← FDA Drug Approvals (Drugs@FDA)
NILOTINIB HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD V · Approved 2025-11-19
Drug application
- FDA Application #
ANDA209651- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NILOTINIB HYDROCHLORIDE
- Generic name
- NILOTINIB
- Active ingredients
- NILOTINIB HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HETERO LABS LTD V
- Manufacturer
- Camber Pharmaceuticals, Inc.
- First approval
- 2025-11-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown