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NINTEDANIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD · Approved 2026-03-05

Drug application

FDA Application #
ANDA218472
Application type
Abbreviated New Drug Application (Generic)
Brand name
NINTEDANIB
Generic name
Nintedanib
Active ingredients
NINTEDANIB
Dosage form
CAPSULE
Route
—
Marketing status
None (Tentative Approval)
Sponsor
HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD
First approval
2026-03-05

Source

Authoritative
Drugs@FDA application overview
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