← FDA DRUG APPROVALS

FDA NDA · NDA206843

DAKLINZA

Sponsor: BRISTOL-MYERS SQUIBB

APPLICATION
NDA206843
TYPE
NDA
ORIGINAL APPROVAL
2015-07-24
LATEST ACTION
2019-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DAKLINZA · ReferenceDiscontinued
DACLATASVIR DIHYDROCHLORIDE EQ 90MG BASE · TABLET · ORAL
DAKLINZA · ReferenceDiscontinued
DACLATASVIR DIHYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
DAKLINZA · ReferenceDiscontinued
DACLATASVIR DIHYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL

Approval history

2019-10-16Labeling · Supplement 8 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 7 · standard — Letter ↗AP
2017-02-14Labeling · Supplement 6 · 901 required — Letter ↗AP
2016-12-21Manufacturing (CMC) · Supplement 5 · standardAP
2016-04-13Manufacturing (CMC) · Supplement 4 · priority — Label ↗AP
2016-02-05Efficacy · Supplement 3 · priority — Label ↗AP
2016-02-05Efficacy · Supplement 1 · priority — Summary Review ↗AP
2016-02-05Efficacy · Supplement 2 · priority — Label ↗AP
2015-07-24Type 1 - New Molecular Entity · Original · priority — 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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