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FDA ANDA · ANDA210612

ESTRADIOL AND NORETHINDRONE ACETATE

Sponsor: NOVAST LABS

APPLICATION
ANDA210612
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-03
LATEST ACTION
2024-05-31
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

2024-05-31Labeling · Supplement 5 · standardAP
2023-10-18Labeling · Supplement 3 · standardAP
2019-04-03UNKNOWN · Original · standardAP
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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