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DABIGATRAN ETEXILATE MESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN · Approved 2024-05-22

Drug application

FDA Application #

ANDA213879

Application type

Abbreviated New Drug Application (Generic)

Brand name

DABIGATRAN ETEXILATE MESYLATE

Generic name

DABIGATRAN ETEXILATE

Active ingredients

DABIGATRAN ETEXILATE MESYLATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

MSN

Manufacturer

Novadoz Pharmaceuticals LLC

First approval

2024-05-22

Source

Authoritative

Drugs@FDA application overview

Machine

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