Application 204922

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

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
A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-08-19
A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204922-001	AB
A204922-002	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	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`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	A204922-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204922-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204922-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204922-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204922-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204922-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204922-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204922-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204922-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204922-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204922-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204922-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204922-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204922-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204922-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204922-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204922-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204922-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204922-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204922-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204922-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204922-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204922-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204922-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204922-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204922-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204922-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204922-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204922-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204922-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204922-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204922-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204922-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204922-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204922-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204922-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204922-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204922-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204922-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204922-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE AND SODIUM BICARBONATE	Aurohealth LLC	88ad2e92-2228-49b2-bcee-1770fd30cb14	2025-12-04	Warnings	Name fallback brand name: OMEPRAZOLE AND SODIUM BICARBONATE
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Ajanta Pharma USA Inc.	bd84ca00-6352-4cb3-bce2-05f4a5005a94	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Walgreen Company	8753a131-f8b1-48e1-993b-73c1ee635fef	2025-11-04	Warnings	Name fallback brand name: Omeprazole and sodium bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	CVS Pharmacy	186732a3-13b9-4ea2-ba54-424f63298a2e	2025-11-04	Warnings	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	H E B	ddc8d73f-f4a1-42a7-89ee-420346820f61	2025-11-03	Warnings	Name fallback brand name: Omeprazole and sodium bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Ajanta Pharma USA Inc.	cb657607-b038-47ee-b4e7-a5f419a14c33	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Meijer Distribution Inc	bb7c1c5d-b915-42f5-a5a2-5f61b088028d	2025-09-05	Warnings	Name fallback brand name: omeprazole and sodium bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	PHOENIX RX LLC	3b2bf501-fd81-6ffa-e063-6394a90afe42	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	PHOENIX RX LLC	3b2cf6fd-72cb-fa53-e063-6394a90a674a	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Bryant Ranch Prepack	0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Oceanside Pharmaceuticals	c26b6893-8264-4d4a-ac7e-1ddda933451e	2025-05-02	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	ScieGen Pharmaceuticals, Inc.	a107804e-b308-4e79-9447-07d93016f70f	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	ddee28fb-c871-a6d4-984f-515522b28412	2024-07-15	Warnings	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	ANI Pharmaceuticals, Inc.	63c3bd6c-a586-4ec0-8f45-ed936936dfeb	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	c6b5f808-4a49-1303-9711-badb022ecd70	2023-07-19	Warnings	Name fallback brand name: Omeprazole and Sodium Bicarbonate

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-115	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Aurolife Pharma, LLC	ANDA	Current
13107-115	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Aurolife Pharma, LLC	ANDA	Current
13107-116	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Aurolife Pharma, LLC	ANDA	Current
13107-116	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Aurolife Pharma, LLC	ANDA	Current
69665-216	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Medarbor Llc	ANDA	Current