The U.S. Food and Drug Administration (FDA) issued an approval letter for ANDA 078713 on July 18, 2008. The application, submitted by Hikma, covers an injectable product containing Indomethacin Sodium (equivalent to 1 mg base per vial). The product is classified as an injection (route: INJECTION) and its dosage form is listed as INJECTABLE. The submission was an original (ORIG) filing and the approval status is recorded as AP. Despite the approval, the marketing status of the product is noted as Discontinued.
法规动态2026年9月18日•3 分钟阅读
FDA Approves Hikma’s Indomethacin Sodium Injection (ANDA 078713)
The FDA has approved ANDA 078713 for Hikma’s injectable Indomethacin Sodium, though the product is listed as discontinued.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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