Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020870
Company: NOVEN PHARMS INC
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 | Yes |
| COMBIPATCH | ESTRADIOL; NORETHINDRONE ACETATE | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020870s033lbl.pdf | |
| 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 |