1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter D - DRUGS FOR HUMAN USE
  5. Part 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
  6. Subpart B - Administrative Procedures
  7. 21 CFR § 330.11
21 CFR § 330.11
NDA deviations from applicable monograph
June 25, 2020
CFR

A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that has become final shall be in the form required by §314.50 of this chapter, but shall include a statement that the product meets all conditions of the applicable monograph except for the deviation for which approval is requested and may omit all information except that pertinent to the deviation.

[39 FR 11741, Mar. 29, 1974, as amended at 55 FR 11581, Mar. 29, 1990]

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§ 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions
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§ 330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI)

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