MedPath
FDA Product

FELODIPINE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

FELODIPINE

55648-414

Regulatory Information

55648-414

ANDA091484

C73584

September 9, 2010

USA

Felodipine Extended-Release Tablets, USP Rx only

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

WOCKHARDT LIMITED

650069115

Active Ingredients

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

FELODIPINE

Quantity: 10 mg in 1 1

Code: OL961R6O2C

Class Code: ACTIB

POLYOXYL 40 HYDROGENATED CASTOR OIL

Code: 7YC686GQ8F

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

HYDROXYPROPYL CELLULOSE

Code: RFW2ET671P

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

FELODIPINE

Code: OL961R6O2C

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