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GEMCITABINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND · Approved 2016-01-05

Drug application

FDA Application #
ANDA204520
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
Prescription
Sponsor
GLAND
Manufacturer
Gland Pharma Limited
First approval
2016-01-05

Source

Authoritative
Drugs@FDA application overview
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