Duramed's ANDA 75-809, approved July 16, contains levonorgestrel and ethinyl estradiol (1"The Pink Sheet" July 23, p. 8)
You may also be interested in...
FDA's ANDA Approvals
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials