← FDA Drug Approvals (Drugs@FDA)
OSIMERTINIB MESYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2021-06-01
Drug application
- FDA Application #
ANDA214263- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OSIMERTINIB MESYLATE
- Generic name
- Osimertinib Mesylate
- Active ingredients
- OSIMERTINIB MESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- ZYDUS PHARMS USA INC
- First approval
- 2021-06-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown