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Details for New Drug Application (NDA): 204308
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The generic ingredient in EPANED KIT is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty 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
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 |
Paragraph IV (Patent) Challenges for 204308
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
EPANED KIT | FOR SOLUTION;ORAL | enalapril maleate | 204308 | 2016-06-21 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Aug 13, 2013 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Nov 6, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Nov 6, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING HYPERTENSION | ||||||||
Patent: | Start Trial | Patent Expiration: | Nov 6, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION |
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