Assyro AI

FDA Orange Book · active-ingredient family

Amphotericin b

Amphotericin b is approved as 6 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AMBISOME · NDA 050740

6

Brand (NDA)

10

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, injectable, injectable, lipid complex, injectable, liposomal, lotion, ointment, suspension

ProductApplicantApplicationTEApproved
AMBISOMERLDASTELLASNDA 050740ABAug 11, 1997
ABELCETRLDLEADIANT BIOSCI INCNDA 050724—Nov 20, 1995
AMPHOTEC×2ALKOPHARMA USANDA 050729—Nov 22, 1996
FUNGIZONEAPOTHECONNDA 050314—Approved Prior to Jan 1, 1982
FUNGIZONEAPOTHECONNDA 050313—Approved Prior to Jan 1, 1982
FUNGIZONEBRISTOL MYERS SQUIBBNDA 050341—Approved Prior to Jan 1, 1982

Generic (ANDA) products (10)

ProductApplicantApplicationTEApproved
AMPHOTERICIN BMYLAN LABS LTDANDA 212967ABJun 30, 2025
AMPHOTERICIN BAVET LIFESCIENCESANDA 215354ABJun 02, 2025
AMPHOTERICIN BEUGIA PHARMAANDA 214010ABNov 17, 2022
AMPHOTERICIN BSPILANDA 212514ABDec 14, 2021
AMPHOTERICIN BABBOTTANDA 064141—Dec 23, 1996
AMPHOTERICIN BTEVA PARENTERALANDA 064062—Mar 31, 1995
AMPHOTERICIN BXGEN PHARMSANDA 063206—Apr 29, 1992
AMPHOTERICIN BABRAXIS PHARMANDA 062728—Apr 13, 1987
FUNGIZONEAPOTHECONANDA 060517—Approved Prior to Jan 1, 1982
FUNGIZONEAPOTHECONANDA 060570—Approved Prior to Jan 1, 1982

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.

Amphotericin b — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo