FDA
Amphotericin B
The FDA lists this product in 8 strengths and forms.
Composition
- Active ingredients
- AMPHOTERICIN B 50MG/VIAL
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- AMPHOTERICIN B 50MG/VIAL · Injectable, liposomalANDA214010-001 · Prescription
- AMPHOTERICIN B 50MG/VIAL · InjectableANDA063206-001 · Prescription
- AMPHOTERICIN B 50MG/VIAL · InjectableANDA064141-001 · Discontinued
- AMPHOTERICIN B 50MG/VIAL · InjectableANDA064062-001 · Discontinued
- AMPHOTERICIN B 50MG/VIAL · Injectable, liposomalThis page
- AMPHOTERICIN B 50MG/VIAL · Injectable, liposomalANDA215354-001 · Prescription
- AMPHOTERICIN B 50MG/VIAL · InjectableANDA062728-001 · Discontinued
- AMPHOTERICIN B 50MG/VIAL · Injectable, liposomalANDA212514-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA212967.
At a glance
- Brand name
- Amphotericin B
- Route
- Injection
- Dosage form
- Injectable, liposomal
- Applicant
- Mylan Labs LTD
- Status
- Prescription
- FDA approval
- 30 Jun 2025
- Application
- ANDA212967-001