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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
Labeling of nonRx drugs under NDCPA GFI Sept 2009
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⚠️ Notice: This form may be outdated.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:
2024-12-26 - Revision of a currently approved collection
2023-10-27 - Revision of a currently approved collection
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