Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018587
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WYTENSIN GUANABENZ ACETATE EQ 4MG BASE TABLET;ORAL Discontinued None No No
WYTENSIN GUANABENZ ACETATE EQ 8MG BASE TABLET;ORAL Discontinued None No No
WYTENSIN GUANABENZ ACETATE EQ 16MG 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
09/07/1982 ORIG-1 Approval Type 1 - New Molecular Entity 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
11/27/2001 SUPPL-23 Labeling

Label is not available on this site.

07/23/1997 SUPPL-22 Labeling

Label is not available on this site.

07/31/1991 SUPPL-21 Labeling

Label is not available on this site.

01/25/1989 SUPPL-20 Labeling

Label is not available on this site.

09/22/1988 SUPPL-19 Labeling

Label is not available on this site.

04/08/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/1989 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1986 SUPPL-15 Labeling

Label is not available on this site.

03/26/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/04/1986 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/18/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1987 SUPPL-11 Labeling

Label is not available on this site.

12/18/1985 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1985 SUPPL-9 Labeling

Label is not available on this site.

09/26/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1984 SUPPL-5 Labeling

Label is not available on this site.

02/27/1984 SUPPL-4 Labeling

Label is not available on this site.

12/23/1983 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/21/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1983 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