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Regulatorische Updates25. Sept. 2026•1 Min. Lesezeit

FDA Discontinues Testosterone Enanthate Injectable Products (ANDA083667)

Vom PharmaCountry-Team

The FDA has discontinued two injectable testosterone enanthate products from Watson Labs, listed under ANDA083667.

The U.S. Food and Drug Administration (FDA) has issued a discontinuation notice for two injectable testosterone enanthate products submitted by Watson Labs under application number ANDA083667. Both products are classified as injectables and carry the brand name "TESTOSTERONE ENANTHATE." Product number 001 is formulated at a strength of 100 MG/ML, while product number 002 is formulated at 200 MG/ML. Neither product is designated as a reference drug or reference standard, and both are now marked with a marketing status of "Discontinued." These changes reflect the FDA's current regulatory status for these specific testosterone enanthate injectables and should be noted by stakeholders monitoring product availability and compliance.

Zusammengestellt vom PharmaCountry-Team · Quelle: FDA.gov