Sciegen Pharmaceuticals Inc. has been granted a tentative approval (TA) by the U.S. Food and Drug Administration for an abbreviated new drug application (ANDA) numbered ANDA219408. The submission, classified as an original (ORIG) filing with standard review priority, was listed with a status date of 2026-04-30.
The ANDA covers two generic dapagliflozin tablet products: a 5 mg strength (product number 001) and a 10 mg strength (product number 002). Both products are listed as tablets, have no designated reference drug, and are currently marked as "None (Tentative Approval)" in marketing status. No reference standard was cited for either product.
These approvals allow Sciegen Pharmaceuticals to market the dapagliflozin tablets in the United States once any outstanding patent or exclusivity issues are resolved, pending final FDA approval.
法规动态2026年9月18日•3 分钟阅读
FDA Grants Tentative Approval for Dapagliflozin Tablets (ANDA219408)
Sciegen Pharmaceuticals received tentative FDA approval for 5 mg and 10 mg dapagliflozin tablets under ANDA219408.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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