Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201524
Company: CHARTWELL RX

Products on ANDA 201524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET;ORAL	Discontinued	None	No	No
IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET;ORAL	Discontinued	None	No	No
IRBESARTAN; HYDROCHLOROTHIAZIDE	IRBESARTAN; HYDROCHLOROTHIAZIDE	300MG; 25MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2013	ORIG-2	Tentative Approval	Not Applicable			Label is not available on this site.
02/27/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/28/2025	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/10/2022	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
06/10/2022	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/10/2022	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/10/2022	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/13/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/13/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/27/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/12/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.