Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022501
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LO LOESTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/29/2022 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf
04/29/2022 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf
10/15/2021 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022501s012lbl.pdf
10/10/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf
08/09/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf
10/21/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf

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