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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075496
Company: SANDOZ INC

Products on ANDA 075496

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075496

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75459ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/18/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/17/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/01/2002	SUPPL-3	Labeling		Label is not available on this site.
04/24/2002	SUPPL-2	Labeling		Label is not available on this site.
09/10/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075496

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	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	075657	TARO
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Prescription	No	AB	075483	WOCKHARDT LTD
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	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	075657	TARO
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	075483	WOCKHARDT LTD
VASOTEC	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Prescription	Yes	AB	018998	BAUSCH

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