APPLICATION
NDA017948
TYPE
NDA
ORIGINAL APPROVAL
1978-02-21
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORMINEST FEPrescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.5MG, FERROUS FUMARATE 75MG · TABLET · ORAL
Approval history
1995-06-02Labeling · Supplement 43 · standardAP
1992-07-31Manufacturing (CMC) · Supplement 42AP
1990-11-02Labeling · Supplement 35AP
1990-09-19Manufacturing (CMC) · Supplement 40AP
1990-09-13Manufacturing (CMC) · Supplement 39AP
1989-10-24Manufacturing (CMC) · Supplement 38AP
1989-07-14Manufacturing (CMC) · Supplement 37AP
1988-03-31Manufacturing (CMC) · Supplement 36AP
1984-11-13Manufacturing (CMC) · Supplement 33AP
1984-09-27Manufacturing (CMC) · Supplement 31AP
1984-06-12Labeling · Supplement 32AP
1984-05-16Manufacturing (CMC) · Supplement 29AP
1981-08-10Manufacturing (CMC) · Supplement 24AP
1981-08-10Manufacturing (CMC) · Supplement 22AP
1981-08-10Manufacturing (CMC) · Supplement 20AP
1981-08-10Labeling · Supplement 25AP
1981-08-10Labeling · Supplement 23AP
1981-08-10Labeling · Supplement 21AP
1981-04-14Manufacturing (CMC) · Supplement 19AP
1980-12-18Manufacturing (CMC) · Supplement 18AP
1980-12-18Manufacturing (CMC) · Supplement 17AP
1980-05-13Labeling · Supplement 12AP
1980-05-13Labeling · Supplement 10AP
1980-05-13Manufacturing (CMC) · Supplement 11AP
1979-07-18Manufacturing (CMC) · Supplement 5AP
1978-11-06Manufacturing (CMC) · Supplement 4AP
1978-11-06Manufacturing (CMC) · Supplement 3AP
1978-05-26Manufacturing (CMC) · Supplement 2AP
1978-02-21Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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