Orasone

ANDA 83009, held by Solvay. Prednisone.

As of Nov 14, 2026, ANDA 83009 (Orasone), held by Solvay, was first approved by FDA on Jan 29, 1974, with 0 approved supplements and 0 published complete response letters.

• First approved: Jan 29, 1974
• Supplements approved: 0
• Complete response letters: 0

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters