Regulatory Updates
Sep 25, 2026•1 min read
FDA Marks PANRAY's THEOLIXIR Oral Elixir as Discontinued (ANDA084559)
The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for SLO‑BID (Theophylline 50 mg)
The FDA has approved a series of manufacturing (CMC) and labeling submissions for SLO‑BID, an oral extended‑release theophylline capsule, now listed as discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA ANDA084751 Approval for DILOR-400 (400 mg Theophylline)
DILOR-400, an oral tablet containing 400 mg theophylline, was approved under ANDA084751 with multiple manufacturing supplements; the product is currently discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA084731 for Theophylline Oral Capsules (Discontinued)
The FDA has approved ANDA084731 for Theophylline capsules in 100 mg, 200 mg and 250 mg strengths. All three products are listed as discontinued by sponsor Scherer RP.