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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012616
Company: PFIZER

Products on NDA 012616

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	AB	Yes	No
ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	50MG;50MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012616

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/1961	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
11/14/2025	SUPPL-85	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012616s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/012616Orig1s085ltr.pdf
12/19/2022	SUPPL-83	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012616s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/012616Orig1s083ltr.pdf
02/19/2021	SUPPL-81	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012616s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/012616Orig1s081ltr.pdf
08/20/2020	SUPPL-80	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012616s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012616Orig1s080ltr.pdf
01/17/2019	SUPPL-78	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012616s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/012616Orig1s078ltr.pdf
10/22/2014	SUPPL-76	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf
03/06/2014	SUPPL-75	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s075ltr.pdf
01/17/2014	SUPPL-74	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s074ltr.pdf
06/12/2013	SUPPL-73	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012616Orig1s073ltr.pdf
06/14/2013	SUPPL-72	Manufacturing (CMC)		Label is not available on this site.
09/22/2011	SUPPL-69	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s069ltr.pdf
05/19/2011	SUPPL-68	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s068ltr.pdf
11/26/2002	SUPPL-63	Manufacturing (CMC)-Control		Label is not available on this site.
04/21/1999	SUPPL-62	Labeling		Label is not available on this site.
01/13/1999	SUPPL-61	Labeling		Label is not available on this site.
11/13/1997	SUPPL-58	Labeling		Label is not available on this site.
01/23/1990	SUPPL-55	Manufacturing (CMC)		Label is not available on this site.
11/13/1997	SUPPL-37	Labeling		Label is not available on this site.
01/04/1978	SUPPL-16	Unspecified		Label is not available on this site.

Labels for NDA 012616

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2025	SUPPL-85	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012616s085lbl.pdf
12/19/2022	SUPPL-83	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012616s083lbl.pdf
02/19/2021	SUPPL-81	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012616s081lbl.pdf
08/20/2020	SUPPL-80	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012616s080lbl.pdf
01/17/2019	SUPPL-78	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012616s078lbl.pdf
10/22/2014	SUPPL-76	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf
03/06/2014	SUPPL-75	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf
01/17/2014	SUPPL-74	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf
06/12/2013	SUPPL-73	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf
05/19/2011	SUPPL-68	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf

Therapeutic Equivalents for NDA 012616

ALDACTAZIDE

TABLET;ORAL; 25MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	Yes	AB	012616	PFIZER
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	No	AB	086513	MYLAN
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	No	AB	089534	SUN PHARM INDUSTRIES

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