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.
規制動向2026年9月17日•3分で読めます
FDA Approves NDA011960 for ARISTOCORT Oral Syrup (Triamcinolone Acetate)
The FDA approved NDA011960 for ARISTOCORT oral syrup, a 2 mg/5 mL Triamcinolone Acetate product by Astellas, now listed as discontinued.
Pharmacountryチームがまとめました · 出典： FDA.gov
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