Details for New Drug Application (NDA): 213442
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NDA 213442 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 213442
| Tradename: | IVABRADINE HYDROCHLORIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | ivabradine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213442
| Mechanism of Action | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists |
Suppliers and Packaging for NDA: 213442
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213442 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1471 | 70710-1471-6 | 60 TABLET in 1 BOTTLE (70710-1471-6) |
| IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213442 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1471 | 70710-1471-8 | 180 TABLET in 1 BOTTLE (70710-1471-8) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Nov 29, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 7.5MG BASE | ||||
| Approval Date: | Nov 29, 2023 | TE: | AB | RLD: | No | ||||
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