Orange Book product · Brand (NDA)
FUNGIZONE
AMPHOTERICIN B
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
AMPHOTERICIN B
Strength
100MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050341
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1997AMBISOMEBrand (NDA)
NDA 050740 · ASTELLAS
- 1996AMPHOTECBrand (NDA)
NDA 050729 · ALKOPHARMA USA
- 1995ABELCETBrand (NDA)
NDA 050724 · LEADIANT BIOSCI INC
- —FUNGIZONEBrand (NDA)
NDA 050314 · APOTHECON
- —FUNGIZONEBrand (NDA)
NDA 050313 · APOTHECON
- 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.
