Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018104
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYLOREL GUANADREL SULFATE 10MG TABLET;ORAL Discontinued None No No
HYLOREL GUANADREL SULFATE 25MG 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
12/29/1982 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
08/01/1990 SUPPL-7 Labeling

Label is not available on this site.

08/01/1990 SUPPL-6 Labeling

Label is not available on this site.

10/07/1986 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/20/1985 SUPPL-4 Labeling

Label is not available on this site.

08/20/1985 SUPPL-3 Labeling

Label is not available on this site.

09/13/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1983 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