Tags

Type your tag names separated by a space and hit enter

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final rule for over-the-counter antitussive drug products; technical amendment. Final rule, technical amendment.
Fed Regist. 2007 Nov 30; 72(230):67639-40.FR

Abstract

The Food and Drug Administration (FDA) is amending its regulations (exemption for certain drugs limited by new-drug applications to prescription sale, and warning and caution statements required by regulations for drugs) by removing the entries for carbetapentane citrate. This action is associated with FDA's determination that carbetapentane citrate has not been shown to be effective at the over-the-counter (OTC) doses stated in the exempting regulation. FDA made this determination in 1987 as part of its ongoing review of OTC drug products.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Antitussive AgentsConsumer Product SafetyCyclopentanesDrug LabelingHumansNonprescription DrugsUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18064767

Citation

Food and Drug Administration, HHS. "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Final Rule for Over-the-counter Antitussive Drug Products; Technical Amendment. Final Rule, Technical Amendment." Federal Register, vol. 72, no. 230, 2007, pp. 67639-40.
Food and Drug Administration, HHS. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final rule for over-the-counter antitussive drug products; technical amendment. Final rule, technical amendment. Fed Regist. 2007;72(230):67639-40.
Food and Drug Administration, HHS. (2007). Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final rule for over-the-counter antitussive drug products; technical amendment. Final rule, technical amendment. Federal Register, 72(230), 67639-40.
Food and Drug Administration, HHS. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Final Rule for Over-the-counter Antitussive Drug Products; Technical Amendment. Final Rule, Technical Amendment. Fed Regist. 2007 Nov 30;72(230):67639-40. PubMed PMID: 18064767.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final rule for over-the-counter antitussive drug products; technical amendment. Final rule, technical amendment. A1 - ,, PY - 2007/12/11/pubmed PY - 2007/12/15/medline PY - 2007/12/11/entrez SP - 67639 EP - 40 JF - Federal register JO - Fed Regist VL - 72 IS - 230 N2 - The Food and Drug Administration (FDA) is amending its regulations (exemption for certain drugs limited by new-drug applications to prescription sale, and warning and caution statements required by regulations for drugs) by removing the entries for carbetapentane citrate. This action is associated with FDA's determination that carbetapentane citrate has not been shown to be effective at the over-the-counter (OTC) doses stated in the exempting regulation. FDA made this determination in 1987 as part of its ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/18064767/Cold_cough_allergy_bronchodilator_and_antiasthmatic_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -