Application 206039

Type: ANDA
Sponsor: EXELA PHARMA SCS LLC

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)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206039-001	MAGNESIUM SULFATE	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS			2014-12-18

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 2 · 43 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
2026-09-14 22:38:34	2026-08	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2014-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206039-001	MAGNESIUM SULFATE	5GM/10ML (500MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	2014-12-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206039-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206039-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206039-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206039-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206039-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206039-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206039-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206039-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206039-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206039-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206039-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206039-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206039-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206039-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206039-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206039-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206039-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206039-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206039-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206039-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206039-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206039-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206039-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206039-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206039-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206039-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206039-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206039-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206039-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206039-001	AP	1	`cb3db0bc1861…`

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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsom Salt	MAGNESIUM SULFATE	Walgreen Co.	b5a02809-6e01-4e01-b1c3-2b10c5091a4e	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Retail Business Services, LLC	1a8b540c-b66e-4dca-b7af-23705ae247b6	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Publix Super Markets, Inc.	e985e071-5541-456e-ae4d-dba85287fe75	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Discount Drug Mart	b05a94d2-5cc6-4989-9fb8-096e54fa7852	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Grocery Outlet, Inc.	3dff4b00-e71a-1dc0-e063-6394a90a715f	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	HARRIS TEETER	73065a04-b7cd-437d-9624-f845f5ec93bf	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Hy-Vee, Inc.	44592ee0-13dd-57b1-e063-6394a90ab402	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	CVS Pharmacy, Inc.	a78d991a-ba21-4bc4-b8f9-f8dafbddc28f	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Sam's West, Inc	6edb7688-0a64-4a7e-a0c0-9f75c96682fe	2026-02-03	Warnings	Name fallback generic name: MAGNESIUM SULFATE
MAGNESIUM SULFATE	MAGNESIUM SULFATE HEPTAHYDRATE	Sun Pharmaceutical Industries, Inc.	efadcb55-f935-4c60-b2e2-0a76b9194b50	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: MAGNESIUM SULFATE
ROYAL Epsom Salt	MAGNESIUM SULFATE	Filo America	40eb04d2-fcc9-4ee2-8483-99699ea7e386	2026-01-22	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	e921a46b-9a5b-4163-9c88-224247541f14	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Magnesium Sulfate in Dextrose	MAGNESIUM SULFATE	WG Critical Care, LLC	8da9c33f-e3cd-4026-b034-2b964401b346	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	e9c10579-29f3-4889-8881-0626f63968d4	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Baxter Healthcare Corporation	ea05b8f9-6e11-45c3-824a-4a78818019df	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Fresenius Kabi USA, LLC	6a5d362b-7aa7-40d3-898d-09407cce0713	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Magnesium Sulfate	MAGNESIUM SULFATE	Henry Schein, Inc.	c255b8a9-68da-49c1-897b-bc18b731e459	2025-10-31	Warnings	Name fallback brand name: Magnesium Sulfate generic name: MAGNESIUM SULFATE
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Henry Schein, Inc.	27a581a3-2342-4cc3-b90f-6c739bdf7120	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Civica, Inc.	a5a9f565-639c-4b22-b9e5-718bac7cfcf3	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Magnesium Sulfate	MAGNESIUM SULFATE	Henry Schein, Inc.	5176ed24-015e-43fe-9eb4-85098debf5f1	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-1000	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Exela Pharma Sciences, LLC	ANDA	Current
70518-1607	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	REMEDYREPACK INC.	ANDA	Current