Felodipine

INFORMATION FOR PATIENTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

FELODIPINE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

Patients with Impaired Liver Function
CLINICAL PHARMACOLOGY

HOW SUPPLIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Felodipine Felodipine TABLET, EXTENDED RELEASE Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-191(NDC:53489-369) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELODIPINE FELODIPINE 5 mg Inactive Ingredients Ingredient Name Strength carnauba wax D&C YELLOW NO. 10 FD&C RED NO. 40 ALUMINUM OXIDE hydroxypropyl cellulose HYPROMELLOSES STARCH, CORN cellulose, microcrystalline polyethylene glycol polysorbate 80 povidone SILICON DIOXIDE titanium dioxide Product Characteristics Color Size Imprint Code Shape orange 12 mm MP;772 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-191-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075896 2011-04-20