← FDA DRUG APPROVALS

FDA NDA · NDA020870

COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)

estradiol/norethindrone acetate transdermal system

Sponsor: NOVEN PHARMS INC

APPLICATION
NDA020870
TYPE
NDA
ORIGINAL APPROVAL
1998-08-07
LATEST ACTION
2024-02-15
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

COMBIPATCH · ReferencePrescription
ESTRADIOL 0.05MG/24HR, NORETHINDRONE ACETATE 0.14MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
COMBIPATCH · ReferencePrescription
ESTRADIOL 0.05MG/24HR, NORETHINDRONE ACETATE 0.25MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2024-02-15Labeling · Supplement 33 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 23 · standard — Label ↗AP
2015-06-08Manufacturing (CMC) · Supplement 20 · standardAP
2015-05-07Labeling · Supplement 19 · standard — Letter ↗AP
2013-09-19Labeling · Supplement 17 · unknown — Letter ↗AP
2005-11-16Labeling · Supplement 15 · standard — Label ↗AP
2005-01-13Labeling · Supplement 13 · standard — Label ↗AP
2004-06-18Labeling · Supplement 10 · standard — Letter ↗AP
2002-04-01Manufacturing (CMC) · Supplement 7 · standardAP
2002-02-12Manufacturing (CMC) · Supplement 8 · standardAP
2001-03-15Manufacturing (CMC) · Supplement 5 · standardAP
2000-05-04Manufacturing (CMC) · Supplement 4 · standardAP
2000-04-19Manufacturing (CMC) · Supplement 3 · standardAP
2000-02-04Manufacturing (CMC) · Supplement 2 · standardAP
1999-11-29Manufacturing (CMC) · Supplement 1 · standardAP
1998-08-07Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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