Original New Drug Application Approvals by US FDA (1 - 15 January 2018)
New drug applications approved by US FDA as of 1-15 January 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
LEVONORGESTREL; ETHINYL ESTRADIOL; FERROUS
- Active Ingredient(s): Levonorgesterel; Ethinyl Estradiol; Ferrous
- Strength: 0.1mg;0.02mg;36.5mg
- Dosage Form: Tablet; oral
- Company: Neuvosyn Laboratories LLC
- Approval Date: January 09, 2018
- Submission Classification: Not available
- Indication(s): Indicated for use by females of reproductive potential to prevent pregnancy.
- Approved Label: 01/09/2018(PDF)