Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077805
Company: WATSON LABS

• Other Important Information from FDA

Products on ANDA 077805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRANDOLAPRIL	TRANDOLAPRIL	1MG	TABLET;ORAL	Discontinued	None	No	No
TRANDOLAPRIL	TRANDOLAPRIL	2MG	TABLET;ORAL	Discontinued	None	No	No
TRANDOLAPRIL	TRANDOLAPRIL	4MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2007	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
06/22/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/22/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/29/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.