Application 207967

Type: ANDA
Sponsor: B BRAUN MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	INJECTABLE;INJECTION	2GM/50ML (40MG/ML)	No	No
002	MAGNESIUM SULFATE	MAGNESIUM SULFATE	INJECTABLE;INJECTION	4GM/100ML (40MG/ML)	No	No
003	MAGNESIUM SULFATE	MAGNESIUM SULFATE	INJECTABLE;INJECTION	4GM/50ML (80MG/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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207967-001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26
A207967-002	MAGNESIUM SULFATE	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26
A207967-003	MAGNESIUM SULFATE	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207967-001	AP
A207967-002	AP
A207967-003	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.

Product history page 1 of 3 · 102 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
2026-08-18 06:07:40	2026-07	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207967-002	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207967-003	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207967-001	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-04-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207967-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207967-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207967-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207967-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207967-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207967-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207967-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207967-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207967-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207967-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207967-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207967-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207967-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207967-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207967-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207967-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207967-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207967-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207967-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207967-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207967-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207967-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207967-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207967-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207967-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207967-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207967-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207967-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207967-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207967-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207967-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207967-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207967-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207967-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207967-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207967-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207967-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207967-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207967-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207967-001	AP	1	`1e350fbaab3a…`

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 Water	MAGNESIUM SULFATE HEPTAHYDRATE	B. Braun Medical Inc.	f5f6b4c9-4a68-4342-b1e4-f4b61b7fb9cb	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207967 application number: ANDA207967 ndc (product): 0264-4204 ndc (product): 0264-4205 ndc (product): 0264-4206

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-4204	Magnesium Sulfate in Water	magnesium sulfate heptahydrate	B. Braun Medical Inc.	ANDA	Current
0264-4204	Magnesium Sulfate in Water	magnesium sulfate heptahydrate	B. Braun Medical Inc.	ANDA	Current
0264-4205	Magnesium Sulfate in Water	magnesium sulfate heptahydrate	B. Braun Medical Inc.	ANDA	Current
0264-4205	Magnesium Sulfate in Water	magnesium sulfate heptahydrate	B. Braun Medical Inc.	ANDA	Current
0264-4206	Magnesium Sulfate in Water	magnesium sulfate heptahydrate	B. Braun Medical Inc.	ANDA	Current
0264-4206	Magnesium Sulfate in Water	magnesium sulfate heptahydrate	B. Braun Medical Inc.	ANDA	Current