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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 two patents protecting this drug and one Paragraph IV challenge. 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-eight suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

Summary for NDA: 208686

Silvergate Pharms
enalapril maleate
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 208686

Suppliers and Packaging for NDA: 208686

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
enalapril maleate
SOLUTION;ORAL 208686 NDA Silvergate Pharmaceuticals, Inc. 52652-4001 52652-4001-1 150 mL in 1 BOTTLE (52652-4001-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 20, 2016TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.