Application 204228

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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
A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15
A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204228-001	AB
A204228-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`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	A204228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204228-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204228-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204228-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204228-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204228-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204228-002	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 and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Ajanta Pharma USA Inc.	cb657607-b038-47ee-b4e7-a5f419a14c33	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228 ndc (product): 27241-032 ndc (product): 27241-031
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	PHOENIX RX LLC	3b2bf501-fd81-6ffa-e063-6394a90afe42	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	PHOENIX RX LLC	3b2cf6fd-72cb-fa53-e063-6394a90a674a	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228
Omeprazole/Sodiium Bicarbonate	OMEPRAZOLE/SODIIUM BICARBONATE	Direct_rx	1f7f63c1-17c2-9a05-e063-6394a90abc6f	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-508	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Northstar Rx LLC	ANDA	Current
16714-508	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Northstar Rx LLC	ANDA	Current
16714-508	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Northstar Rx LLC	ANDA	Current
16714-509	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Northstar Rx LLC	ANDA	Current
16714-509	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Northstar Rx LLC	ANDA	Current
16714-509	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Northstar Rx LLC	ANDA	Current
27241-031	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current
27241-031	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma USA Inc.	ANDA	Current
27241-031	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current
27241-031	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current
27241-031	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma USA Inc.	ANDA	Current
27241-031	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current
27241-032	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current
27241-032	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma USA Inc.	ANDA	Current
27241-032	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current
27241-032	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current
27241-032	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma USA Inc.	ANDA	Current
27241-032	Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Ajanta Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10309	ORIG	2016-07-19