Drugs@FDA: FDA-Approved Drugs
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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| INDERAL | PROPRANOLOL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| INDERAL | PROPRANOLOL HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| INDERAL | PROPRANOLOL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| INDERAL | PROPRANOLOL HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| INDERAL | PROPRANOLOL HYDROCHLORIDE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |