FDA Approval Letter.pdf

20992s11ltr.pdf
Preview of FDA Approval Letter
🔗 Source: accessdata.fda.gov
📊 Size: 124 KB
👤 Author: Diane V. Moore
⬇️ Downloads: 31

Summary

The FDA approved a supplemental new drug application for Cenestin (synthetic conjugated estrogens) 0.625 mg, 0.9 mg, and 1.25 mg Tablets, revising the WARNINGS, PRECAUTIONS, and DANGERS OF ESTROGENS sections of the package insert, effective as of the letter date, and reminds the applicant to comply with requirements for an approved NDA.

Description

The FDA approved a supplemental new drug application for Cenestin (synthetic conjugated estrogens) 0.625 mg, 0.9 mg, and 1.25 mg Tablets, revising the...

Technical Information

  • File Format: PDF
  • File Size: 124 KB
  • Pages: 3
  • Language: EN
  • Author: Diane V. Moore
  • Total Downloads: 31
  • Last Updated: 1 week ago

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