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.
Regulatorische Updates13. Sept. 2026•3 Min. Lesezeit
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.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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