Application 207350

Type
ANDA
Sponsor
HQ SPCLT PHARMA

Application Products#

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

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

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
A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06
A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207350-001AP
A207350-002AP
A207350-003AP
A207350-004AP
A207350-005AP

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 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06c2088c7a36db…
2026-10-15 13:18:302026-09A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06c2088c7a36db…
2026-10-15 13:18:302026-09A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06c2088c7a36db…
2026-10-15 13:18:302026-09A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06c2088c7a36db…
2026-10-15 13:18:302026-09A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06c2088c7a36db…
2026-09-14 22:38:342026-08A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0684e616aacf4f…
2026-08-18 06:07:402026-07A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-001MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-002MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-003MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-004MAGNESIUM SULFATE IN PLASTIC CONTAINER20GM/500ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-005MAGNESIUM SULFATE IN PLASTIC CONTAINER40GM/1000ML (40MG/ML)INJECTABLE / INJECTIONAP2017-12-06b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A207350-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09A207350-002AP1c2088c7a36db…
2026-10-15 13:18:302026-09A207350-003AP1c2088c7a36db…
2026-10-15 13:18:302026-09A207350-004AP1c2088c7a36db…
2026-10-15 13:18:302026-09A207350-005AP1c2088c7a36db…
2026-09-14 22:38:342026-08A207350-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A207350-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A207350-003AP184e616aacf4f…
2026-09-14 22:38:342026-08A207350-004AP184e616aacf4f…
2026-09-14 22:38:342026-08A207350-005AP184e616aacf4f…
2026-08-18 06:07:402026-07A207350-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207350-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207350-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207350-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207350-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207350-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207350-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207350-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207350-005AP1b8a1b40f171c…

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATECardinal Health, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATESafeway Inc0b757160-f9eb-4413-9b43-97544c49c72f2026-08-10Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEVi-Jon, LLCba490c22-19f0-4887-9509-bd3d32e0f5b12026-06-24Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATECVS PHARMACY, INC1f9e72dc-a394-420d-8fe8-fc4d0f6906ed2026-05-27WarningsName fallback
generic name: MAGNESIUM SULFATE
Magnesium SulfateMAGNESIUM SULFATEHospira, Inc.d4b5863a-efb9-4551-a9ad-2b06e8666d872026-04-23Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEAmazon.com Services LLC787ec4b0-c6c5-44ab-a53d-d6d25304f95e2026-03-03Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEOld East Main Co.a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f52026-03-02Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEChain Drug Marketing Association4ee26633-8eb1-4c68-a768-20460404533a2026-02-27Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.3b8eae67-9e27-46bd-ab2b-02c719786bab2026-02-19Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.2070a4a6-7968-49f2-84ec-53bd1cd824452026-02-19Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEValu Merchandisers Companyff539c1c-9ed3-49be-9b30-1858f12e1e902026-02-16Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATETopco Associates LLCb2ec06b3-647d-49ab-a392-6db63d96d1e32026-02-13Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATETopco Associates LLC72f69aa0-381a-4e5c-975d-3a73fdc1b3772026-02-13Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Magnesium SulfateMAGNESIUM SULFATEHospira, Inc.e175d329-315f-4f3b-bb4c-06ad4e0429672026-02-12Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
365 Whole Foods Market Epsom SaltMAGNESIUM SULFATEWhole Foods Market, Inc.4147cdd0-57f6-3857-e063-6394a90afecb2026-02-12Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEYour Military Exchanges27cff497-123c-424a-9c43-57740c00168b2026-02-12Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEWalgreen Co.b5a02809-6e01-4e01-b1c3-2b10c5091a4e2026-02-12Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATERetail Business Services, LLC1a8b540c-b66e-4dca-b7af-23705ae247b62026-02-06Warnings, Adverse reactionsName fallback
generic name: MAGNESIUM SULFATE
Epsom SaltMAGNESIUM SULFATEPublix Super Markets, Inc.e985e071-5541-456e-ae4d-dba85287fe752026-02-05Warnings, Adverse reactionsName 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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-420Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-420Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-420Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-421Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-421Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-421Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-422Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-422Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-422Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-423Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-423Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-423Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-424Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-424Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-424Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent