Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 061954
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCO-TRIACET II NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% 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
09/20/1985 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
08/30/2001 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

08/19/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/31/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/13/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/12/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/05/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/05/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/05/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/30/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/15/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/04/1993 SUPPL-12 Labeling

Label is not available on this site.

08/10/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/13/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/16/1988 SUPPL-7 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