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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 208686


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NDA 208686 describes EPANED, which is a drug marketed by Azurity and Silvergate Pharms and is included in two NDAs. It is available from two suppliers. There are thirteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the EPANED profile page.

The generic ingredient in EPANED 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 208686
Tradename:EPANED
Applicant:Azurity
Ingredient:enalapril maleate
Patents:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 208686
Medical Subject Heading (MeSH) Categories for 208686
Suppliers and Packaging for NDA: 208686
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPANED enalapril maleate SOLUTION;ORAL 208686 NDA Azurity Pharmaceuticals, Inc. 52652-4001 52652-4001-1 150 mL in 1 BOTTLE (52652-4001-1)
EPANED enalapril maleate SOLUTION;ORAL 208686 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals NY LLC 69238-2141 69238-2141-7 1 BOTTLE in 1 CARTON (69238-2141-7) / 150 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 20, 2016TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 25, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Mar 25, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION
Patent:⤷  Try a TrialPatent Expiration:Mar 25, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION

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