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Format & content for new OTC drug products (included FDA recommendations on statutory requirements)
General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions
FFDCA Sec 502 - 21 USC 352
Format & content for new OTC drug products (included FDA recommendations on statutory requirements)
OMB: 0910-0340
OMB.report
HHS/FDA
OMB 0910-0340
ICR 202212-0910-002
IC 5943
Format & content for new OTC drug products (included FDA recommendations on statutory requirements)
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⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0340 can be found here:
2023-10-27 - Revision of a currently approved collection
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