Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074149
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GUANABENZ ACETATE GUANABENZ ACETATE EQ 4MG BASE TABLET;ORAL Prescription None No No
GUANABENZ ACETATE GUANABENZ ACETATE EQ 8MG BASE TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/07/1995 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
07/29/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

05/27/1999 SUPPL-5 Labeling

Label is not available on this site.

05/27/1999 SUPPL-4 Labeling

Label is not available on this site.

07/14/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-2 Labeling

Label is not available on this site.

07/14/1995 SUPPL-1 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