Application 020309

Type: NDA
Sponsor: HOSPIRA

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	4GM/100ML (40MG/ML)	Yes	Yes
002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	4GM/50ML (80MG/ML)	Yes	Yes
003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	2GM/50ML (40MG/ML)	Yes	No
004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	20GM/500ML (40MG/ML)	Yes	No
005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	INJECTABLE;INJECTION	40GM/1000ML (40MG/ML)	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24
N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24
N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26
N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18
N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N020309-001	AP
N020309-002	AP
N020309-003	AP
N020309-004	AP
N020309-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020309-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020309-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1994-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020309-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	2007-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020309-004	MAGNESIUM SULFATE IN PLASTIC CONTAINER	20GM/500ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020309-005	MAGNESIUM SULFATE IN PLASTIC CONTAINER	40GM/1000ML (40MG/ML)	INJECTABLE / INJECTION	AP	RLD	1995-01-18	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	N020309-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020309-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020309-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020309-004	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020309-005	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020309-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020309-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020309-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020309-004	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020309-005	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020309-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020309-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020309-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020309-004	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020309-005	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020309-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020309-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020309-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020309-004	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020309-005	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020309-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020309-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020309-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020309-004	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020309-005	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020309-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020309-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020309-003	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020309-004	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020309-005	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020309-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020309-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020309-003	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020309-004	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020309-005	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020309-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020309-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020309-003	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020309-004	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020309-005	AP	1	`ea1830bbd6c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	22ca78b4-f5a3-4144-cf89-5f633acf1e6d	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020309 application number: NDA020309 ndc (product): 0409-4121 ndc (product): 0409-6729 ndc (product): 0409-2050 ndc (product): 0409-5239
MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	7d94995b-9e2a-0345-e053-2991aa0a62d0	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020309 application number: NDA020309 ndc (product): 51662-1352

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-2050	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-2050	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-4121	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-5239	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6729	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6729	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6729	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6729	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6729	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6729	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6730	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6730	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6730	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6730	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6730	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
0409-6730	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Hospira, Inc.	NDA	Current
50090-2376	Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	A-S Medication Solutions	NDA	Current
51662-1352	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1352	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1352	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1352	MAGNESIUM SULFATE	MAGNESIUM SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72130	SUPPL	2022-09-21
72100	SUPPL	2022-09-19
34495	SUPPL	2013-06-04
24760	SUPPL	2013-05-30
41277	ORIG	2011-02-15
24759	SUPPL	2007-02-12