Application 020309

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION4GM/100ML (40MG/ML)YesYes
002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION4GM/50ML (80MG/ML)YesYes
003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION2GM/50ML (40MG/ML)YesNo
004MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION20GM/500ML (40MG/ML)YesNo
005MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION40GM/1000ML (40MG/ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24
N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24
N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-26
N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18
N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020309-001AP
N020309-002AP
N020309-003AP
N020309-004AP
N020309-005AP

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-001MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAPRLD, RS1994-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-003MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAPRLD2007-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAPRLD1995-01-185bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020309-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020309-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020309-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020309-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020309-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020309-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020309-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020309-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020309-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020309-005AP15bbf6a4d5a75…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.22ca78b4-f5a3-4144-cf89-5f633acf1e6d2026-04-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 020309
application number: NDA020309
ndc (product): 0409-6730
ndc (product): 0409-4121
ndc (product): 0409-6729
ndc (product): 0409-2050
ndc (product): 0409-5239
MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirst7d94995b-9e2a-0345-e053-2991aa0a62d02024-01-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 020309
application number: NDA020309
ndc (product): 51662-1352

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2050Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-2050Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-4121Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-5239Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
50090-2376Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERA-S Medication SolutionsNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72130SUPPL2022-09-21
72100SUPPL2022-09-19
34495SUPPL2013-06-04
24760SUPPL2013-05-30
41277ORIG2011-02-15
24759SUPPL2007-02-12