Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020347
Company: ABBOTT

Products on NDA 020347

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HYTRIN	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
HYTRIN	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
HYTRIN	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
HYTRIN	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020347

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.

Labels for NDA 020347

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