Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050111
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UNIPEN NAFCILLIN SODIUM EQ 250MG BASE CAPSULE;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
04/07/1970 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
07/30/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/28/1987 SUPPL-26 Labeling

Label is not available on this site.

01/20/1987 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/05/1986 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1985 SUPPL-23 Efficacy-New Indication

Label is not available on this site.

12/28/1982 SUPPL-22 Labeling

Label is not available on this site.

10/02/1980 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/24/1978 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1977 SUPPL-19 Labeling

Label is not available on this site.

02/11/1977 SUPPL-18 Labeling

Label is not available on this site.

01/27/1976 SUPPL-17 Labeling

Label is not available on this site.

10/03/1975 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/19/1975 SUPPL-15 Labeling

Label is not available on this site.

06/24/1974 SUPPL-14 Labeling

Label is not available on this site.

05/13/1974 SUPPL-13 Labeling

Label is not available on this site.

03/27/1974 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1974 SUPPL-11 Labeling

Label is not available on this site.

03/08/1974 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1974 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1974 SUPPL-8 Labeling

Label is not available on this site.

08/14/1973 SUPPL-7 Labeling

Label is not available on this site.

04/10/1991 SUPPL-6 Labeling

Label is not available on this site.

07/24/1973 SUPPL-5 Labeling

Label is not available on this site.

08/01/1972 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1971 SUPPL-3 Labeling

Label is not available on this site.

10/22/1971 SUPPL-2 Labeling

Label is not available on this site.

04/22/1971 SUPPL-1 Labeling

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