U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075453
Company: IVAX SUB TEVA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 1MG BASE TABLET;ORAL Discontinued None No No
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 2MG BASE TABLET;ORAL Discontinued None No No
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 4MG BASE TABLET;ORAL Discontinued None No No
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 8MG 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
10/18/2000 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75453ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75453TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2005 SUPPL-17 Labeling

Label is not available on this site.
07/29/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.
12/11/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/11/2002 SUPPL-5 Labeling

Label is not available on this site.
12/11/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.
12/11/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.
08/28/2002 SUPPL-2 Labeling

Label is not available on this site.
08/28/2002 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.
Back to Top