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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020125
Company: PFIZER PHARMS

Products on NDA 020125

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACCURETIC	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ACCURETIC	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ACCURETIC	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020125

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-Container/Carton Labels, Labeling-Package Insert	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.

Labels for NDA 020125

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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020125Orig1s025lbl.pdf
05/05/2020	SUPPL-25	Labeling-Package Insert	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

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