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
COMBIPATCH از شرکت NOVEN PHARMS INC
New Drug Application (NDA): 020870
Company: NOVEN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMBIPATCH | ESTRADIOL; NORETHINDRONE ACETATE | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription |
None |
Yes | No |
| COMBIPATCH | ESTRADIOL; NORETHINDRONE ACETATE | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 08/07/1998 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20870lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020870s023lbl.pdf |
||
| 06/08/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/2015 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020870s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020870Orig1s019ltr.pdf |
||
| 09/19/2013 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020870s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020870Orig1s017ltr.pdf |
||
| 11/16/2005 | SUPPL-15 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020870s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020870s015ltr.pdf |
||
| 01/13/2005 | SUPPL-13 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20870s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20870s013ltr.pdf |
||
| 06/18/2004 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20870slr010_CombiPatch_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20870slr010ltr.pdf |
||
| 02/12/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020870s023lbl.pdf | |
| 05/07/2015 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020870s019lbl.pdf | |
| 09/19/2013 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020870s017lbl.pdf | |
| 11/16/2005 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020870s015lbl.pdf | |
| 01/13/2005 | SUPPL-13 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20870s013lbl.pdf | |
| 06/18/2004 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20870slr010_CombiPatch_lbl.pdf | |
| 08/07/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20870lbl.pdf |
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