Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062670
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL 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
06/18/1987 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
07/15/1997 SUPPL-17 Labeling

Label is not available on this site.

06/26/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/27/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-14 Labeling

Label is not available on this site.

06/13/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/29/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/08/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/07/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/12/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/24/1992 SUPPL-6 Labeling

Label is not available on this site.

04/28/1989 SUPPL-5 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