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GEMCITABINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MEITHEAL · Approved 2020-12-11

Drug application

FDA Application #
ANDA212129
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
MEITHEAL
Manufacturer
Meitheal Pharmaceuticals Inc.
First approval
2020-12-11

Source

Authoritative
Drugs@FDA application overview
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