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FDA Warning Letter Explorer
FDA warning letter · Drugs

Aytu Biopharma

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to Use Required Established Name

Passage 2

Failure to Submit Under Form FDA-2253

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.10(g)(1)
  • 21 CFR 314.81(b)(3)(i)