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BENDAMUSTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2018-11-13

Drug application

FDA Application #

ANDA210410

Application type

Abbreviated New Drug Application (Generic)

Brand name

BENDAMUSTINE HYDROCHLORIDE

Generic name

Bendamustine Hydrochloride

Active ingredients

BENDAMUSTINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

IV (INFUSION)

Marketing status

None (Tentative Approval)

Sponsor

FRESENIUS KABI USA

First approval

2018-11-13

Source

Authoritative

Drugs@FDA application overview

Machine

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