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FDA ANDA · ANDA078324

ESTRADIOL / NORETHINDRONE ACETATE

estradiol and norethindrone acetate

Sponsor: BRECKENRIDGE PHARM

APPLICATION
ANDA078324
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-17
LATEST ACTION
2026-04-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ESTRADIOL AND NORETHINDRONE ACETATEPrescription
ESTRADIOL 0.5MG, NORETHINDRONE ACETATE 0.1MG · TABLET · ORAL
ESTRADIOL AND NORETHINDRONE ACETATEPrescription
ESTRADIOL 1MG, NORETHINDRONE ACETATE 0.5MG · TABLET · ORAL

Approval history

2026-04-21Labeling · Supplement 7 · standardAP
2026-04-21Labeling · Supplement 5 · standardAP
2026-04-21Labeling · Supplement 10 · standardAP
2026-04-21Labeling · Supplement 8 · standardAP
2011-06-09Manufacturing (CMC) · Supplement 2AP
2008-04-17OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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