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NINTEDANIB ESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIOCON PHARMA · Approved 2026-08-19

Drug application

FDA Application #
ANDA220118
Application type
Abbreviated New Drug Application (Generic)
Brand name
NINTEDANIB ESYLATE
Generic name
Nintedanib Esylate
Active ingredients
NINTEDANIB ESYLATE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
BIOCON PHARMA
First approval
2026-08-19

Source

Authoritative
Drugs@FDA application overview
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