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VARENICLINE TARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2024-03-19

Drug application

FDA Application #

ANDA213019

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

AJANTA PHARMA LTD

Manufacturer

Ajanta Pharma USA Inc.

First approval

2024-03-19

Source

Authoritative

Drugs@FDA application overview

Machine

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