Active Ingredient: ETHINYL ESTRADIOL; LEVONORGESTREL
Proprietary Name: BALCOLTRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.02MG;0.1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB3
Application Number: N208612
Product Number: 001
Approval Date: Jan 9, 2018
Applicant Holder Full Name: AVION PHARMACEUTICALS LLC
Marketing Status:
Prescription
Patent and Exclusivity Information