The U.S. Food and Drug Administration has approved application ANDA077373 submitted by Sun Pharm Inds for octreotide acetate injectable products.
The ANDA lists two injectable products (product numbers 001 and 002) with strengths EQ 0.2 mg base/mL and EQ 1 mg base/mL, respectively. Both products are marked as discontinued.
The original submission (submission 1) received approval on August 14, 2007. Subsequent supplemental labeling submissions (numbers 3 and 8) were approved on January 31, 2013 and June 28, 2017.
No reference drug or reference standard was indicated for these products.
法规动态2026年9月15日•3 分钟阅读
FDA Approves Sun Pharm ANDA077373 for Octreotide Acetate Injectable Products
FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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