Details for New Drug Application (NDA): 208686
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NDA 208686 describes EPANED, which is a drug marketed by Azurity and is included in two NDAs. It is available from three suppliers. There are thirteen patents protecting this drug and two Paragraph IV challenges. 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-four suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
The generic ingredient in EPANED is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
Summary for 208686
| Tradename: | EPANED |
| Applicant: | Azurity |
| Ingredient: | enalapril maleate |
| Patents: | 9 |
Pharmacology for NDA: 208686
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 208686
Suppliers and Packaging for NDA: 208686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPANED | enalapril maleate | SOLUTION;ORAL | 208686 | NDA | Wilshire Pharmaceuticals, Inc. | 52536-401 | 52536-401-01 | 1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE |
| EPANED | enalapril maleate | SOLUTION;ORAL | 208686 | NDA | Azurity Pharmaceuticals, Inc. | 52652-4001 | 52652-4001-1 | 150 mL in 1 BOTTLE (52652-4001-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Sep 20, 2016 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,039,745 | Patent Expiration: | Mar 25, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,154,987 | Patent Expiration: | Mar 25, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING HYPERTENSION | ||||||||
| Patent: | 10,154,987 | Patent Expiration: | Mar 25, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION | ||||||||
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