IMPAX LABS

Impax Labs' Digoxin ANDA: Analyzing the Discontinued Generic and Ongoing Regulatory Activity

Impax Labs' ANDA078556 for generic Digoxin (0.125MG, 0.25MG tablets) received original approval on July 20, 2009, but its products are now discontinued. This analysis details the regulatory history, including a recent labeling approval on February 9, 2026, and its implications for procurement and supply chain resilience, emphasizing the need for alternative sourcing strategies for this critical cardiac glycoside.