FDA Approves Buprenex Labeling Update.pdf

18401s014ltr.pdf
Preview of FDA Approves Buprenex Labeling Update
🔗 Source: accessdata.fda.gov
📊 Size: 128 KB
👤 Author: Sara Shepherd
⬇️ Downloads: 21

Summary

- Document Type: FDA approval letter for a supplemental new drug application (NDA 18-401/S-014)
- Product: Buprenex (buprenorphine hydrochloride) Injectable
- Applicant: Reckitt Benckiser Pharmaceuticals, Inc.
- Submission Date: November 16, 2001
- Review Outcome: Approved
- Effective Date: February 11, 2002
- Changes: Updated "Drug Interactions" and "Carcinogenesis, Mutagenesis and Impairment of Fertility" subsections in PRECAUTIONS section, and carton/container labels reflecting new company name
- Labeling Requirements: Final printed labeling (FPL) must match submitted draft labeling. Submit FPL electronically or 20 paper copies, with 10 mounted, within 30 days of printing
- Compliance: Must adhere to 21 CFR 314.80 and 314.81
- Contact: Sara Shepherd, Project Manager, (301) 827-7430
- Signatory: Cynthia McCormick, M.D., Director, Division of Anesthetic, Critical Care, and Addiction Drug Products

Description

We acknowledge receipt of your supplemental new drug application dated November 16, 2001, received November 26, 2001. This application provides revisions to the "Drug Interactions" and "Carcinogenesis, Mutagenesis and Impairment of Fertility" subsections of the PRECAUTIONS section. We have completed the review of this supplemental application.

Technical Information

  • File Format: PDF
  • File Size: 128 KB
  • Pages: 3
  • Language: EN
  • Author: Sara Shepherd
  • Total Downloads: 21
  • Last Updated: 2 months ago

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