Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078346
Company: MYLAN

• Other Important Information from FDA

Products on ANDA 078346

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 078346

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2008	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
04/14/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/31/2010	SUPPL-2	Labeling		Label is not available on this site.