← FDA Drug Approvals (Drugs@FDA)

VARENICLINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS USA · Approved 2013-09-10

Drug application

FDA Application #

ANDA201920

Application type

Abbreviated New Drug Application (Generic)

Brand name

VARENICLINE

Generic name

Varenicline

Active ingredients

VARENICLINE

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

TEVA PHARMS USA

First approval

2013-09-10

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown