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): 075657
Company: TARO

Products on ANDA 075657

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	AB	No	No
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	AB	No	No
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75657ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
08/07/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/25/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/25/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/28/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/24/2008	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075657

ENALAPRIL MALEATE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	075178	AIPING PHARM INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	075479	HERITAGE PHARMA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	213273	PRINSTON INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	075496	SANDOZ INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	075483	SENORES PHARMS
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	075657	TARO
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	218531	UNIQUE PHARM
VASOTEC	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	Yes	AB	018998	BAUSCH

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	075178	AIPING PHARM INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	075479	HERITAGE PHARMA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	213273	PRINSTON INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	075496	SANDOZ INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	075483	SENORES PHARMS
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	075657	TARO
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	218531	UNIQUE PHARM
VASOTEC	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	Yes	AB	018998	BAUSCH

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	075178	AIPING PHARM INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	075479	HERITAGE PHARMA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	213273	PRINSTON INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	075459	SANDOZ INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	075483	SENORES PHARMS
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	075657	TARO
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	218531	UNIQUE PHARM
VASOTEC	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Prescription	Yes	AB	018998	BAUSCH

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	075178	AIPING PHARM INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	075479	HERITAGE PHARMA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	213273	PRINSTON INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	075459	SANDOZ INC
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	075483	SENORES PHARMS
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	075657	TARO
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	218531	UNIQUE PHARM
VASOTEC	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Prescription	Yes	AB	018998	BAUSCH

Top