← FDA DRUG APPROVALS

FDA NDA · NDA214461

TEMBEXA

brincidofovir

Sponsor: EMERGENT BIODEFENSE

APPLICATION
NDA214461
TYPE
NDA
ORIGINAL APPROVAL
2021-06-04
LATEST ACTION
2021-08-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TEMBEXA · ReferencePrescription
BRINCIDOFOVIR 100MG · TABLET · ORAL

Approval history

2021-08-03Labeling · Supplement 1 · standard — Letter ↗AP
2021-06-04Type 2 - New Active Ingredient · Original · priority — Letter ↗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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