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 3 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	Family Dollar (FAMILY WELLNESS)	7de802aa-6c31-451c-995c-8549b2545c69	2025-10-06	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	ProPharma Distribution	3f003556-d675-1cf9-e063-6294a90a2cc4	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Epsom Salt	MAGNESIUM SULFATE	Walgreens	7365e199-5038-48eb-b0b9-7b46f9894dd7	2025-09-05	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	TOP CARE (Topco Associates LLC)	b1222ba6-390d-478d-905b-994fff4d6d58	2025-07-09	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Chain Drug Consortium, LLC	c9807e6e-9dcc-41a2-8956-b61623ac2176	2025-06-27	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	ProPharma Distribution	386d55c9-aeac-5597-e063-6294a90a0afe	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Camber Pharmaceuticals, Inc.	647ca293-9e68-4773-947a-0fb064aa6fd1	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Epsom Salt	MAGNESIUM SULFATE	Safeway, Inc.	947ae6fe-05d9-4bcf-be73-b3e1a2c60227	2025-04-16	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Strategic Sourcing Services LLC	99aa30ed-9659-4f60-a31d-6aaf09909b51	2025-04-14	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	CVS PHARMACY	30ce5cbd-cc7a-0b2d-e063-6394a90a8520	2025-03-20	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	WinCo Foods, LLC	80e420c5-7e1f-4c62-b914-f607767fd239	2025-02-19	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Whole Foods Market	709ad74e-d95d-409d-bd7a-185411fc4bac	2025-02-19	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Whole Foods Market	5a88048e-5417-4d8e-a149-f51610a5d420	2025-02-19	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Magnesium Sulfate	MAGNESIUM SULFATE IN WATER FOR	Amneal Pharmaceuticals LLC	29241655-49c9-4bc4-89f2-79a0b24b562e	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: Magnesium Sulfate
Epsom Salt	MAGNESIUM SULFATE	Harris Teeter, LLC	f55da148-81a3-49cc-bbde-6aef920b8903	2025-02-07	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Cardinal Health (Leader) 70000	cde87f95-73c0-46f5-9349-37e04096048c	2025-01-22	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salts	MAGNESIUM SULFATE	NEW PRIDE CORP	f6626023-4857-518b-e053-2a95a90a9821	2024-12-19	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e4d9bc32-ac85-349f-e053-2995a90a032f	2024-12-19	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e5f3edc2-1b79-533a-e053-2a95a90ae9b6	2024-12-19	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salts	MAGNESIUM SULFATE	Jell Pharmaceuticals Pvt. Ltd.	8d4443ec-fc8b-0119-e053-2a95a90a68f0	2024-12-17	Warnings	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 · 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