Details for New Drug Application (NDA): 204308
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NDA 204308 describes EPANED KIT, which is a drug marketed by Azurity and is included in one NDA. There are four 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-five suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
The generic ingredient in EPANED KIT 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 204308
| Tradename: | EPANED KIT |
| Applicant: | Azurity |
| Ingredient: | enalapril maleate |
| Patents: | 4 |
Medical Subject Heading (MeSH) Categories for 204308
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 13, 2013 | TE: | RLD: | Yes | |||||
| Patent: | 8,568,747 | Patent Expiration: | Nov 6, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,778,366 | Patent Expiration: | Nov 6, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING HYPERTENSION | ||||||||
| Patent: | 8,778,366 | Patent Expiration: | Nov 6, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION | ||||||||
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