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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

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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