Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021676
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YAZ DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription AB 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
03/16/2006 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021676s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021676s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021676s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021676s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021676Orig1s019ltr.pdf
07/31/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/04/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/01/2015 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021676s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf
01/31/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/10/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021676Orig1s012.pdf
04/07/2010 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021676s009ltr.pdf
03/11/2011 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021676s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021676s008ltr.pdf
01/26/2007 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021676s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021676s019lbl.pdf
06/01/2015 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021676s014lbl.pdf
04/10/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf
03/11/2011 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021676s008lbl.pdf
04/07/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf
03/16/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021676s000lbl.pdf

YAZ

TABLET;ORAL; 3MG;0.02MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 078515 BARR
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 204296 GLENMARK PHARMS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 202594 MYLAN LABS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 203291 PII
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 078833 WATSON LABS
LORYNA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 079221 SANDOZ
MELAMISA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 202016 NOVAST LABS LTD
NIKKI DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 201661 LUPIN LTD
YAZ DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription Yes AB 021676 BAYER HLTHCARE

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