← FDA Drug Approvals (Drugs@FDA)
NINTEDANIB ESYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS · Approved 2026-08-03
Drug application
- FDA Application #
ANDA219926- 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
- MACLEODS PHARMS
- Manufacturer
- Macleods Pharmaceuticals Limited
- First approval
- 2026-08-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown