Details for New Drug Application (NDA): 215238
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NDA 215238 describes IVABRADINE HYDROCHLORIDE, which is a drug marketed by Alembic, Annora Pharma, Bionpharma, Ingenus Pharms Llc, and Zydus Pharms, and is included in five NDAs. It is available from eight 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.
Summary for 215238
| Tradename: | IVABRADINE HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | ivabradine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215238
| Mechanism of Action | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists |
Suppliers and Packaging for NDA: 215238
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 215238 | ANDA | Alembic Pharmaceuticals Limited | 46708-679 | 46708-679-45 | 180 TABLET, FILM COATED in 1 BOTTLE (46708-679-45) |
| IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 215238 | ANDA | Alembic Pharmaceuticals Limited | 46708-679 | 46708-679-60 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-679-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Nov 8, 2024 | 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 8, 2024 | TE: | AB | RLD: | No | ||||
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