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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078438
Company: AUROBINDO PHARMA

Other Important Information from FDA

Products on ANDA 078438

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078438

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
10/01/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/30/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/24/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/24/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/24/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/29/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/29/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/08/2009	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078438

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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