Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021355
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANGELIQ DROSPIRENONE; ESTRADIOL 0.25MG;0.5MG TABLET;ORAL Prescription None Yes No
ANGELIQ DROSPIRENONE; ESTRADIOL 0.5MG;1MG 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
09/28/2005 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021355ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021355s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021355s008lbl.pdf
06/30/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021355Orig1s006ltr.pdf
01/26/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/29/2012 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s003ltr.pdf
02/29/2012 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021355s008lbl.pdf
06/30/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf
02/29/2012 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf
02/29/2012 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf
09/28/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf

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