APPLICATION
ANDA071546
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-09
LATEST ACTION
1993-10-18
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORCEPT-E 1/35 28Discontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
1993-10-18Labeling · Supplement 4AP
1989-04-26Manufacturing (CMC) · Supplement 1AP
1989-02-09OriginalAP
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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