Application 019316

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	5GM/10ML (500MG/ML)	Yes	Yes
002	MAGNESIUM SULFATE	MAGNESIUM SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	1GM/2ML (500MG/ML)	Yes	Yes
003	MAGNESIUM SULFATE	MAGNESIUM SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	10GM/20ML (500MG/ML)	Yes	Yes
004	MAGNESIUM SULFATE	MAGNESIUM SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	25GM/50ML (500MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019316-001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08
N019316-002	MAGNESIUM SULFATE	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08
N019316-003	MAGNESIUM SULFATE	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29
N019316-004	MAGNESIUM SULFATE	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N019316-001	AP
N019316-002	AP
N019316-003	AP
N019316-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019316-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	1986-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-002	MAGNESIUM SULFATE	1GM/2ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	1986-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-003	MAGNESIUM SULFATE	10GM/20ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2016-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-004	MAGNESIUM SULFATE	25GM/50ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2016-01-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019316-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019316-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019316-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019316-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019316-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019316-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019316-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019316-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019316-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019316-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019316-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019316-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019316-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019316-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019316-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019316-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019316-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019316-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019316-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019316-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019316-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019316-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019316-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019316-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019316-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019316-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019316-003	AP	1	`4b0b4de00fa7…`

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 · 13 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	e921a46b-9a5b-4163-9c88-224247541f14	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 63323-064
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	e9c10579-29f3-4889-8881-0626f63968d4	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 63323-064
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	6a5d362b-7aa7-40d3-898d-09407cce0713	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 63323-064
Magnesium Sulfate	MAGNESIUM SULFATE	Henry Schein, Inc.	c255b8a9-68da-49c1-897b-bc18b731e459	2025-10-31	Warnings	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 0404-9902
Magnesium Sulfate	MAGNESIUM SULFATE	Henry Schein, Inc.	5176ed24-015e-43fe-9eb4-85098debf5f1	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	ProPharma Distribution	3f003556-d675-1cf9-e063-6294a90a2cc4	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	REMEDYREPACK INC.	8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	ProPharma Distribution	386d55c9-aeac-5597-e063-6294a90a0afe	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	7978a5b6-0d9c-499e-e053-2a91aa0a06ad	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 71872-7142
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	945419b8-6184-f4f3-e053-2a95a90a6236	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 51662-1390
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	94e9a33f-39c4-4bc5-e053-2a95a90a43ac	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 51662-1372
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	77f70e00-3934-4fd9-a581-4cf3df8c42d2	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 63323-642
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	b6352fbd-d3ee-2d3a-e053-2a95a90a747d	2020-12-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019316 application number: NDA019316 ndc (product): 71872-7229

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9902	Magnesium Sulfate	Magnesium Sulfate	Henry Schein, Inc.	NDA	Current
0404-9902	Magnesium Sulfate	Magnesium Sulfate	Henry Schein, Inc.	NDA	Current
0404-9902	Magnesium Sulfate	Magnesium Sulfate	Henry Schein, Inc.	NDA	Current
51662-1372	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1372	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1372	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1390	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1390	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1451	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1451	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1451	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-064	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
52584-064	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
52584-064	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
52584-642	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
52584-642	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
52584-642	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
52584-642	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
52584-642	Magnesium Sulfate	Magnesium Sulfate	General Injectables and Vaccines, Inc.	NDA	Current
55154-9358	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Cardinal Health	NDA	Current
63323-064	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	Fresenius Kabi USA, LLC	NDA	Current
63323-064	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-064	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-064	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-064	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-064	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	Fresenius Kabi USA, LLC	NDA	Current
63323-064	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-642	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-642	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-642	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	NDA	Current
70518-0950	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	REMEDYREPACK INC.	NDA	Current
71872-7055	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7055	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7142	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7142	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7229	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52914	SUPPL	2018-03-12
52825	SUPPL	2018-03-06
11475	SUPPL	2013-06-04
1283	SUPPL	2013-05-30
17358	SUPPL	2006-12-28
33723	SUPPL	2006-12-14