Selegiline Hydrochloride Tablet
FDA Label NDC 72319-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by I3 Pharmaceuticals, Llc for the product Selegiline Hydrochloride (NDC 72319-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, clinical pharmacology, rationale for the use of a selective monoamine oxidase type b inhibitor in parkinson’s disease, pharmacokinetic information (absorption, distribution, metabolism and elimination - adme), renal impairment, hepatic impairment, age, gender, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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