Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018998
Company: BAUSCH

• Other Important Information from FDA

Products on NDA 18998

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

Labels for NDA 018998

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2018	SUPPL-83	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018998s083lbl.pdf
07/21/2017	SUPPL-82	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018998s082lbl.pdf
08/25/2015	SUPPL-80	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018998s080lbl.pdf
12/24/2014	SUPPL-79	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018998s079lbl.pdf
09/13/2012	SUPPL-77	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf
02/17/2012	SUPPL-76	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s076lbl.pdf
09/25/2008	SUPPL-71	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf
11/27/2001	SUPPL-58	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf
02/13/2001	SUPPL-59	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_prntlbl.pdf