Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022532
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BEYAZ DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/24/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022532s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022532s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022532_beyaz_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022532Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022532s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022532Orig1s009ltr.pdf
05/11/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/01/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf
04/10/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s004.pdf
02/13/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022532s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022532s009lbl.pdf
06/01/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf
04/10/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf
02/13/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf
09/24/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022532s000lbl.pdf

BEYAZ

TABLET;ORAL; 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BEYAZ DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 022532 BAYER HLTHCARE
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 203593 WATSON LABS INC

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