Application 209911

Type: ANDA
Sponsor: MYLAN LABS LTD

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION			2018-09-14
A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION			2018-09-14

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 3 · 86 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	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION		2018-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION		2018-09-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION		2018-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION		2018-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION		2018-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION		2018-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209911-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209911-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2018-09-14	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A209911-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209911-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209911-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209911-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209911-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209911-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209911-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209911-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209911-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209911-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209911-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209911-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209911-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209911-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209911-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209911-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209911-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209911-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209911-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209911-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209911-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209911-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209911-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209911-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209911-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209911-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209911-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209911-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209911-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209911-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209911-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209911-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209911-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209911-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209911-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209911-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209911-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209911-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209911-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209911-002	AP	1	`87673890dc5c…`

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
ROYAL Epsom Salt	MAGNESIUM SULFATE	Filo America	40eb04d2-fcc9-4ee2-8483-99699ea7e386	2026-01-22	Warnings	Name fallback generic 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	Henry Schein, Inc.	c255b8a9-68da-49c1-897b-bc18b731e459	2025-10-31	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Magnesium Sulfate	MAGNESIUM SULFATE	Henry Schein, Inc.	5176ed24-015e-43fe-9eb4-85098debf5f1	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Family Dollar (FAMILY WELLNESS)	7de802aa-6c31-451c-995c-8549b2545c69	2025-10-06	Warnings	Name fallback generic 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
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

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-553	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Mylan Institutional LLC	ANDA	Current
67457-553	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Mylan Institutional LLC	ANDA	Current
67457-553	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Mylan Institutional LLC	ANDA	Current
67457-554	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Mylan Institutional LLC	ANDA	Current
67457-554	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Mylan Institutional LLC	ANDA	Current
67457-554	Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Mylan Institutional LLC	ANDA	Current