← FDA DRUG APPROVALS

FDA NDA · NDA212295

BYFAVO

remimazolam besylate

Sponsor: ACACIA

APPLICATION
NDA212295
TYPE
NDA
ORIGINAL APPROVAL
2020-07-02
LATEST ACTION
2023-01-13
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

BYFAVO · ReferencePrescription
REMIMAZOLAM BESYLATE EQ 20MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2023-01-13Labeling · Supplement 3 · standard — Label ↗AP
2021-04-08Labeling · Supplement 2 · standard — Letter ↗AP
2020-11-30Labeling · Supplement 1 · standard — Letter ↗AP
2020-07-02Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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