Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019032
Company: PROMIUS PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENEX GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Discontinued None Yes No
TENEX GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Discontinued None Yes No
TENEX GUANFACINE HYDROCHLORIDE EQ 3MG 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
10/27/1986 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
07/03/2013 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.

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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