Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020125
Company: PFIZER PHARMS
Company: PFIZER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/28/1999 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20125ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20125_Accuretic.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/19/2021 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020125Irig1s028Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020125Orig1s028GAltr.pdf | |
| 08/20/2020 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020125s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020125Orig1s027ltr.pdf | |
| 05/05/2020 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020125Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020125Orig1s025ltr.pdf | |
| 04/26/2017 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020125s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020125Orig1s022ltr.pdf | |
| 06/06/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/2015 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s020lbl.pdf | |
| 02/05/2015 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020125Orig1s019ltr.pdf | |
| 05/02/2014 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020125Orig1s018ltr.pdf | |
| 10/25/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020125Orig1s017ltr.pdf | |
| 01/17/2014 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020125Orig1s016ltr_replacement.pdf | |
| 09/23/2013 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020125Orig1s015ltr.pdf | |
| 09/21/2012 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020125Orig1s014ltr.pdf | |
| 12/19/2012 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2012 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf | |
| 10/14/2011 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020125s011ltr.pdf | |
| 03/20/2011 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020125s010ltr.pdf | |
| 09/18/2009 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020125s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020125s007ltr.pdf | |
| 10/29/2003 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf |
| 01/28/2002 | 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 |
|---|---|---|---|---|---|
| 02/19/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020125Irig1s028Lbl.pdf | |
| 08/20/2020 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020125s027lbl.pdf | |
| 05/05/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020125Orig1s025lbl.pdf | |
| 05/05/2020 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020125Orig1s025lbl.pdf | |
| 04/26/2017 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020125s022lbl.pdf | |
| 09/11/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s020lbl.pdf | |
| 02/05/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s019lbl.pdf | |
| 05/02/2014 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf | |
| 01/17/2014 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s016lbl.pdf | |
| 10/25/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s017lbl.pdf | |
| 09/23/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s015lbl.pdf | |
| 09/21/2012 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s014lbl.pdf | |
| 01/18/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s012lbl.pdf | |
| 10/14/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s011lbl.pdf | |
| 03/20/2011 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf | |
| 09/18/2009 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020125s007lbl.pdf | |
| 12/28/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20125lbl.pdf |