Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020347
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
HYTRIN TERAZOSIN HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
12/14/1994 ORIG-1 Approval Type 3 - New Dosage Form 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
02/06/2006 SUPPL-9 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
10/04/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/2002 SUPPL-6 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/2002/20-347-S006.pdf
08/06/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1998 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1996 SUPPL-2 Labeling

Label is not available on this site.

03/14/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf

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