Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020683
Company: CADENCE HEALTH
Company: CADENCE HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | Yes | No |
| ALESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/16/2024 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020683s014lbl.pdf | |
| 04/29/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020683s016lbl.pdf | |
| 03/20/2018 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020683s012lbl.pdf | |
| 08/09/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020683s011lbl.pdf | |
| 01/31/2008 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf | |
| 01/31/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf | |
| 01/31/2008 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf |