Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Final Resolution of Dockets

Resumen

The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough, cold, or allergy, Docket Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N- 0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), have been withdrawn. Therefore, shipment in interstate commerce of the products identified in those dockets, or any identical, related, or similar (IRS) product that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice.