APPLICATION
ANDA091325
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-19
LATEST ACTION
2020-04-28
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORETHINDRONEPrescription
NORETHINDRONE 0.35MG · TABLET · ORAL-28
Approval history
2020-04-28Manufacturing (CMC) · Supplement 8AP
2012-12-28Labeling · Supplement 2 · standardAP
2011-09-19OriginalAP
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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