Afatinib Dimaleate

Treats metastatic non-small cell lung cancer (NSCLC). ANDA 210750, held by Hetero Labs Ltd V. Afatinib Dimaleate.

As of Nov 15, 2026, ANDA 210750 (Afatinib Dimaleate), held by Hetero Labs Ltd V, was first approved by FDA on Jul 14, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Afatinib tablets are a kinase inhibitor indicated for:

First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test Limitations of Use: Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations
Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jul 14, 2026	Original application	Approved	None posted

Products

3 strengths and forms


Afatinib DimaleateEQ 20MG BASE · tablet;oral	Afatinib Dimaleate	Rx
Afatinib DimaleateEQ 30MG BASE · tablet;oral	Afatinib Dimaleate	Rx
Afatinib DimaleateEQ 40MG BASE · tablet;oral	Afatinib Dimaleate	Rx

Identifiers

Application: ANDA 210750
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters