# AFATINIB DIMALEATE
> **ANDA210725** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2026-07-14
## Drug
- **FDA Application Number:** ANDA210725
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** AFATINIB DIMALEATE
- **Generic name:** Afatinib Dimaleate
- **Active ingredients:** AFATINIB DIMALEATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** APOTEX
- **First approval:** 2026-07-14
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210725)
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*MORVS · CC0 1.0*