Details for New Drug Application (NDA): 214051
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NDA 214051 describes IVABRADINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Bionpharma, Ingenus Pharms Llc, and Zydus Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the IVABRADINE HYDROCHLORIDE profile page.
The generic ingredient in IVABRADINE HYDROCHLORIDE 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 IVABRADINE HYDROCHLORIDE 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 214051
| Tradename: | IVABRADINE HYDROCHLORIDE |
| Applicant: | Ingenus Pharms Llc |
| Ingredient: | ivabradine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 214051
| Mechanism of Action | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists |
Suppliers and Packaging for NDA: 214051
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 214051 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-362 | 50742-362-60 | 60 TABLET, FILM COATED in 1 BOTTLE (50742-362-60) |
| IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 214051 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-363 | 50742-363-60 | 60 TABLET, FILM COATED in 1 BOTTLE (50742-363-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Dec 30, 2021 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jan 11, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 7.5MG BASE | ||||
| Approval Date: | Dec 30, 2021 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jan 11, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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