonate	omeprazole sodium bicarbonate	Cipla USA Inc.	ANDA	Current
69336-112	Not Applicable	omeprazole sodium bicarbonate	Sterling Knight Pharmaceuticals LLC	ANDA	Current
69367-195	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-195	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-195	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-195	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-195	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-196	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-196	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-196	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-196	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-196	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-984	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Proficient Rx LP	ANDA	Current
71205-985	Omeprazole/Bicarbonate	Omeprazole and Sodium Bicarbonate	Proficient Rx LP	ANDA	Current
71399-2420	omeprazole sodium bicarbonate	omeprazole sodium bicarbonate	Akron Pharma Inc	ANDA	Current
71399-2440	omeprazole sodium bicarbonate	omeprazole sodium bicarbonate	Akron Pharma Inc	ANDA	Current