Details for New Drug Application (NDA): 206143
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NDA 206143 describes CORLANOR, which is a drug marketed by Amgen Inc and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the CORLANOR profile page.
The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.
The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.
Summary for 206143
| Tradename: | CORLANOR |
| Applicant: | Amgen Inc |
| Ingredient: | ivabradine hydrochloride |
| Patents: | 4 |
Pharmacology for NDA: 206143
| Mechanism of Action | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists |
Suppliers and Packaging for NDA: 206143
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143 | NDA | Amgen Inc | 55513-800 | 55513-800-60 | 60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60) |
| CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143 | NDA | Amgen Inc | 55513-800 | 55513-800-99 | 14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Apr 15, 2015 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 22, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 22, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 12, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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