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GEMCITABINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2011-05-17

Drug application

FDA Application #

ANDA090242

Application type

Abbreviated New Drug Application (Generic)

Brand name

GEMCITABINE HYDROCHLORIDE

Generic name

Gemcitabine Hydrochloride

Active ingredients

GEMCITABINE HYDROCHLORIDE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

None (Tentative Approval)

Sponsor

FRESENIUS KABI USA

First approval

2011-05-17

Source

Authoritative

Drugs@FDA application overview

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