Application 213917

Type: ANDA
Sponsor: GLAND PHARMA 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 42.

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
A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP		2020-07-10
A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP		2020-07-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213917-001	AP
A213917-002	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 2 · 76 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
2026-08-18 06:07:40	2026-07	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213917-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213917-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2020-07-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213917-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213917-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213917-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213917-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213917-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213917-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213917-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213917-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213917-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213917-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213917-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213917-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213917-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213917-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213917-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213917-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213917-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213917-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213917-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213917-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213917-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213917-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213917-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213917-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213917-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213917-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213917-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213917-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213917-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213917-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213917-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213917-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213917-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213917-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213917-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213917-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213917-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213917-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213917-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213917-002	AP	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAGNESIUM SULFATE	MAGNESIUM SULFATE HEPTAHYDRATE	Sun Pharmaceutical Industries, Inc.	efadcb55-f935-4c60-b2e2-0a76b9194b50	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213917 application number: ANDA213917 ndc (product): 47335-992
Magnesium Sulfate	MAGNESIUM SULFATE HEPTAHYDRATE	Sagent Pharmaceuticals	a607796c-6676-4d0a-8108-8708fe6769ed	2020-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213917 application number: ANDA213917 ndc (product): 25021-612
MAGNESIUM SULFATE	MAGNESIUM SULFATE HEPTAHYDRATE	Gland Pharma Limited	a9e706ac-9c5f-4b14-b277-53dee195ffc6	2020-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213917 application number: ANDA213917 ndc (product): 68083-397 ndc (product): 68083-396

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-612	Magnesium Sulfate	Magnesium Sulfate Heptahydrate	Sagent Pharmaceuticals	ANDA	Current
47335-992	MAGNESIUM SULFATE	magnesium sulfate heptahydrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
68083-396	MAGNESIUM SULFATE	MAGNESIUM SULFATE HEPTAHYDRATE	Gland Pharma Limited	ANDA	Current
68083-397	MAGNESIUM SULFATE	MAGNESIUM SULFATE HEPTAHYDRATE	Gland Pharma Limited	ANDA	Current