Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050724
Company: SIGMA TAU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABELCET AMPHOTERICIN B 5MG/ML INJECTABLE, LIPID COMPLEX;INJECTION Prescription None Yes 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
11/20/1995 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/06/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/29/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1999 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/10/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/13/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-2 Efficacy-New Indication

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