Application 217594

Type: ANDA
Sponsor: STERISCIENCE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM BICARBONATE	SODIUM BICARBONATE	SOLUTION;INTRAVENOUS	50MEQ/50ML (1MEQ/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A217594-001	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP		2023-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217594-001	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217594-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217594-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217594-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION		2023-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION		2023-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217594-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217594-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217594-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217594-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217594-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217594-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217594-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217594-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217594-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217594-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217594-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217594-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217594-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217594-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217594-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217594-001	AP	1	`8072bd15b7f6…`
2023-12-20 04:57 UTC	2023-12	A217594-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217594-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217594-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217594-001	AP	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217594-001	AP	1	`a50c72e98297…`

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
SODIUM BICARBONATE	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	4f97d398-2118-0874-e063-6394a90a4ad1	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594
SODIUM BICARBONATE	SODIUM BICARBONATE	ProPharma Distribution	3867f743-c2cf-a646-e063-6394a90a82e1	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594
SODIUM BICARBONATE	SODIUM BICARBONATE	Sun Pharmaceutical Industries Limited	5ae65432-04a1-4b6b-8536-2535064fc782	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594
Sodium Bicarbonate	SODIUM BICARBONATE	Steriscience Specialties Private Limited	eb2996b4-c04c-4678-b8a9-5cbbe509bb70	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594