Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204426
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAYTULLA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/19/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204426s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204426Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426_minastrin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204426s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204426Orig1s007ltr.pdf
08/19/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204426s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204426Orig1s004ltr.pdf
07/22/2015 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204426s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204426s007lbl.pdf
08/19/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204426s004lbl.pdf
07/22/2015 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204426s001lbl.pdf
04/19/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204426s000lbl.pdf

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