Orange Book product · Brand (NDA)
AMBISOME
AMPHOTERICIN B
At a glance
Aug 11, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 11, 1997
29 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
AMPHOTERICIN B
Strength
50MG/VIAL
Dosage form
INJECTABLE, LIPOSOMAL
Route
INJECTION
TE code
AB
Application
NDA 050740
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1996AMPHOTECBrand (NDA)
NDA 050729 · ALKOPHARMA USA
- 1995ABELCETBrand (NDA)
NDA 050724 · LEADIANT BIOSCI INC
- —FUNGIZONEBrand (NDA)
NDA 050314 · APOTHECON
- —FUNGIZONEBrand (NDA)
NDA 050313 · APOTHECON
- —FUNGIZONEBrand (NDA)
NDA 050341 · BRISTOL MYERS SQUIBB
- 2025AMPHOTERICIN BGeneric (ANDA)
ANDA 212967 · MYLAN LABS LTD
- 2025AMPHOTERICIN BGeneric (ANDA)
ANDA 215354 · AVET LIFESCIENCES
- 2022AMPHOTERICIN BGeneric (ANDA)
ANDA 214010 · EUGIA PHARMA
- 2021AMPHOTERICIN BGeneric (ANDA)
ANDA 212514 · SPIL
- 1996AMPHOTERICIN BGeneric (ANDA)
ANDA 064141 · ABBOTT
- 1995AMPHOTERICIN BGeneric (ANDA)
ANDA 064062 · TEVA PARENTERAL
- 1992AMPHOTERICIN BGeneric (ANDA)
ANDA 063206 · XGEN PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
