FDA.reportPublic FDA data

Application 220274

Type
ANDA
Sponsor
EXTROVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM ACETATESODIUM ACETATESOLUTION;INTRAVENOUS100MEQ/50ML (2MEQ/ML)NoNo
002SODIUM ACETATESODIUM ACETATESOLUTION;INTRAVENOUS200MEQ/100ML (2MEQ/ML)NoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220274-001SODIUM ACETATESODIUM ACETATE100MEQ/50ML (2MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-17
A220274-002SODIUM ACETATESODIUM ACETATE200MEQ/100ML (2MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A220274-001AP
A220274-002AP

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 06:07:402026-07A220274-001SODIUM ACETATE100MEQ/50ML (2MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07A220274-002SODIUM ACETATE200MEQ/100ML (2MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-17caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220274-001SODIUM ACETATE100MEQ/50ML (2MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220274-002SODIUM ACETATE200MEQ/100ML (2MEQ/ML)SOLUTION / INTRAVENOUSAP2026-04-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220274-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220274-002AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220274-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220274-002AP1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium AcetateSODIUM ACETATEAmneal Pharmaceuticals Private Limited0c0b11da-d7fc-4b4c-b0ef-d97af8e88abf2026-08-21Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEHospira, Inc.ce9a7469-c4ba-4f60-8f7a-47ef0974316e2026-03-26Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEHospira, Inc.c91ede49-c7cc-47b7-0f93-e6841dd5916a2026-03-26Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEHospira, Inc.abc41ed1-9512-4bea-9295-1a9ca134b6c22026-03-26Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEHospira, Inc.c3be2468-45e8-4ecc-a30b-e966743a563f2026-03-26Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEMILLA PHARMACEUTICALS INC.1ea1466d-a492-4056-e063-6394a90a80bf2026-01-07Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
SODIUM ACETATESODIUM ACETATEAmneal Pharmaceuticals Private Limited338105c0-c645-4b84-a125-4e1ead92b8402025-08-11Warnings, Adverse reactionsName fallback
brand name: SODIUM ACETATE
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEMILLA PHARMACEUTICALS INC.1ea04916-78e5-4651-e063-6394a90ac4be2025-01-16Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
SODIUM ACETATESODIUM ACETATEFresenius Kabi USA, LLCd7fabf08-d4e0-4bb5-8416-2e8ffe27c04b2024-10-11Warnings, Adverse reactionsName fallback
brand name: SODIUM ACETATE
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEHikma Pharmaceuticals USA Inc.8a338072-6f1e-460c-b9ec-59cef4f3f5972024-05-08Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE
Sodium AcetateSODIUM ACETATEHikma Pharmaceuticals USA Inc.7ee23a1c-bc99-4ff6-b2e7-d2aa427445532024-05-08Warnings, Adverse reactionsName fallback
brand name: Sodium Acetate
generic name: SODIUM ACETATE