Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018031
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDERIDE-40/25 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 25MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
INDERIDE-80/25 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
06/15/1979 ORIG-1 Approval Type 4 - New Combination 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
03/17/2011 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018031s037,s038ltr.pdf
03/17/2011 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018031s037,s038ltr.pdf
03/04/2010 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018031s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018031s036ltr.pdf
01/02/2008 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018031s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018031s035ltr.pdf
02/21/2007 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s077;018031s034ltr.pdf
12/29/2006 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018031s033ltr.pdf
06/09/2004 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18031slr032ltr.pdf
05/03/2001 SUPPL-31 Labeling

Label is not available on this site.

11/01/2001 SUPPL-30 Labeling

Label is not available on this site.

11/07/1997 SUPPL-29 Labeling

Label is not available on this site.

06/14/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/09/1989 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/1989 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/10/1989 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1988 SUPPL-24 Labeling

Label is not available on this site.

05/25/1988 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/30/1986 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/24/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1990 SUPPL-18 Efficacy-New Dosing Regimen

Label is not available on this site.

02/08/1990 SUPPL-17 Labeling

Label is not available on this site.

02/22/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1982 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/09/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1982 SUPPL-11 Labeling

Label is not available on this site.

01/26/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/03/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/19/1980 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/12/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1980 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/28/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1979 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2011 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf
03/17/2011 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf
03/04/2010 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018031s036lbl.pdf
01/02/2008 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018031s035lbl.pdf

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