Varubi

Product NDC

69656-102

11-digit product format

696560102

Labeler code

69656

Product ID

69656-102_4e6fc087-797c-49a6-905a-dcf658d60aa5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

rolapitant

Dosage form

INJECTION, EMULSION

Route

INTRAVENOUS

Labeler

Tesaro, Inc.

Application

NDA208399

Marketing category

NDA

Marketing start

2017-10-25

Marketing end

0000-00-00

Substance

ROLAPITANT

Active strength

2 mg/mL

Pharmacologic classes

Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record