Regulatory UpdatesSep 25, 2026•1 min read

FDA Marks PANRAY's THEOLIXIR Oral Elixir as Discontinued (ANDA084559)

By the PharmaCountry team

The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.

The U.S. Food and Drug Administration (FDA) has recorded the status of product THEOLIXIR under application number ANDA084559. THEOLIXIR is an oral elixir (route: ORAL) marketed by sponsor PANRAY. The product contains the active ingredient THEOPHYLLINE at a strength of 80 mg per 15 mL. According to the FDA filing, the marketing status of THEOLIXIR is listed as discontinued. No reference drug or reference standard is associated with this filing.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #discontinued #Oral #Theophylline #pharma