An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/30/2010	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		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

Top