Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050314
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUNGIZONE AMPHOTERICIN B 3% CREAM;TOPICAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/07/1966 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
06/13/1996 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1978 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1978 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1975 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1971 SUPPL-7 Labeling

Label is not available on this site.

05/07/1993 SUPPL-6 Manufacturing (CMC)

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