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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020130
Company: APIL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTROSTEP 21 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL-21 Discontinued None Yes No
ESTROSTEP FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL-28 Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/29/2022 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020130s022lbl.pdf
07/14/2021 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020130s021lbl.pdf
10/10/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s018lbl.pdf
08/09/2017 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s017lbl.pdf
07/01/2001 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf
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