FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

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Summary

FDA supplemental approval for mycophenolate mofetil (Sandoz) under an ANDA; the action updates labeling related to prevention of organ transplant rejection.

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Diseases / indications

• Heart Transplant Rejection Prophylaxis
• Kidney Transplant Rejection Prophylaxis
• Liver Transplant Rejection Prophylaxis

Drugs mentioned

• MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)

Snippet

SUPPL AP for MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)