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  • Ivabradine IVABRADINE HYDROCHLORIDE 7.5 mg/1 Zydus Lifesciences Limited
FDA Drug information

Ivabradine

Read time: 1 mins
Marketing start date: 04 Apr 2025
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Summary of product characteristics


Effective Time

20241130

Version

2

Spl Product Data Elements

ivabradine ivabradine IVABRADINE HYDROCHLORIDE IVABRADINE ALUMINUM OXIDE ANHYDROUS LACTOSE D&C RED NO. 27 ALUMINUM LAKE D&C YELLOW NO. 10 FERRIC OXIDE RED HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE 1471 ivabradine ivabradine IVABRADINE HYDROCHLORIDE IVABRADINE ALUMINUM OXIDE ANHYDROUS LACTOSE D&C RED NO. 27 ALUMINUM LAKE D&C YELLOW NO. 10 FERRIC OXIDE RED HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE 1472

Application Number

ANDA213442

Brand Name

Ivabradine

Generic Name

ivabradine

Product Ndc

70771-1864

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Ivabradine Tablets, 5 mg NDC 70771-1863-6 60 tablets Rx only Ivabradine Tablets, 5 mg NDC 70771-1864-6 60 tablets Rx only 5 mg 7.5 mg

Spl Medguide

SPL MEDGUIDE

Drug section

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