Regulatory UpdatesSep 25, 2026•1 min read

FDA Approves Chartwell Allopurinol Generic (ANDA077353)

By the PharmaCountry team

FDA has approved Chartwell RX's generic allopurinol tablets (100 mg and 300 mg) under ANDA 077353, confirming prescription status and labeling updates.

The U.S. Food and Drug Administration has granted approval for a generic version of allopurinol, submitted under ANDA 077353. The product is manufactured by Chartwell RX, LLC and will be marketed as prescription tablets. The approved dosage forms are oral tablets containing 100 mg and 300 mg of allopurinol. Both strengths are listed under the brand name “ALLOPURINOL” with product numbers 001 and 002. The FDA submission history includes an original approval on September 8 2005 and labeling supplements filed on March 19 2019 and March 19 2025.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#allopurinol #FDA #ANDA #generic drug #Chartwell #prescription