FDA NDA · NDA206426

RAPIVAB

Sponsor: BIOCRYST

APPLICATION

NDA206426

TYPE

NDA

ORIGINAL APPROVAL

2014-12-19

LATEST ACTION

2024-06-13

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

RAPIVAB · ReferencePrescription

PERAMIVIR 200MG/20ML (10MG/ML) · SOLUTION · INTRAVENOUS

2024-06-13Labeling · Supplement 9 · standard — Letter ↗AP

2021-01-28Efficacy · Supplement 7 · priority — Letter ↗AP

2018-05-03Labeling · Supplement 5 · standard — Label ↗AP

2017-09-20Efficacy · Supplement 4 · priority — Label ↗AP

2016-11-02Manufacturing (CMC) · Supplement 2 · standardAP

2016-08-12Labeling · Supplement 3 · 901 required — Label ↗AP

2016-03-11Manufacturing (CMC) · Supplement 1 · standardAP

2014-12-19Type 1 - New Molecular Entity · Original · standard — Label ↗AP

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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