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FDA ANDA · ANDA202771

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Sponsor: XIROMED

APPLICATION
ANDA202771
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-06
LATEST ACTION
2024-04-02
ROUTE
ORAL, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-21

Approval history

2024-04-02Labeling · Supplement 9 · standardAP
2024-04-02Labeling · Supplement 7 · standardAP
2018-11-08Labeling · Supplement 3 · standardAP
2018-11-08Labeling · Supplement 1 · standardAP
2013-11-06UNKNOWN · OriginalAP
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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