Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074315
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Discontinued None No No
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Discontinued None No No
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No
TERAZOSIN HYDROCHLORIDE 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
12/31/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2003 SUPPL-11 Labeling

Label is not available on this site.

03/05/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/06/2000 SUPPL-3 Labeling

Label is not available on this site.

04/06/2000 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/07/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/31/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_prntlbl.pdf

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