Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019885
Company: PFIZER PHARMS
Company: PFIZER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 05/18/2020 | SUPPL-45 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019885Orig1s045ltr.pdf |
| 04/26/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s043ltr.pdf | |
| 02/13/2017 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s042ltr.pdf | |
| 09/11/2015 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019885Orig1s041ltr.pdf | |
| 05/02/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019885Orig1s040ltr.pdf | |
| 10/25/2013 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s039ltr.pdf | |
| 09/23/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s038ltr.pdf | |
| 04/09/2013 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s037ltr.pdf | |
| 09/21/2012 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf | |
| 01/18/2012 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf | |
| 10/14/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019885s033ltr.pdf | |
| 09/18/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019885s028ltr.pdf | |
| 10/29/2003 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf |
| 12/13/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/21/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/22/2002 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19885slr019ltr.pdf |
| 04/17/2001 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19885S18ltr.pdf |
| 09/10/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/03/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/18/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/26/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/12/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/29/1993 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/26/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s043lbl.pdf | |
| 02/13/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s042lbl.pdf | |
| 09/11/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf | |
| 05/02/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf | |
| 10/25/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf | |
| 09/23/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf | |
| 04/09/2013 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf | |
| 09/21/2012 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf | |
| 01/18/2012 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf | |
| 10/14/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf | |
| 09/18/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf |