← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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