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 3 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	Whole Foods Market	5a88048e-5417-4d8e-a149-f51610a5d420	2025-02-19	Warnings	Name fallback generic 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
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	f7309f4a-f1f5-420e-bfc7-fb4495a5afba	2024-10-24	Warnings	Name fallback generic name: MAGNESIUM SULFATE
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	2540ae39-2218-0f6a-e063-6294a90a5efc	2024-10-24	Warnings	Name fallback generic name: MAGNESIUM SULFATE
NATURAL Epsom Salt	MAGNESIUM SULFATE	Universal Distribution Center LLC	b2682e51-ffa4-4556-b2a6-b0dbd543fd4f	2024-10-16	Warnings	Name fallback generic name: MAGNESIUM SULFATE
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
Theraworx Relief for Foot Cramps Roll On	MAGNESIUM SULFATE	AVADIM HOLDINGS, INC.	21b58f2e-f4e0-4506-9e72-54a58d3f3617	2024-01-23	Warnings	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 · 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