FDA.reportPublic FDA data

Application 218728

Type
ANDA
Sponsor
HIKMA PHARMACEUTICALS USA INC

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
A218728-001SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28
A218728-002SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218728-001AP
A218728-002AP

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 06:07:402026-07A218728-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A218728-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218728-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A218728-002AP1caaa826d4ba7…