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
CYCLESSA از شرکت ASPEN GLOBAL INC
New Drug Application (NDA): 021090
Company: ASPEN GLOBAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLESSA | DESOGESTREL; ETHINYL ESTRADIOL | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | TABLET;ORAL-28 | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/20/2000 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-090_Cyclessa.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021090s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021090Orig1s008ltr.pdf |
||
| 09/10/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2007 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021090s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021090s004LTR.pdf |
||
| 02/24/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21090slr003ltr.pdf |
|
| 03/08/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/2001 | 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 |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-8 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021090s008lbl.pdf | |
| 08/09/2017 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021090s008lbl.pdf | |
| 03/26/2007 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021090s004lbl.pdf |
CYCLESSA
TABLET;ORAL-28; 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLESSA | DESOGESTREL; ETHINYL ESTRADIOL | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | TABLET;ORAL-28 | Prescription | Yes | AB | 021090 | ASPEN GLOBAL INC |
| DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | TABLET;ORAL-28 | Prescription | No | AB | 077182 | MAYNE PHARMA |
| VELIVET | DESOGESTREL; ETHINYL ESTRADIOL | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | TABLET;ORAL-28 | Prescription | No | AB | 076455 | DURAMED PHARMS BARR |
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