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Business · 21/06/2000

FDA Clears the Way for Approval of Generic Paroxetine Hydrochloride Capsules

The Food and Drug Administration (FDA) has determined that paroxetine hydrochloride (Paxil) 10-, 20-, 30-, and 40-mg capsules were not withdrawn from sale due to safety or effectiveness concerns, paving the way for the approval of abbreviated new drug applications (ANDA's) for these formulations.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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