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FDA NDA · NDA209296

CINVANTI

aprepitant

Sponsor: HERON THERAPS INC

APPLICATION
NDA209296
TYPE
NDA
ORIGINAL APPROVAL
2017-11-09
LATEST ACTION
2024-03-05
ROUTE
INTRAVENOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription

Products

CINVANTI · ReferencePrescription
APREPITANT 130MG/18ML (7.2MG/ML) · EMULSION · INTRAVENOUS

Approval history

2024-03-05Labeling · Supplement 15 · standard — Letter ↗AP
2022-03-14Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2019-10-21Efficacy · Supplement 4 · standard — Letter ↗AP
2019-02-26Efficacy · Supplement 3 · standard — Label ↗AP
2017-11-09Type 3 - New Dosage Form · Original · standard — Letter ↗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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