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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 204308


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NDA 204308 describes EPANED KIT, which is a drug marketed by Silvergate Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EPANED KIT profile page.

The generic ingredient in EPANED KIT is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
Summary for 204308
Tradename:EPANED KIT
Applicant:Silvergate Pharms
Ingredient:enalapril maleate
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 204308

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 13, 2013TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 6, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Nov 6, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION
Patent:⤷  Try a TrialPatent Expiration:Nov 6, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION

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