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DABIGATRAN ETEXILATE MESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS USA · Approved 2017-04-19

Drug application

FDA Application #

ANDA208057

Application type

Abbreviated New Drug Application (Generic)

Brand name

DABIGATRAN ETEXILATE MESYLATE

Generic name

Dabigatran Etexilate Mesylate

Active ingredients

DABIGATRAN ETEXILATE MESYLATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

TEVA PHARMS USA

First approval

2017-04-19

Source

Authoritative

Drugs@FDA application overview

Machine

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