Application 211965

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	1GM/100ML	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
A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE / INJECTION	AP		2020-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211965-001	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	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION		2020-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION		2020-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211965-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	2020-08-11	`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	A211965-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211965-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211965-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211965-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211965-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211965-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211965-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211965-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211965-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211965-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211965-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211965-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211965-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211965-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211965-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211965-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211965-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211965-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211965-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211965-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211965-001	AP	1	`87673890dc5c…`
2020-11-12 02:37 UTC	2020-11	A211965-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211965-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211965-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211965-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211965-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211965-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211965-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211965-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211965-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211965-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211965-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211965-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211965-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211965-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211965-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAGNESIUM SULFATE IN DEXTROSE	MAGNESIUM SULFATE IN DEXTROSE	Baxter Healthcare Corporation	1bbaebd0-3f4c-467d-96fd-69cfad5a3fd3	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211965 application number: ANDA211965 ndc (product): 0338-1709

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current
0338-1709	MAGNESIUM SULFATE IN DEXTROSE	magnesium sulfate in dextrose	Baxter Healthcare Corporation	ANDA	Current