Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPOTEN | CAPTOPRIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOTEN | CAPTOPRIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOTEN | CAPTOPRIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOTEN | CAPTOPRIL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOTEN | CAPTOPRIL | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOTEN | CAPTOPRIL | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOTEN | CAPTOPRIL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/06/1981 | 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 |
|---|---|---|---|---|---|
| 08/01/2017 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018343s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018343Orig1s087ltr.pdf | |
| 06/19/2015 | SUPPL-86 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018343Orig1s086ltr.pdf | |
| 12/24/2014 | SUPPL-85 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018343s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018343Orig1s085ltr.pdf | |
| 08/27/2012 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018343Orig1s084ltr.pdf | |
| 12/14/2011 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s083ltr.pdf | |
| 05/19/2011 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s082ltr.pdf | |
| 09/25/2008 | SUPPL-81 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018343s081ltr.pdf |
| 05/07/2004 | SUPPL-75 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18343slr075ltr.pdf |
| 04/20/1999 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 01/09/1998 | SUPPL-72 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1997 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1996 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1996 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 03/06/1995 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-66 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 01/28/1994 | SUPPL-64 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 05/12/1993 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/25/1992 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 12/21/1992 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1992 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1995 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-56 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/07/1991 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1991 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/12/1991 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1990 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/21/1991 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 09/27/1990 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 05/10/1990 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1993 | SUPPL-48 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/03/1989 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/19/1989 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 05/13/1988 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/19/1988 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 06/26/1987 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/13/1988 | SUPPL-40 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/06/1987 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1987 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1986 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1990 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1986 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1986 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/18/1985 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1985 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/12/1984 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1985 | SUPPL-18 | Efficacy |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1984 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/08/1984 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/1984 | SUPPL-14 | Efficacy |
Label is not available on this site. |
||
| 10/14/1983 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/07/1984 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/14/1983 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/18/1983 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/07/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1982 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/1982 | SUPPL-5 | Efficacy |
Label is not available on this site. |
||
| 11/30/1981 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1981 | 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 |
|---|---|---|---|---|---|
| 08/01/2017 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018343s087lbl.pdf | |
| 06/19/2015 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf | |
| 12/24/2014 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018343s085lbl.pdf | |
| 08/27/2012 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf | |
| 12/14/2011 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s083lbl.pdf | |
| 05/19/2011 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s082lbl.pdf |