FDA Approves NDA011960 for ARISTOCORT Oral Syrup (Triamcinolone Acetate)

The U.S. Food and Drug Administration has approved application NDA011960 for the oral syrup product ARISTOCORT. The product is formulated as a syrup (route: oral) containing Triamcinolone Acetate at a strength of 2 mg per 5 mL. The sponsor for this application is Astellas. ARISTOCORT’s marketing status is recorded as discontinued. The FDA submission history includes multiple manufacturing (CMC) and labeling submissions: submission numbers 11 and 13 (manufacturing) approved on 1979‑02‑26 and 1992‑02‑06 respectively, and submission number 12 (labeling) approved on 1993‑11‑02. An original Type 3 new dosage form submission (number 1) was approved on 1959‑09‑02. No reference drug or reference standard was indicated for this product.