APPLICATION
ANDA091209
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-22
LATEST ACTION
2023-05-24
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORETHINDRONEPrescription
NORETHINDRONE 0.35MG · TABLET · ORAL-28
Approval history
2023-05-24Labeling · Supplement 10 · standardAP
2015-05-14Labeling · Supplement 5 · standardAP
2013-03-29Labeling · Supplement 3 · standardAP
2012-07-31Labeling · Supplement 2AP
2010-07-22OriginalAP
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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