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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019032
Company: PROMIUS PHARMA

Products on NDA 019032

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TENEX	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TENEX	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TENEX	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019032

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/1986	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019032Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2013	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019032s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019032Orig1s021ltr.pdf
03/12/2002	SUPPL-17	Labeling	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19032s16s17ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-032s16s17_Tenex.cfm
03/12/2002	SUPPL-16	Labeling	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19032s16s17ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-032s16s17_Tenex.cfm
01/13/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/17/1991	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
03/01/1991	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/29/1989	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
02/01/1990	SUPPL-11	Labeling		Label is not available on this site.
05/11/1993	SUPPL-10	Efficacy-New Indication		Label is not available on this site.
11/07/1988	SUPPL-9	Labeling		Label is not available on this site.
06/09/1988	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/07/1988	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
12/28/1987	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/20/1987	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/29/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/17/1987	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/17/1987	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019032

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2013	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019032s021lbl.pdf

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