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FDA ANDA · ANDA209297

HAILEY 1.5/30

norethindrone acetate and ethinyl estradiol

Sponsor: GLENMARK SPECLT

APPLICATION
ANDA209297
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-05
LATEST ACTION
2023-08-23
ROUTE
ORAL, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HAILEY 1.5/30Prescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-21

Approval history

2023-08-23Labeling · Supplement 3 · standardAP
2023-08-23Labeling · Supplement 4 · standardAP
2018-06-05UNKNOWN · Original · standardAP
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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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