Application Nr Approved Date Route Status External Links
NDA021998 2009-07-10 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Plan B ® One-Step Is A Progestin-Only Emergency Contraceptive Indicated For Prevention Of Pregnancy Following Unprotected Intercourse Or A Known Or Suspected Contraceptive Failure. To Obtain Optimal Efficacy, The Tablet Should Be Taken As Soon As Possible Within 72 Hours Of Intercourse. Plan B One-Step Is Available Only By Prescription For Women Younger Than Age 17 Years, And Available Over The Counter For Women 17 Years And Older. Plan B One-Step Is Not Indicated For Routine Use As A Contraceptive. Plan B One-Step Is A Progestin-Only Emergency Contraceptive Indicated For Prevention Of Pregnancy Following Unprotected Intercourse Or A Known Or Suspected Contraceptive Failure. Plan B One-Step Is Available Only By Prescription For Women Younger Than Age 17 Years, And Available Over The Counter For Women 17 Years And Older. Plan B One-Step Is Not Intended For Routine Use As A Contraceptive. (1)

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Starch, Potato STARCH, POTATO Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levonorgestrel

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