Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 085208 for Hydrochlorothiazide 50 mg Oral Tablet (Discontinued)
The FDA approved ANDA 085208 for a 50 mg oral tablet of hydrochlorothiazide, now marked as discontinued, with supplemental manufacturing and labeling approvals spanning 1981‑2020.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Issues ANDA084743 for Inwood Labs' Phendimetrazine Tartrate Tablet (Discontinued)
The FDA has listed ANDA084743 for Inwood Labs' oral tablet of Phendimetrazine Tartrate (35 mg), currently marked as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
Mylan's GLIMEPIRIDE ANDA077486 Receives FDA Approval
The FDA approved Mylan's ANDA077486 for GLIMEPIRIDE tablets (1mg, 2mg, 4mg), though all listed products are marked as discontinued.
Regulatory Updates
Aug 27, 2026•1 min read
FDA Approves ANDA077507 for Glipizide and Metformin Hydrochloride Tablets
The FDA has approved ANDA077507, a generic oral tablet combining glipizide and metformin hydrochloride in three strengths, submitted by EPIC PHARMA LLC.