Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076486
Company: NOSTRUM LABS INC

Products on ANDA 076486

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET;ORAL	Discontinued	None	No	No
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076486

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2004	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
07/06/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/29/2009	SUPPL-8	Labeling		Label is not available on this site.
02/06/2007	SUPPL-3	Labeling		Label is not available on this site.