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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077522
Company: LUPIN

Other Important Information from FDA

Products on ANDA 077522

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRANDOLAPRIL	TRANDOLAPRIL	1MG	TABLET;ORAL	Prescription	AB	No	No
TRANDOLAPRIL	TRANDOLAPRIL	2MG	TABLET;ORAL	Prescription	AB	No	No
TRANDOLAPRIL	TRANDOLAPRIL	4MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077522

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
08/26/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
07/21/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/21/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/21/2015	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/30/2010	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/15/2009	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077522

TRANDOLAPRIL

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRANDOLAPRIL	TRANDOLAPRIL	1MG	TABLET;ORAL	Prescription	No	AB	078438	AUROBINDO PHARMA
TRANDOLAPRIL	TRANDOLAPRIL	1MG	TABLET;ORAL	Prescription	No	AB	078508	EPIC PHARMA
TRANDOLAPRIL	TRANDOLAPRIL	1MG	TABLET;ORAL	Prescription	No	AB	077522	LUPIN

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRANDOLAPRIL	TRANDOLAPRIL	2MG	TABLET;ORAL	Prescription	No	AB	078438	AUROBINDO PHARMA
TRANDOLAPRIL	TRANDOLAPRIL	2MG	TABLET;ORAL	Prescription	No	AB	078508	EPIC PHARMA
TRANDOLAPRIL	TRANDOLAPRIL	2MG	TABLET;ORAL	Prescription	No	AB	077522	LUPIN

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRANDOLAPRIL	TRANDOLAPRIL	4MG	TABLET;ORAL	Prescription	No	AB	078438	AUROBINDO PHARMA
TRANDOLAPRIL	TRANDOLAPRIL	4MG	TABLET;ORAL	Prescription	No	AB	078508	EPIC PHARMA
TRANDOLAPRIL	TRANDOLAPRIL	4MG	TABLET;ORAL	Prescription	No	AB	077522	LUPIN

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