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  1. Drug Approval Package: Ambisome (Amphotericin B) NDA# 050740

    Aug 11, 1997 · Ambisome (Amphotericin B) Company: Astellas Application No.: 050740 Approval Date: 8/11/1997 Approval Letter (s) and Medical Review Part 1) (PDF) Medical Review Part 2 …

  2. When was Ambisome approved by the FDA? Key Dates and History

    Nov 18, 2025 · The FDA approval of Ambisome on August 11, 1997, provided a safer, lipid-based alternative to conventional amphotericin B for treating serious fungal infections and visceral …

  3. Drug Administration, Rockville, Maryland In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral …

  4. FDA Approves AmBisome for the Treatment of Cryptococcal …

    Jul 5, 2000 · Deerfield, IL and Foster City, CA -- July 5, 2000 Fujisawa Healthcare, Inc. and Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) …

  5. FDA Approves New Indication for Antifungal Medication

    The U.S. Food and Drug Administration (FDA) has approved the antifungal drug AmBisome ( (amphotericin B) liposome for injection) for the treatment of cryptococcal meningitis in HIV …

  6. AmBisome - FDA Drug Approval Details - trial.medpath.com

    Detailed FDA approval information for AmBisome, including regulatory status, product details, and official drug labeling information.

  7. Pediatric patients, age 1 month to 16 years, with presumed fungal infection (empirical therapy), confirmed systemic fungal infections or with visceral leishmaniasis have been successfully …

  8. AMBISOME-美国FDA药品数据库-药物在线

    商品名:AMBISOME,活性成分:AMPHOTERICIN B,申请号:050740,申请人:ASTELLAS

  9. In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and Drug …

  10. U.S. Food and Drug Administration Approval of AmBisome (Liposomal ...

    Jan 1, 1999 · In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and …