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GEMCITABINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PARENTERAL · Approved 2009-12-08

Drug application

FDA Application #

ANDA090644

Application type

Abbreviated New Drug Application (Generic)

Brand name

GEMCITABINE

Generic name

Gemcitabine

Active ingredients

GEMCITABINE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

None (Tentative Approval)

Sponsor

TEVA PARENTERAL

First approval

2009-12-08

Source

Authoritative

Drugs@FDA application overview

Machine

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