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FDA NDA · NDA022574

SAFYRAL

drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium

Sponsor: BAYER HLTHCARE

APPLICATION
NDA022574
TYPE
NDA
ORIGINAL APPROVAL
2010-12-16
LATEST ACTION
2023-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SAFYRAL · ReferencePrescription
DROSPIRENONE 3MG,N/A, ETHINYL ESTRADIOL 0.03MG,N/A, LEVOMEFOLATE CALCIUM 0.451MG,0.451MG · TABLET · ORAL

Approval history

2023-05-19Labeling · Supplement 10 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 11 · standard — Label ↗AP
2017-08-09Labeling · Supplement 9 · standard — Label ↗AP
2015-06-01Labeling · Supplement 6 · standard — Letter ↗AP
2012-04-10Labeling · Supplement 4 · standard — Review ↗AP
2012-02-13Efficacy · Supplement 1 · standard — Letter ↗AP
2010-12-16Type 5 - New Formulation or New Manufacturer · 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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