Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016418
Company: WYETH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDERAL PROPRANOLOL HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
INDERAL PROPRANOLOL HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
INDERAL PROPRANOLOL HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
INDERAL PROPRANOLOL HYDROCHLORIDE 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
INDERAL PROPRANOLOL HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
INDERAL PROPRANOLOL HYDROCHLORIDE 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
11/13/1967 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

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-80 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016418s080,016762s017,017683s008ltr.pdf
05/06/2008 SUPPL-79 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016418s079ltr.pdf
09/06/2007 SUPPL-78 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s078_ltr.pdf
02/21/2007 SUPPL-77 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-76 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016418s076ltr.pdf
08/18/2004 SUPPL-73 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16418s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16418s073ltr.pdf
02/06/2002 SUPPL-72 Labeling

Label is not available on this site.

08/22/1999 SUPPL-71 Labeling

Label is not available on this site.

11/07/1997 SUPPL-70 Labeling

Label is not available on this site.

02/15/1990 SUPPL-69 Labeling

Label is not available on this site.

03/30/1989 SUPPL-68 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/25/1988 SUPPL-67 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/20/1987 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1985 SUPPL-64 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/28/1985 SUPPL-63 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/20/1984 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1985 SUPPL-61 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/21/1984 SUPPL-58 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/22/1985 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

01/12/1984 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1985 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1983 SUPPL-54 Labeling

Label is not available on this site.

01/07/1983 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1982 SUPPL-52 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/31/1986 SUPPL-51 Efficacy-New Indication

Label is not available on this site.

10/18/1982 SUPPL-49 Labeling

Label is not available on this site.

10/18/1982 SUPPL-48 Efficacy

Label is not available on this site.

09/30/1983 SUPPL-47 Efficacy

Label is not available on this site.

02/08/1982 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1981 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

10/31/1986 SUPPL-44 Efficacy-New Indication

Label is not available on this site.

01/26/1982 SUPPL-43 Labeling

Label is not available on this site.

03/21/1983 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/19/1980 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1980 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1980 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1980 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/31/1986 SUPPL-35 Efficacy-New Indication

Label is not available on this site.

03/07/1979 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1979 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/12/1979 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1978 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/12/1978 SUPPL-29 Labeling

Label is not available on this site.

02/14/1978 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/24/1978 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1978 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1979 SUPPL-25 Efficacy

Label is not available on this site.

03/07/1979 SUPPL-24 Labeling

Label is not available on this site.

12/08/1977 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1977 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1976 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1978 SUPPL-20 Labeling

Label is not available on this site.

02/18/1975 SUPPL-16 Labeling

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-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf
09/06/2007 SUPPL-78 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf
08/18/2004 SUPPL-73 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16418s073lbl.pdf

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