Climara Pro

Product Category

US FDA-Approved Medicine

Formulation

ESTRADIOL: 0.045 mg/day LEVONORGESTREL 0.015 mg/day Film, Extended Release, Transdermal; Apply once-weekly to lower abdomen Each 22 cm^2 system contains 4.4 mg estradiol and 1.39 mg levonorgestrel. System comprises three layers: (1) a translucent polyethylene backing film (2) an acrylate adhesive matrix containing estradiol and levonorgestrel (acrylate copolymer adhesive and polyvinylpyrrolidone/vinylacetate copolymer) (3) A protective layer of either siliconized or fluoropolymer coated polyester film. The protective liner is attached to the adhesive surface and must be removed before the system can be used.

Status

Prescription

ANDA #

021258 (Bayer), 021885 (Berlex)