Drugs@FDA: FDA Approved Drug Products

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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 Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20870lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20870ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20870_CombiPatch.cfm
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 Label (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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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