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GEFITINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: QILU PHARM HAINAN · Approved 2023-02-13

Drug application

FDA Application #

ANDA211591

Application type

Abbreviated New Drug Application (Generic)

Brand name

GEFITINIB

Generic name

GEFITINIB

Active ingredients

GEFITINIB

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

QILU PHARM HAINAN

Manufacturer

Ingenus Pharmaceuticals, LLC

First approval

2023-02-13

Source

Authoritative

Drugs@FDA application overview

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