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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. 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 KIT profile page.

The generic ingredient in EPANED KIT is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

Summary for NDA: 204308

Tradename:
EPANED KIT
Applicant:
Silvergate Pharms
Ingredient:
enalapril maleate
Patents:2
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204308

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPANED KIT
enalapril maleate
FOR SOLUTION;ORAL 204308 NDA Silvergate Pharmaceuticals, Inc. 52652-1001 52652-1001-1 1 KIT in 1 CARTON (52652-1001-1) * 150 mL in 1 BOTTLE * 150 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength1MG/ML
Approval Date:Aug 13, 2013TE:RLD:Yes
Patent:8,568,747Patent Expiration:Nov 6, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:8,778,366Patent Expiration:Nov 6, 2032Product Flag?Substance Flag?Delist Request?
Patent:8,778,366Patent Expiration:Nov 6, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION


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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.

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