Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050462
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UNIPEN NAFCILLIN SODIUM EQ 500MG BASE TABLET;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
10/16/1973 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/03/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1980 SUPPL-19 Labeling

Label is not available on this site.

04/24/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1977 SUPPL-17 Labeling

Label is not available on this site.

06/02/1977 SUPPL-16 Labeling

Label is not available on this site.

04/21/1976 SUPPL-15 Labeling

Label is not available on this site.

03/23/1975 SUPPL-14 Labeling

Label is not available on this site.

08/19/1975 SUPPL-13 Labeling

Label is not available on this site.

11/22/1976 SUPPL-11 Labeling

Label is not available on this site.

04/11/1974 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1974 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1974 SUPPL-8 Labeling

Label is not available on this site.

04/10/1991 SUPPL-7 Labeling

Label is not available on this site.

09/28/1987 SUPPL-6 Labeling

Label is not available on this site.

01/20/1987 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/05/1986 SUPPL-4 Labeling

Label is not available on this site.

11/21/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1982 SUPPL-2 Labeling

Label is not available on this site.

12/14/1982 SUPPL-1 Manufacturing (CMC)-Control

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