Application 217287

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CUPRIC CHLORIDECUPRIC CHLORIDEINJECTABLE;INJECTIONEQ 0.4MG COPPER/MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217287-001CUPRIC CHLORIDECUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTION2026-01-26

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 06:07:402026-07A217287-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTION2026-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217287-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2026-01-26011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217287-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTION2026-01-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217287-001AP1011fe1cb6892…

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
CUPRIC CHLORIDECUPRIC CHLORIDEAmneal Pharmaceuticals Private Limitedc431cc76-f9ba-43c7-8d66-e93c77fa62292026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217287
application number: ANDA217287