Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020071
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESOGEN | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| DESOGEN | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/15/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020071s023lbl.pdf | |
| 08/09/2017 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020071s025lbl.pdf | |
| 06/07/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf |