General MedicationsTABLETGeneric
AFATINIB
AFATINIB
Standard Dose
20MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview AFATINIB is listed in Drugs@FDA under application 210703 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AFATINIB Form and strength TABLET - 20MG Sponsor SANDOZ INC Submission history Latest submission status date: 2026-01-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview AFATINIB is listed in Drugs@FDA under application 210703 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AFATINIB Form and strength TABLET - 20MG Sponsor SANDOZ INC Submission history Latest submission status date: 2026-01-09 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.