Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090096
Company: CHARTWELL RX

• Other Important Information from FDA

Products on ANDA 090096

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;15MG	TABLET;ORAL	Discontinued	None	No	No
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	25MG;15MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090096

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/13/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.