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Generated: January 18, 2019

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Details for New Drug Application (NDA): 208686

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NDA 208686 describes EPANED, which is a drug marketed by Silvergate Pharms and is included in two NDAs. It is available from one supplier. There are seven 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. Forty suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
Summary for 208686
Tradename:EPANED
Applicant:Silvergate Pharms
Ingredient:enalapril maleate
Patents:3
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 Silvergate Pharmaceuticals, Inc. 52652-4001 52652-4001-1 150 mL in 1 BOTTLE (52652-4001-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 20, 2016TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 25, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 25, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 25, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION

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Serving hundreds of leading biopharmaceutical companies globally:

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