APPLICATION
ANDA091323
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-28
LATEST ACTION
2023-05-30
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
JENCYCLAPrescription
NORETHINDRONE 0.35MG · TABLET · ORAL-28
Approval history
2023-05-30Labeling · Supplement 8 · standardAP
2020-01-22Manufacturing (CMC) · Supplement 6AP
2015-04-02Labeling · Supplement 2 · standardAP
2013-03-28Not Applicable · OriginalAP
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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