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DABIGATRAN ETEXILATE MESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2020-05-06

Drug application

FDA Application #

ANDA207961

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

HETERO LABS LTD III

Manufacturer

XLCare Pharmaceuticals, Inc.

First approval

2020-05-06

Source

Authoritative

Drugs@FDA application overview

Machine

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