Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval.
在OTC类药物专著系统规定内，FDA允许一些OTC药物在没有获得批准前上市。
Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
如果制药公司希望标记OT C但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。
Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
如果制药公司希望标记OT C但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。
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