FDA.reportPublic FDA data

Application 215701

Type
ANDA
Sponsor
SHANDONG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUGAMMADEX SODIUMSUGAMMADEX SODIUMINJECTABLE;INJECTION200MG/2ML(100MG/ML)NoNo
002SUGAMMADEX SODIUMSUGAMMADEX SODIUMINJECTABLE;INJECTION500MG/5ML(100MG/ML)NoNo

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

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
A215701-001SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06
A215701-002SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215701-001AP
A215701-002AP

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
2026-10-15 13:18:302026-09A215701-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06c2088c7a36db…
2026-10-15 13:18:302026-09A215701-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06c2088c7a36db…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A215701-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09A215701-002AP1c2088c7a36db…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sugammadexSUGAMMADEX SODIUMSolupharm Pharmazeutische Erzeugnisse GmbHf92c4e53-13d1-46f2-acf8-6730c3cfac692026-08-20Warnings, Adverse reactionsName fallback
generic name: SUGAMMADEX SODIUM
SUGAMMADEX SODIUMSUGAMMADEX SODIUMPar Health USA, LLC579a2a1f-4d0c-4851-e063-6294a90a2be62026-07-28Warnings, Adverse reactionsName fallback
brand name: SUGAMMADEX SODIUM
generic name: SUGAMMADEX SODIUM
SUGAMMADEX SODIUMSUGAMMADEX SODIUMSTERISCIENCE SPECIALTIES PRIVATE LIMITED0379799d-b678-4eb1-8f15-7dd183ee2a6e2026-07-28Warnings, Adverse reactionsName fallback
brand name: SUGAMMADEX SODIUM
generic name: SUGAMMADEX SODIUM
SugammadexSUGAMMADEX SODIUMSagent Pharmaceuticals5b25f16e-726a-4464-88da-b188c2f4e0382026-06-16Warnings, Adverse reactionsName fallback
generic name: SUGAMMADEX SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.