FDA.reportPublic FDA data

Application 219777

Type
ANDA
Sponsor
ASPIRO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS1GM/2ML (500MG/ML)NoNo
002MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS5GM/10ML (500MG/ML)NoNo
003MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS10GM/20ML (500MG/ML)NoNo
004MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS25GM/50ML (500MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219777-001MAGNESIUM SULFATEMAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28
A219777-002MAGNESIUM SULFATEMAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28
A219777-003MAGNESIUM SULFATEMAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28
A219777-004MAGNESIUM SULFATEMAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A219777-001AP
A219777-002AP
A219777-003AP
A219777-004AP

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A219777-001CGT2026-02-01
A219777-004CGT2026-02-01

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-001MAGNESIUM SULFATE1GM/2ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-002MAGNESIUM SULFATE5GM/10ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-003MAGNESIUM SULFATE10GM/20ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-004MAGNESIUM SULFATE25GM/50ML (500MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2025-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219777-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219777-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219777-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219777-004AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-003AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-004AP1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A219777-001CGT2026-02-01caaa826d4ba7…
2026-08-18 06:07:402026-07A219777-004CGT2026-02-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219777-001CGT2026-02-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219777-004CGT2026-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-001CGT2026-02-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219777-004CGT2026-02-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-001CGT2026-02-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219777-004CGT2026-02-01a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATECamber Pharmaceuticals, Inc.647ca293-9e68-4773-947a-0fb064aa6fd12025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219777
application number: ANDA219777