Active ingredient
Amphotericin B
6 finished FDA listings contain Amphotericin B as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- AMPHOTERICIN B
- Dosage forms
- Injectable, Liposomal, Injection, Powder, Lyophilized, For Solution, Injection, Powder, Lyophilized, For Suspension
- Routes
- Intravenous
- Manufacturers / labelers
- 5
- Strengths listed
- 50 mg/1 · 50 mg/10ml · 50 mg/12.5ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 732
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 063206 | XGEN PHARMS | 1992-04-29 | 1 |
| ANDA 212514 | SPIL | 2021-12-14 | 2 |
| ANDA 214010 | EUGIA PHARMA | 2022-11-17 | 1 |
| ANDA 215354 | AVET LIFESCIENCES | 2025-06-02 | 1 |
| ANDA 212967 | MYLAN LABS LTD | 2025-06-30 | 1 |
Official labeling on DailyMed
- AMPHOTERICIN B INJECTABLE, LIPOSOMAL [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 3 · 2026-04-22
- AMPHOTERICIN B INJECTABLE, LIPOSOMAL [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2026-04-22
- AMPHOTERICIN B LIPOSOME INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [MYLAN INSTITUTIONAL LLC] · version 1 · 2025-08-08
- AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] · version 2 · 2025-07-07
- AMPHOTERICIN B INJECTABLE, LIPOSOMAL [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 4 · 2025-06-23
- AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] · version 13 · 2022-01-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.