← FDA Drug Approvals (Drugs@FDA)

VARENICLINE TARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2023-10-23

Drug application

FDA Application #

ANDA214571

Application type

Abbreviated New Drug Application (Generic)

Brand name

VARENICLINE TARTRATE

Generic name

VARENICLINE TARTRATE

Active ingredients

VARENICLINE TARTRATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

HETERO LABS LTD III

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2023-10-23

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown