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 43.

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 · 86 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	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204922-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204922-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-08-19	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A204922-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204922-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204922-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204922-002	AB	1	`caaa826d4ba7…`
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…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Amazon.com Services LLC	bb453f26-c7df-4cce-8793-337cb5d5f9a9	2026-08-19	Warnings	Name fallback brand name: omeprazole and sodium bicarbonate
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	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

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 · 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