Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 063206
Company: X GEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/29/1992 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/05/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/17/2009 SUPPL-16 Labeling

Label is not available on this site.

02/11/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1999 SUPPL-6 Labeling

Label is not available on this site.

09/18/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/19/1996 SUPPL-4 Labeling

Label is not available on this site.

03/15/1995 SUPPL-3 Labeling

Label is not available on this site.

01/17/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1994 SUPPL-1 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English