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FDA ANDA · ANDA205449

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norgestimate and ethinyl estradiol

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APPLICATION
ANDA205449
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-07
LATEST ACTION
2025-03-07
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MILIPrescription
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG · TABLET · ORAL-28

Approval history

2025-03-07Labeling · Supplement 4 · standardAP
2022-04-29Labeling · Supplement 3 · standardAP
2022-01-25Labeling · Supplement 1 · standardAP
2016-07-07UNKNOWN · 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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