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FDA NDA · NDA021258

CLIMARA PRO

estradiol and levonorgestrel

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021258
TYPE
NDA
ORIGINAL APPROVAL
2003-11-21
LATEST ACTION
2024-02-15
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CLIMARA PRO · ReferencePrescription
ESTRADIOL 0.045MG/24HR, LEVONORGESTREL 0.015MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2024-02-15Labeling · Supplement 15 · standard — Label ↗AP
2021-11-15Labeling · Supplement 12 · standard — Letter ↗AP
2021-10-07Labeling · Supplement 13 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 11 · standard — Label ↗AP
2016-03-08Manufacturing (CMC) · Supplement 10 · standardAP
2013-10-09Labeling · Supplement 6 · standard — Letter ↗AP
2005-06-22Labeling · Supplement 3 · standard — Letter ↗AP
2003-11-21Type 4 - New Combination · Original · standard — Letter ↗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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