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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019888
Company: ALMATICA

Products on NDA 19888

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZESTORETIC	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	AB	Yes	No
ZESTORETIC	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	AB	Yes	No
ZESTORETIC	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 019888

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-69	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019888s069lbl.pdf
07/21/2017	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019888s067lbl.pdf
08/25/2015	SUPPL-65	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019888s065lbl.pdf
12/24/2014	SUPPL-56	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019888s056lbl.pdf
11/05/2013	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019888s055lbl.pdf
10/31/2012	SUPPL-53	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s053lbl.pdf
08/13/2012	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s054lbl.pdf
05/02/2012	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s051lbl.pdf
03/29/2012	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s052lbl.pdf
08/04/2011	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s050lbl.pdf
03/11/2011	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s049lbl.pdf
11/06/2009	SUPPL-47	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s047lbl.pdf
05/20/2009	SUPPL-45	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s045lbl.pdf

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