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Setid 2aad9cdf 6431 4661 5cb4 F69e735f47e4 Applno 19834 Form Tablet Extended Release Oral Dosage 2 5mg - Drug Product Composition: Felodipine

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$ API Ref.Price (USD/KG) : 387Xls

USFDA APPLICATION NUMBER - 19834 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELODIPINE(UNII: OL961R6O2C)
(FELODIPINE - UNII:OL961R6O2C)
FELODIPINE10mg | 5mg | 2.5mg

Inactive Ingredients

Ingredient Name
AstraZeneca Pharmaceuticals LP
Bryant Ranch Prepack
ALCOHOL(3K9958V90M)
ALUMINUM SILICATE(T1FAD4SS2M)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSES(3NXW29V3WO)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POVIDONES(FZ989GH94E)
PROPYL GALLATE(8D4SNN7V92)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TITANIUM DIOXIDE(15FIX9V2JP)