اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ALESSE از شرکت CADENCE HEALTH
New Drug Application (NDA): 020683
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ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL-21 | Discontinued |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ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL-28 | Discontinued |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 |
|
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 |
|---|---|---|---|---|---|
| 03/20/2018 | SUPPL-12 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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 |
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