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ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | Yes | No |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ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/27/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020683_alesse_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020683s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020683Orig1s016ltr.pdf | |
03/20/2018 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020683s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020683Orig1s012ltr.pdf | |
08/09/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020683s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020683Orig1s011ltr.pdf | |
01/31/2008 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s007ltr.pdf | |
01/31/2008 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s006ltr.pdf | |
03/06/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/31/2008 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s004ltr.pdf | |
02/12/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |