DAKLINZA

Product NDC

0003-0011

11-digit product format

000030011

Labeler code

0003

Product ID

0003-0011_780ae42b-9b05-4a02-9529-5e45dbb460f6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

daclatasvir

Dosage form

TABLET

Route

ORAL

Labeler

E.R. Squibb & Sons, L.L.C.

Application

NDA206843

Marketing category

NDA

Marketing start

2016-05-18

Marketing end

2019-04-30

Substance

DACLATASVIR DIHYDROCHLORIDE

Active strength

90 mg/1

Pharmacologic classes

Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record