← FDA Drug Approvals (Drugs@FDA)

GEMCITABINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EUROHLTH INTL · Approved 2010-01-19

Drug application

FDA Application #

ANDA078460

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

EUROHLTH INTL

First approval

2010-01-19

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown