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FDA NDA · NDA209627

ANNOVERA

segesterone acetate and ethinyl estradiol

Sponsor: MAYNE PHARMA

APPLICATION
NDA209627
TYPE
NDA
ORIGINAL APPROVAL
2018-08-10
LATEST ACTION
2022-04-29
ROUTE
VAGINAL
DOSAGE FORM
RING
MARKETING STATUS
Prescription

Products

ANNOVERA · ReferencePrescription
ETHINYL ESTRADIOL 0.013MG/24HR, SEGESTERONE ACETATE 0.15MG/24HR · RING · VAGINAL

Approval history

2022-04-29Labeling · Supplement 3 · standard — Label ↗AP
2018-08-10Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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