Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019057
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Discontinued None No No
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Discontinued None No No
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 10MG 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
08/07/1987 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
07/10/2009 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019057s022ltr.pdf
02/06/2006 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019057Orig1s021,020347Orig1s009 ltr.pdf
12/24/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/2002 SUPPL-15 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19057s15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-057-S015.pdf
08/06/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1998 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1996 SUPPL-11 Labeling

Label is not available on this site.

07/11/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/14/1994 SUPPL-8 Labeling

Label is not available on this site.

06/17/1994 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1993 SUPPL-6 Labeling

Label is not available on this site.

08/20/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1991 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1990 SUPPL-3 Labeling

Label is not available on this site.

09/20/1988 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/10/2009 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf
02/06/2006 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf

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