FDA.reportPublic FDA data

Application 213476

Type
ANDA
Sponsor
KNACK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION50MG/5ML (10MG/ML)NoNo
002ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION100MG/10ML (10MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213476-001ROCURONIUM BROMIDEROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTION2026-01-06
A213476-002ROCURONIUM BROMIDEROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTION2026-01-06

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
2026-09-14 22:38:342026-08A213476-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTION2026-01-0684e616aacf4f…
2026-09-14 22:38:342026-08A213476-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTION2026-01-0684e616aacf4f…
2026-08-18 06:07:402026-07A213476-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTION2026-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A213476-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTION2026-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213476-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2026-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213476-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2026-01-06011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213476-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTION2026-01-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213476-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTION2026-01-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213476-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213476-002AP1011fe1cb6892…

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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
rocuronium bromideROCURONIUM BROMIDEXGen Pharmaceuticals DJB, Inc.b73f192c-2912-4ec3-9b4f-05a58d9b35ba2022-12-02Warnings, Adverse reactionsName fallback
brand name: rocuronium bromide
generic name: ROCURONIUM BROMIDE
Rocuronium BromideROCURONIUM BROMIDESandoz Inccb28d869-6510-4402-9462-f6bb25fa0fa82022-10-13Warnings, Adverse reactionsName fallback
brand name: Rocuronium Bromide
generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirstdc444a4b-16ea-568d-e053-2995a90a53a72022-04-09Warnings, Adverse reactionsName fallback
brand name: ROCURONIUM BROMIDE
generic name: ROCURONIUM BROMIDE
RocuroniumROCURONIUM BROMIDEFresenius Kabi USA, LLC209a654d-f92d-4242-bfef-2dcc90a30d3f2022-01-18Warnings, Adverse reactionsName fallback
generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirst818f7cc6-2c3f-1788-e053-2991aa0a4c6a2021-03-01Warnings, Adverse reactionsName fallback
brand name: ROCURONIUM BROMIDE
generic name: ROCURONIUM BROMIDE
Rocuronium BromideROCURONIUM BROMIDEBaxter Healthcare Corporation31e15c3f-aefa-4379-b684-7707744fe40d2019-09-30Warnings, Adverse reactionsName fallback
brand name: Rocuronium Bromide
generic name: ROCURONIUM BROMIDE

Reported adverse events (FAERS/openFDA)#

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