Details for New Drug Application (NDA): 214439
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NDA 214439 describes NORLIQVA, which is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the NORLIQVA profile page.
The generic ingredient in NORLIQVA is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.
The generic ingredient in NORLIQVA is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.
Summary for 214439
| Tradename: | NORLIQVA |
| Applicant: | Cmp Dev Llc |
| Ingredient: | amlodipine besylate |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214439
| Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 214439
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORLIQVA | amlodipine besylate | SOLUTION;ORAL | 214439 | NDA | CMP Pharma, Inc. | 46287-035 | 46287-035-15 | 150 mL in 1 BOTTLE (46287-035-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Feb 24, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 24, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | NORLIQVA IS INDICATED FOR THE SYMPTOMATIC TREATMENT OF CHRONIC STABLE ANGINA | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 24, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | NORLIQVA IS INDICATED FOR THE TREATMENT OF CONFIRMED OR SUSPECTED VASOSPASTIC ANGINA | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 24, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | NORLIQVA IS INDICATED FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER | ||||||||
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