Details for New Drug Application (NDA): 208401
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NDA 208401 describes QBRELIS, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the QBRELIS profile page.
The generic ingredient in QBRELIS is lisinopril. There are twenty-one drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lisinopril profile page.
The generic ingredient in QBRELIS is lisinopril. There are twenty-one drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lisinopril profile page.
Summary for 208401
| Tradename: | QBRELIS |
| Applicant: | Azurity |
| Ingredient: | lisinopril |
| Patents: | 9 |
Pharmacology for NDA: 208401
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 208401
Suppliers and Packaging for NDA: 208401
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QBRELIS | lisinopril | SOLUTION;ORAL | 208401 | NDA | Azurity Pharmaceuticals, Inc. | 52652-3001 | 52652-3001-1 | 150 mL in 1 BOTTLE (52652-3001-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Jul 29, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 6, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ACUTE MYOCARDIAL INFARCTION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 6, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING HYPERTENSION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 6, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATMENT OF HEART FAILURE | ||||||||
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