APPLICATION
ANDA075951
TYPE
ANDA
ORIGINAL APPROVAL
2001-05-25
LATEST ACTION
2006-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORETHINDRONE ACETATEPrescription
NORETHINDRONE ACETATE 5MG · TABLET · ORAL
Approval history
2006-05-31Labeling · Supplement 10AP
2005-04-12Labeling · Supplement 8AP
2004-10-14Labeling · Supplement 4AP
2001-11-26Manufacturing (CMC) · Supplement 1AP
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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