Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021676
Company: BAYER HLTHCARE
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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021676s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021676Orig1s021ltr.pdf | |
05/19/2023 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021676s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021676Orig1s020ltr.pdf | |
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 |
---|---|---|---|---|---|
05/19/2023 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021676s020lbl.pdf | |
04/29/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021676s021lbl.pdf | |
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 | 204296 | GLENMARK PHARMS LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 211944 | HETERO LABS |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 203291 | HLTHCARE |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 078833 | WATSON LABS |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 202594 | XIROMED |
LO-ZUMANDIMINE | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 209632 | AUROBINDO PHARMA LTD |
LORYNA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 079221 | XIROMED |
MELAMISA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 202016 | NOVAST LABS |
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 |