Application 207350

Type: ANDA
Sponsor: HQ SPCLT PHARMA

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	2GM/50ML (40MG/ML)	No	No
002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	4GM/100ML (40MG/ML)	No	No
003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	4GM/50ML (80MG/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 44.

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
A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06
A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06
A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06
A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06
A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207350-001	AP
A207350-002	AP
A207350-003	AP
A207350-004	AP
A207350-005	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 · 220 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
2026-10-15 13:18:30	2026-09	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	2017-12-06	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207350-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-003	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-004	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207350-005	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207350-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207350-005	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207350-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207350-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207350-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207350-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207350-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207350-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207350-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207350-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207350-005	AP	1	`b8a1b40f171c…`

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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	7d94995b-9e2a-0345-e053-2991aa0a62d0	2024-01-28	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Humco Epson Salt	MAGNESIUM SULFATE	Humco Holding Group, Inc.	7a9d1b77-6c39-46f1-86f2-4059dde20f85	2023-12-15	Warnings	Name fallback generic name: MAGNESIUM SULFATE
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	945419b8-6184-f4f3-e053-2a95a90a6236	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	94e9a33f-39c4-4bc5-e053-2a95a90a43ac	2022-12-10	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	9947731b-fb0f-0c68-e053-2a95a90a815e	2022-12-10	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-420	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-420	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-420	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-421	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-421	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-421	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-422	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-422	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-422	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-423	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-423	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-423	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-424	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-424	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current
44567-424	Magnesium Sulfate	Magnesium Sulfate	WG Critical Care, LLC	ANDA	Current