FDA Orange Book · active-ingredient family
Amphotericin b
Amphotericin b: 6 brands, 10 generics; first approved Apr 13, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
10
Listed patents
0
Presentations
17
Brand (NDA) products
Originator applications
- ASTELLASNDA 0507401997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE, LIPOSOMAL INJECTION Rx AB - ABELCETRLDLEADIANT BIOSCI INCNDA 0507241995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE, LIPID COMPLEX INJECTION Discontinued — - ALKOPHARMA USANDA 05072919962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE, LIPID COMPLEX INJECTION Discontinued — 100MG/VIAL INJECTABLE, LIPID COMPLEX INJECTION Discontinued — - APOTHECONNDA 050314—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3% CREAM TOPICAL Discontinued — - APOTHECONNDA 050313—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3% OINTMENT TOPICAL Discontinued — - BRISTOL MYERS SQUIBBNDA 050341—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SUSPENSION ORAL Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- AMPHOTERICIN BMYLAN LABS LTDANDA 2129672025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE, LIPOSOMAL INJECTION Rx AB - AMPHOTERICIN BAVET LIFESCIENCESANDA 2153542025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE, LIPOSOMAL INJECTION Rx AB - AMPHOTERICIN BEUGIA PHARMAANDA 2140102022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE, LIPOSOMAL INJECTION Rx AB - AMPHOTERICIN BSPILANDA 2125142021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE, LIPOSOMAL INJECTION Rx AB - AMPHOTERICIN BABBOTTANDA 0641411996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — - AMPHOTERICIN BTEVA PARENTERALANDA 0640621995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — - AMPHOTERICIN BRSXGEN PHARMSANDA 0632061992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Rx — - AMPHOTERICIN BABRAXIS PHARMANDA 0627281987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — - APOTHECONANDA 060517—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — - APOTHECONANDA 060570—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3% LOTION TOPICAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
39 yr 11 mo ago
Most recent approval
1 yr 2 mo ago
Approvals span 1987–2025 across 16 FDA applications.
Brand (NDA) 638%
Generic (ANDA) 1063%
Amphotericin b: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
