Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022252
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NATAZIA DIENOGEST; ESTRADIOL VALERATE N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A 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
03/14/2012 ORIG-2 Approval Efficacy STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252Orig2s000ltr.pdf
05/06/2010 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022252s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022252s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/21/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022252s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022252Orig1s004ltr.pdf
08/22/2013 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022252s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022252Orig1s003ltr.pdf
02/13/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/21/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022252s004lbl.pdf
08/22/2013 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022252s003lbl.pdf
03/14/2012 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s002lbl.pdf
02/13/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf
05/06/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022252s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English