
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 …
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 …
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 …
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) …
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 …
AmBisome - FDA Drug Approval Details - trial.medpath.com
Detailed FDA approval information for AmBisome, including regulatory status, product details, and official drug labeling information.
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 …
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
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 …
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 …