AmBisome - 0469-3051-30 - (amphotericin B)

Alphabetical Index


Drug Information of AmBisome

Product NDC: 0469-3051
Proprietary Name: AmBisome
Non Proprietary Name: amphotericin B
Active Ingredient(s): 50    mg/12.5mL & nbsp;   amphotericin B
Administration Route(s): INTRAVENOUS
Dosage Form(s): INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of AmBisome

Product NDC: 0469-3051
Labeler Name: Astellas Pharma US, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA050740
Marketing Category: NDA
Start Marketing Date: 19970811

Package Information of AmBisome

Package NDC: 0469-3051-30
Package Description: 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)

NDC Information of AmBisome

NDC Code 0469-3051-30
Proprietary Name AmBisome
Package Description 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)
Product NDC 0469-3051
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name amphotericin B
Dosage Form Name INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route Name INTRAVENOUS
Start Marketing Date 19970811
Marketing Category Name NDA
Labeler Name Astellas Pharma US, Inc.
Substance Name AMPHOTERICIN B
Strength Number 50
Strength Unit mg/12.5mL
Pharmaceutical Classes Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]

Complete Information of AmBisome


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