Assyro AI

Orange Book product · Brand (NDA)

AMPHOTEC

AMPHOTERICIN B

Brand (NDA)NDA 050729DISCN ALKOPHARMA USA
View AMPHOTERICIN B familyOpen on FDA Orange Book

At a glance

Nov 22, 1996

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 22, 1996

    30 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

AMPHOTERICIN B

Strength

100MG/VIAL

Dosage form

INJECTABLE, LIPID COMPLEX

Route

INJECTION

TE code

Not listed

Application

NDA 050729

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.

Agent CTA Background

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

Book a Demo