Application 206485

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	4GM/100ML (40MG/ML)	No	No
002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	4GM/50ML (80MG/ML)	No	No
003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	2GM/50ML (40MG/ML)	No	No
004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	20GM/500ML (40MG/ML)	No	No
005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	40GM/1000ML (40MG/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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15
A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A206485-001	AP
A206485-002	AP
A206485-003	AP
A206485-004	AP
A206485-005	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 6 · 210 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	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2016-03-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A206485-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206485-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206485-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206485-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206485-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206485-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206485-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206485-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206485-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206485-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206485-005	AP	1	`2680178bc6a6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	fef9e18c-5210-4090-b564-4950ebe461c0	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206485 application number: ANDA206485 ndc (product): 63323-107 ndc (product): 63323-106
magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	43d658b1-2b19-44be-a346-cac11fd600b3	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206485 application number: ANDA206485 ndc (product): 63323-106
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	9947731b-fb0f-0c68-e053-2a95a90a815e	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206485 application number: ANDA206485 ndc (product): 51662-1373

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3323	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	A-S Medication Solutions	ANDA	Current
51662-1373	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1373	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1373	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-106	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-106	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-106	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-106	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-106	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-106	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-106	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-107	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-107	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-107	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-107	magnesium sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	ANDA	Current
66298-1060	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi Norge AS	ANDA	Current
66298-1070	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi Norge AS	ANDA	Current