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Plan B One-Step Approval History

  • FDA approved: Yes (First approved July 10th, 2009)
  • Brand name: Plan B One-Step
  • Generic name: levonorgestrel
  • Dosage form: Tablet
  • Company: Teva Pharmaceuticals, Inc.
  • Treatment for: Emergency Contraception

Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure.

Development History and FDA Approval Process for Plan B One-Step

Jun 20, 2013Approval FDA Approves Plan B One-Step Emergency Contraceptive For Use Without A Prescription For All Women Of Child-Bearing Potential
Apr 30, 2013Approval FDA Approves Plan B One-Step Emergency Contraceptive Without a Prescription for Women 15 Years of Age and Older
Jul 13, 2009Approval FDA Approves Plan B One-Step, a New One-Pill Emergency Contraceptive

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