Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021098
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
YASMIN | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
05/11/2001 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021098s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021098Orig1s030ltr.pdf | |
05/19/2023 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021098s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021098Orig1s029ltr.pdf | |
08/09/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021098s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021098Orig1s028ltr.pdf | |
03/08/2016 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/30/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/01/2015 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf | |
04/10/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021098Orig1s022.pdf | |
01/31/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/13/2012 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s019ltr.pdf | |
04/07/2010 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021098s017ltr.pdf | |
08/08/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/2003 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21098se8-005ltr.pdf | |
12/12/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/30/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/30/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/26/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/19/2023 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021098s029lbl.pdf | |
04/29/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021098s030lbl.pdf | |
08/09/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021098s028lbl.pdf | |
06/01/2015 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf | |
04/10/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf | |
02/13/2012 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf | |
04/07/2010 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf | |
05/09/2003 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf | |
05/11/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf |
YASMIN
TABLET;ORAL-28; 3MG;0.03MG
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;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 090081 | DR REDDYS LABS SA |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 204848 | GLENMARK PHARMS LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 213034 | HETERO LABS |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 201663 | LUPIN LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 207245 | NAARI PTE LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 202131 | XIROMED |
SYEDA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 090114 | XIROMED |
YAELA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 202015 | NOVAST LABS |
YASMIN | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | Yes | AB | 021098 | BAYER HLTHCARE |
ZUMANDIMINE | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | Prescription | No | AB | 209407 | AUROBINDO PHARMA LTD |