← FDA DRUG APPROVALS

FDA NDA · NDA203093

VITEKTA

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA203093
TYPE
NDA
ORIGINAL APPROVAL
2014-09-24
LATEST ACTION
2016-01-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VITEKTA · ReferenceDiscontinued
ELVITEGRAVIR 150MG · TABLET · ORAL
VITEKTA · ReferenceDiscontinued
ELVITEGRAVIR 85MG · TABLET · ORAL

Approval history

2016-01-21Manufacturing (CMC) · Supplement 3 · standardAP
2015-07-27Labeling · Supplement 2 · standard — Label ↗AP
2015-07-16Manufacturing (CMC) · Supplement 1 · standardAP
2014-09-24Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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