The U.S. Food and Drug Administration has approved an abbreviated new drug application (ANDA) numbered 078305 submitted by Fougera Pharms. The approval covers a prescription‑only topical solution containing 0.005 % calcitriene (CALCIPOTRIENE).
The product is identified as CALCIPOTRIENE, a topical solution (route: TOPICAL) with dosage form SOLUTION. The submission was an original (ORIG) filing, with the approval letter dated May 8 2008 (document ID 9140). The FDA listed the submission status as AP on May 6 2008. The approval letter can be accessed via the FDA website.
規制動向2026年9月13日•3分で読めます
Fougera Pharms Receives FDA Approval for CALCIPOTRIENE Topical Solution (ANDA 078305)
The FDA has approved Fougera Pharms' CALCIPOTRIENE 0.005% topical solution under ANDA 078305, a new prescription product.
Pharmacountryチームがまとめました · 出典： FDA.gov
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