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FDA ANDA · ANDA202995
MICROGESTIN 1/20
norethindrone acetate/ethinyl estradiol
Sponsor: NOVAST LABS
APPLICATION
ANDA202995
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-04
LATEST ACTION
2023-06-02
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LARIN 1/20Prescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-21
Approval history
2023-06-02Labeling · Supplement 10 · standardAP
2023-06-02Labeling · Supplement 2 · standardAP
2023-06-02Labeling · Supplement 9 · standardAP
2013-12-04UNKNOWN · OriginalAP
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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