← FDA Drug Approvals (Drugs@FDA)
BOSUTINIB MONOHYDRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2025-05-23
Drug application
- FDA Application #
ANDA209543- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BOSUTINIB MONOHYDRATE
- Generic name
- Bosutinib Monohydrate
- Active ingredients
- BOSUTINIB MONOHYDRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALEMBIC
- First approval
- 2025-05-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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