Details for New Drug Application (NDA): 213366
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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 213366
Tradename: | IVABRADINE HYDROCHLORIDE |
Applicant: | Annora Pharma |
Ingredient: | ivabradine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213366
Mechanism of Action | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists |
Suppliers and Packaging for NDA: 213366
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213366 | ANDA | Camber Pharmaceuticals, Inc. | 31722-053 | 31722-053-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-053-60) |
IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213366 | ANDA | Camber Pharmaceuticals, Inc. | 31722-054 | 31722-054-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-054-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Oct 5, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 7.5MG BASE | ||||
Approval Date: | Oct 5, 2022 | TE: | AB | RLD: | No |
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