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 |
| 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 |