Actualités réglementaires25 sept. 2026•1 min de lecture

FDA Approves Chartwell Allopurinol Generic (ANDA077353)

Par l'équipe PharmaCountry

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.

Compilé par l'équipe PharmaCountry · Source : FDA.gov

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