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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 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. Twenty-eight 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. Twenty-eight 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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