Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204654
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LO MINASTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG,N/A;1MG,N/A,N/A TABLET, CHEWABLE, TABLET;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
07/24/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204654s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204654Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204654Orig1s008ltr.pdf
06/28/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204654Orig1s006ltr.pdf
10/07/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/20/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/16/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s008lbl.pdf
06/28/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s006lbl.pdf
07/24/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204654s000lbl.pdf

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