The U.S. Food and Drug Administration has granted approval for application ANDA080711, covering a procaine hydrochloride injectable product. The product is administered by injection, classified as an injectable dosage form, and carries product number 001.
The formulation contains 1% procaine hydrochloride as the active ingredient. It is not designated as a reference drug or reference standard, and its marketing status is listed as discontinued.
The sponsor for this ANDA is BEL MAR. The submission was an original (ORIG) filing, submission number 1, and received an approved (AP) status on December 3, 1973.
規制動向2026年8月30日•1分で読めます
FDA Approves ANDA080711 for Procaine Hydrochloride Injection
The FDA approved ANDA080711 for a procaine hydrochloride injectable product by BEL MAR. The original submission was approved on Dec 3 1973 and the product is listed as discontinued.
PharmaCountryチームがまとめました · 出典： FDA.gov
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