← FDA Drug Approvals (Drugs@FDA)

NINTEDANIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EUGIA PHARMA SPECLTS · Approved 2026-02-04

Drug application

FDA Application #

ANDA215123

Application type

Abbreviated New Drug Application (Generic)

Brand name

NINTEDANIB

Generic name

Nintedanib

Active ingredients

NINTEDANIB

Dosage form

CAPSULE

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

EUGIA PHARMA SPECLTS

First approval

2026-02-04

Source

Authoritative

Drugs@FDA application overview

Machine

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