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VARENICLINE TARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NE RX PHARMA · Approved 2024-03-06

Drug application

FDA Application #
ANDA217283
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
NE RX PHARMA
Manufacturer
Marlex Pharmaceuticals, Inc.
First approval
2024-03-06

Source

Authoritative
Drugs@FDA application overview
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