Drugs@FDA: FDA-Approved Drugs
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PROPRANOLOL HYDROCHLORIDE | 25MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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PROPRANOLOL HYDROCHLORIDE | 25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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 |