Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203505
Company: DUCHESNAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSPHENA OSPEMIFENE 60MG 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
02/26/2013 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203505s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203505Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203505Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203505s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203505Orig1s015ltr.pdf
10/26/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203505s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203505Orig1s014ltr.pdf
03/17/2017 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/24/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/24/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/24/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/20/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/23/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/25/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203505s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203505Orig1s005ltr.pdf
05/02/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/08/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/13/2013 SUPPL-1 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
01/25/2019 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203505s015lbl.pdf
10/26/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203505s014lbl.pdf
02/25/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203505s005lbl.pdf
02/26/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203505s000lbl.pdf

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