www.fdanews.com/articles/86728-watson-receives-tentative-approval-for-generic-seasonale
WATSON RECEIVES TENTATIVE APPROVAL FOR GENERIC SEASONALE
May 10, 2006
Watson Pharmaceuticals has received tentative approval today from the FDA on its abbreviated new drug application (ANDA) for levonorgestrel / ethinyl estradiol tablets USP, in 0.15 mg and 0.03 mg.
Levonorgestrel / ethinyl estradiol tablets USP is the generic equivalent to Duramed Pharmaceuticals' Seasonale tablets, which is indicated for prevention of pregnancy.