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FDA NDA · NDA207865

EMEND

aprepitant

Sponsor: MSD MERCK CO

APPLICATION
NDA207865
TYPE
NDA
ORIGINAL APPROVAL
2015-12-17
LATEST ACTION
2019-11-14
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

EMEND · ReferencePrescription
APREPITANT 125MG/KIT · FOR SUSPENSION · ORAL

Approval history

2019-11-14Labeling · Supplement 3 · standard — Letter ↗AP
2019-09-25Labeling · Supplement 4 · standard — Letter ↗AP
2017-05-31Labeling · Supplement 1 · standard — Label ↗AP
2015-12-17Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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