Application 020488

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	1GM/100ML	Yes	Yes
002	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	2GM/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020488-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-07-11
N020488-002	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/100ML	INJECTABLE / INJECTION		RLD, RS	1995-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020488-001	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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020488-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-07-11	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020488-002	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION		RLD, RS	1995-07-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020488-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-07-11	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020488-002	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION		RLD, RS	1995-07-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020488-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-07-11	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020488-002	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION		RLD, RS	1995-07-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020488-001	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-07-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020488-002	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION		RLD, RS	1995-07-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020488-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020488-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020488-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020488-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020488-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020488-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020488-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020488-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020488-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020488-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020488-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020488-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020488-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020488-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020488-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020488-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020488-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020488-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020488-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020488-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020488-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020488-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020488-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020488-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020488-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020488-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020488-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020488-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020488-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020488-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020488-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020488-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020488-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020488-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020488-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020488-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020488-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020488-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020488-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020488-001	AP	1	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Magnesium Sulfate in Dextrose	MAGNESIUM SULFATE IN DEXTROSE	Hospira, Inc.	03ebeabb-8386-4af4-3086-bdf3c3fc4a5a	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020488 application number: NDA020488 ndc (product): 0409-6727

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-6727	Magnesium Sulfate in Dextrose	Magnesium Sulfate in Dextrose	Hospira, Inc.	NDA	Current
0409-6727	Magnesium Sulfate in Dextrose	Magnesium Sulfate in Dextrose	Hospira, Inc.	NDA	Current
0409-6727	Magnesium Sulfate in Dextrose	Magnesium Sulfate in Dextrose	Hospira, Inc.	NDA	Current
0409-6727	Magnesium Sulfate in Dextrose	Magnesium Sulfate in Dextrose	Hospira, Inc.	NDA	Current
0409-6727	Magnesium Sulfate in Dextrose	Magnesium Sulfate in Dextrose	Hospira, Inc.	NDA	Current
0409-6727	Magnesium Sulfate in Dextrose	Magnesium Sulfate in Dextrose	Hospira, Inc.	NDA	Current
0409-6727	Magnesium Sulfate in Dextrose	Magnesium Sulfate in Dextrose	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58350	SUPPL	2019-04-18
58343	SUPPL	2019-04-18
25036	SUPPL	2013-06-05
34703	SUPPL	2013-06-04
41393	ORIG	1995-07-01